[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-myelodysplastic-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-myelodysplastic-syndrome":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,44,72,97,144,167,195,215,235,252,284],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100546798","phase-1-eltanexor-and-venetoclax-in-relapsed-or-refractory-myelodysplastic-syndrome-and-acute-myeloid-leukemia-100546798",false,"NCT06399640","Eltanexor and Venetoclax in Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia","Phase Ib Study of Eltanexor and Venetoclax in Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia","Inclusion Criteria:\n\n\\- Age \\>\u002F= 18 years at the time of signing the Informed Consent Form (ICF); must voluntarily sign an ICF; and must be able to meet all study requirements.\n\nFor Myelodysplastic Syndrome (MDS):\n\nMorphologically confirmed diagnosis of MDS with increased blasts (\\>\u002F= 5%), with a prior DNA methyltransferase inhibitor (DNMTi) treatment and progression after 2 cycles or stable disease after 4 cycles\n\nFor Acute Myeloid Leukemia (AML):\n\nMorphologically confirmed diagnosis of AML in accordance with WHO diagnostic criteria that is relapsed or refractory following \\>\u002F= 1 line(s) of therapy.\n\n* WBC must be less than 25,000\u002Ful prior to study start (hydroxyurea allowed).\n* A bone marrow aspirate must be performed, and tissue collected for entrance to the trial unless circulating blasts \\>\u002F= 5% in which case, peripheral blood can be used.\n* Eastern Cooperative Oncology Group Performance Status of 0 - 2.\n* Must have adequate hepatic and renal function as demonstrated by the following:\n\nALT(SGPT) and\u002For AST (SGOT) \\\u003C\u002F= 3x upper limit of normal (ULN); Direct bilirubin \\\u003C\u002F= 1.5 x ULN; or Total bilirubin \\\u003C\u002F= 2.5x ULN (known Gilbert's Syndrome as cause of elevated bilirubin is allowed); Calculated creatinine clearance \\> 50 ml\u002Fmin (per the Cockroft-Gault formula).\n\n\\- Willingness to abide by all study requirements, including contraception, maintenance of a pill diary, and acceptance of recommended supportive care medications.\n\nExclusion Criteria:\n\n* Anticancer therapy, including investigational agents \\\u003C\u002F= 2 weeks or \\\u003C\u002F= 5 half-lives of the drug, whichever is shorter, prior to C1D1. (Use of hydroxyurea is permitted).\n* Inadequate recovery from toxicity attributed to prior anti-cancer therapy to \\\u003C\u002F= Grade 1 (NCI CTCAE v5.0), excluding alopecia or fatigue.\n* Prior treatment with SINE compounds or other inhibitors of XPO1.\n* History of allogeneic hematopoietic stem cell transplant (HCT), or other cellular therapy product, within 3 months.\n* Active acute or chronic GVHD requiring calcineurin inhibitors or steroid dosing \\>\u002F= 10mg\u002Fday or patients within 4 weeks of stopping calcineurin inhibitors for GVHD.\n* Radiation therapy or major surgery within 3 weeks.\n* Active, uncontrolled infection. Patients with infection under active treatment and controlled with antibiotics are eligible. Prophylaxis, even if parenteral, is acceptable.\n* Inability to swallow oral medications.\n* Active documented central nervous system leukemia.\n* Second active malignancy within past 2 years except for basal or squamous cell carcinoma of the skin, ductal carcinoma of breast in situ or cervical carcinoma in situ.\n* Women of childbearing age or potential must have negative pregnancy test and must not be actively breastfeeding to enroll on the study\n* Clinically significant cardiovascular disease with major event or cardiac intervention within the past 6 months (e.g. percutaneous intervention, coronary artery bypass graft, documented cardiac heart failure) as determined by the investigator.\n* Any condition not listed but deemed by the investigator to make the patient a poor candidate for clinical trial and\u002For treatment with investigational agents.","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial tests the safety, side effects, and best dose of eltanexor in combination with venetoclax for the treatment of patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Eltanexor works by trapping \"tumor suppressing proteins\" within the cell, thus causing the cancer cells to die or stop growing. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving eltanexor together with venetoclax may be safe, tolerable and\u002For effective in treating patients with relapsed or refractory MDS or AML.",[26,27,28,29,30],"Relapsed Myelodysplastic Syndrome","Refractory Myelodysplastic Syndrome","Acute Myeloid Leukemia","Recurrent Acute Myeloid Leukemia","Refractory Acute Myeloid Leukemia","RECRUITING","2026-06-19",{"date":34,"type":35},"2026-06-24","ACTUAL",{"date":37,"type":35},"2024-08-14",{"date":39,"type":20},"2027-10-01",{"name":41,"class":42},"Vanderbilt-Ingram Cancer Center","OTHER",2,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100553282","phase-1-testing-the-anti-cancer-drug-cirtuvivint-and-its-combination-with-astx727-to-improve-outcomes-in-patients-with-acute-myeloid-leukemia-and-myelodysplastic-syndromes-100553282","NCT06484062","Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes","A Phase I Study Evaluating the Safety of Cirtuvivint as Monotherapy and in Combination With ASTX727 in Patients With Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n* In Cohorts I and II, patients must have R\u002FR AML or MDS (venetoclax naïve or venetoclax exposed)\n\n  * Relapsed AML is defined as the appearance of 5% or greater myeloblasts in the bone marrow or peripheral blood after achieving a complete remission (CR), CR with partial hematologic recovery (CRh), or CR with incomplete hematologic recovery (CRi). Patients with a mutation in FLT3, IDH1 or IDH2 must have failed or been intolerant of a corresponding Food and Drug Administration (FDA) approved FLT3, IDH1 or IDH2 inhibitor before enrolling on study. The initial diagnosis of AML is defined by the ELN 2022 criteria, and therefore patients with either AML (peripheral blood or bone marrow blasts ≥ 20% or blasts ≥ 10% with recurrent genetic abnormalities) or MDS\u002FAML (peripheral blood or bone marrow blasts 10-19%) are eligible\n  * Refractory AML is defined as failure to achieve a CR, CRh, or CRi after one of the following regimens: (i) ≥ 2 cycles of intensive induction chemotherapy with a cytarabine containing regimen (e.g., 7+3, mitoxantrone, etoposide, cytarabine \\[MEC\\], high-dose cytarabine \\[HIDAC\\], reinduction chemotherapy such as 5 + 2, etc.) or, (ii) ≥ 2 cycles of hypomethylating agent (HMA)\u002Fvenetoclax or low-dose cytarabine (LDAC)\u002Fglasdegib or, (iii) ≥ 4 cycles of HMA monotherapy. The initial diagnosis of AML is defined by the ELN 2022 criteria, and therefore patients with either AML (peripheral blood or bone marrow blasts ≥ 20% or blasts ≥ 10% with recurrent genetic abnormalities) or MDS\u002FAML (peripheral blood or bone marrow blasts 10-19%) are eligible\n  * Patients with MDS\u002FAML (blasts 10-19%) who progress to AML (blasts ≥ 20%) after treatment will be considered relapsed or refractory MDS\u002FAML, and not as newly-diagnosed AML (i.e. the patients' treatment history for eligibility purposes does not reset)\n  * Relapsed MDS is defined as: (i) Intermediate, high, or very high-risk disease by International Prognostic Scoring System-Revised (IPSS-R) and, (ii) Any relapse after achieving any 2023 IWG MDS defined response\n  * Refractory MDS is defined as: (i) Intermediate, high, or very high-risk disease by IPSS-R and \\> 5% blasts in the bone marrow or peripheral blood, (ii) Failure to achieve a response (as per IWG 2006 criteria) after ≥ 4 cycles of HMA monotherapy, or (iii) ≥ 2 cycles of HMA + venetoclax\n* In Cohort III, patients must have prior untreated high-risk MDS\n\n  * MDS with \\> 5% blasts in the bone marrow or peripheral blood AND\n  * IPSS-R high or very high-risk disease OR\n  * Molecular International Prognostic Scoring System (IPSS-M) high or very high-risk disease\n  * No more than one single prior cycle of DNMTi therapy\n  * Prior use of erythropoiesis stimulating agents (ESA), thrombopoietin agonists, lenalidomide, and luspatercept are allowed\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of SM08502 (cirtuvivint) in combination with ASTX727 in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3\n* Total bilirubin ≤ 2 x institutional upper limit of normal (ULN) (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin; in that case a cut off of ≤ 4 × institutional ULN will be used)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN (unless considered due to organ involvement by the patient's myeloid malignancy; in that case a cut off of ≤ 5 x institutional ULN will be used)\n* Glomerular filtration rate (GFR) ≥ 45 mL\u002Fmin\u002F1.73m\\^2\n* If female, patient must be either:\n\n  * Postmenopausal (surgically sterile or age \\> 55 years with no menses for 12 or more months without an alternative medical cause or age equal to 55 or less with no menses for 12 or more months without an alternative medical cause and a follicle stimulating hormone \\[FSH\\] level \\> 40 IU\u002FL); or\n  * Of children bearing potential. These patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Patient must agree to have a negative urine or serum beta-human chorionic gonadotropin (HCG) test result during screening and repeated within 7 days prior to study drug (local labs are allowed) to be eligible\n* The effects of SM08502 (cirtuvivint) and ASTX727 on the developing human fetus are unknown. For this reason, and because these agents are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and during the treatment therapy. Women of childbearing age should agree to use adequate contraception for 7 months after completion of SM08502 (cirtuvivint) administration. For ASTX727, adequate contraception must continue for at least 6 months after last dose of ASTX727. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of the study and at least 4 months after the last dose of SM08502 (cirtuvivint) and 3 months after last dose of ASTX727. Women who are lactating must refrain from breastfeed during the study and at least for two weeks after last dose of ASTX727\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia or abnormal blood counts\n* Patients who are receiving any other investigational agents\n* Systemic anti-leukemic or other antineoplastic therapy within 14 days of first day of study treatment. Hydroxyurea may be continued through cycle 1 of treatment. Hydroxyurea is discouraged in subsequent cycles and should be discussed beforehand with principal investigator. If on venetoclax, then a wash-out period of at least five times the half-life of venetoclax is required. Exceptions: No wash-out required for intrathecal chemotherapy, hydroxyurea, cytarabine (Ara-C), or palliative radiation therapy to painful sites of leukemic disease. Patients are not allowed to receive concurrent therapy such as cytotoxic chemotherapy or radiation therapy for another cancer. Patients on hormonal adjuvant therapy for non-metastatic breast and prostate cancer or other minimally-myelosuppressive maintenance therapies for non-metastatic cancer may be eligible at the discretion of the study principal investigator (PI)\n* Patient is receiving known inhibitors or activators of flavin-containing monooxygenases (FMO1 or FMO3), and these cannot be stopped at least 5 days prior to SM08502 (cirtuvivint) treatment start. Known inhibitors of FOMO are chlorpromazine and imipramine\n* Patient is receiving strong inhibitors or strong inducers of CYP3A4\u002F5 and these cannot be stopped at least 5 days prior to SM08502 (cirtuvivint) treatment start\n\n  * Strong inhibitors include grapefruit juice or grapefruit\u002Fgrapefruit related citrus fruits (e.g., Seville oranges, pomelos), ketoconazole, miconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, amprenavir, fosamprenavir, nefazodone, lopinavir, troleandomycin, mibefradil, and conivaptan. Examples may be found at the FDA website. Refer to the prescribing information of concomitant medications if in doubt or consult the sponsor for guidance\n  * Strong inducers include phenobarbital, rifampin, phenytoin, carbamazepine, rifabutin, rifapentin, clevidipine, and St. John's Wort. Examples may be found at the FDA website. Refer to the prescribing information of concomitant medications if in doubt or consult the sponsor for guidance.\n  * While moderate inhibitors or moderate inducers of CYP3A4\u002F5 are not an exclusion criteria for the trial, it is preferred that moderate inhibitors or moderate inducers of CYP3A4\u002F5 be replaced prior to the first dose of SM08502 (cirtuvivint) and during study conduct where this is possible.\n\n    * Moderate inhibitors include erythromycin, ciprofloxacin, verapamil, diltiazem, atazanavir, fluconazole, darunavir, delavirdine, amprenavir, fosamprenavir, aprepitant, imatinib, tofisopam, and cimetidine. Examples may be found at the FDA website. Refer to the prescribing information of concomitant medications if in doubt or consult the sponsor for guidance\n    * Moderate inducers include bosentan, efavirenz, etravirine, modafinil, and nafcillin. Examples may be found at the FDA website. Refer to the prescribing information of concomitant medications if in doubt or consult the sponsor for guidance\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to SM08502 (cirtuvivint) or ASTX727\n* Chronic, active hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: patients with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface \\[HBs\\] antigen negative, anti-HBs antibody positive and anti-hepatitis B core \\[HBc\\] antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate. Patients who had prior HCV that has been definitively treated with negative HCV viral load prior to study initiation and no evidence of cirrhosis, are allowed to participate. If there is no known history of HBV infection no HBV studies need to be obtained. If there is no known history of HCV infection, no HCV studies need to be obtained\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant and lactating women are excluded from this study because SM08502 (cirtuvivint) is a small molecule inhibitor of CLK DYRK with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with SM08502 (cirtuvivint), breastfeeding should be discontinued if the mother is treated with SM08502 (cirtuvivint). These potential risks may also apply to other agents used in this study\n* Patients with acute promyelocytic leukemia\n* Subject has symptomatic central nervous system (CNS) involvement with AML\n* Patient has immediate life-threatening, severe complications of their myeloid malignancy such as uncontrolled bleeding and\u002For uncontrolled infection\n* Patient has significant active cardiac disease within 6 months prior to the start of study treatment, including uncontrolled New York Heart Association (NYHA) class III or IV congestive heart failure; acute coronary syndrome (ACS); and\u002For stroke\n* Left ventricular ejection fraction (LVEF) \\\u003C 40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan obtained within 30 days prior to the start of study treatment\n* Patient is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally. Patient needs to be able to swallow pills\n* Patient has active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and\u002For other treatment)\n* Subject has prolonged corrected QC (QTc) interval (Fridericia's correction \\[QTcF\\]) ≥ 480 ms or known family history of long QT interval syndrome at screening",{"count":52,"type":20},54,[23],"This phase I trial tests the safety, side effects, and best dose of SM08502 (cirtuvivint) alone and in combination with ASTX727 in treating patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Cirtuvivint may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. ASTX727 is a combination of two drugs, decitabine and cedazuridine. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Giving cirtuvivint alone or in combination with ASTX727 may be safe, tolerable, and\u002For effective in treating patients with AML and MDS.",[28,56,57,29,58,59,30,27,60],"Myelodysplastic Syndrome","Myelodysplastic Syndrome\u002FAcute Myeloid Leukemia","Recurrent Myelodysplastic Syndrome","Recurrent Myelodysplastic Syndrome\u002FAcute Myeloid Leukemia","Refractory Myelodysplastic Syndrome\u002FAcute Myeloid Leukemia","2026-06-10",{"date":63,"type":35},"2026-06-11",{"date":65,"type":35},"2025-08-15",{"date":67,"type":20},"2028-06-01",{"name":69,"class":70},"National Cancer Institute (NCI)","NIH",22,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100380866","phase-2-a-phase-ii-open-label-study-of-subcutaneous-canakinumab-an-anti-il-1-human-monoclonal-antibody-for-patients-with-low-or-int-1-risk-ipssipss-r-myelodysplastic-syndromes-and-chronic-myelomonocytic-leukemia-100380866","NCT04239157","A Phase II, Open-Label, Study of Subcutaneous Canakinumab, an Anti-IL-1β Human Monoclonal Antibody, for Patients With Low or Int-1 Risk IPSS\u002FIPSS-R Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia","Inclusion Criteria:\n\n* Age ≥ 18 years as MDS and CCUS are very rare conditions in the pediatric setting.\n* Cohorts 1-3: Diagnosis of MDS according to WHO 2016 classification and low or intermediate-1 risk by IPSS or IPSS-R with a score of ≤ 3.5.\n* Cohort 4: Diagnosis of CCUS defined as:\n* Presence of a somatic pathogenic variant associated with hematological malignancy without morphological evidence of myelodysplasia\n* Variant allele fraction of greater than or equal to 2% in at least one identified somatic pathogenic variant\n* Bone marrow aspirate excluding hematological malignancy and MDS\n\n  * Presence of a cytopenia for \\>30 days. Cytopenia will be defined using accepted CHRS (Clonal Hematopoiesis Risk Score) criteria (Weeks et al, NEJM Evidence in press): ANC \\\u003C1.8 or hgb \\\u003C12 in females and \\\u003C13 in males or a platelet count of \\\u003C150.\n* Cohort 1: Participants need to have not responded to prior therapy with ESAs or hypomethylating agents (HMAs). These could include azacitidine, decitabine, SGI-110, ASTX727, or CC-486. Patients will need to have received at least 4 cycles of HMA. Participants with relapse or progression after any number of cycles of HMA by IWG 2006 criteria will also be candidates. Participants with evidence of del 5q alteration also are required to have been treated with Lenalidomide.\n* Cohort 1: Hemoglobin \\\u003C10g\u002FdL with symptomatic anemia or transfusion dependency defined as the need for prior transfusion in the past 8 weeks for a hemoglobin level less than 8g\u002Fdl.\n* Cohort 2: Transfusion dependency defined as the need for prior transfusion in the past 8 weeks of (1) at least 2 units of PRBC for a hemoglobin level less than 8g\u002Fdl or symptomatic anemia (hemoglobin \\\u003C10g\u002FdL), or (2) any platelet transfusion.\n* Participants (or patient's legally authorized representative) must have signed an informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study.\n* Adequate hepatic function with total bilirubin \\\u003C\u002F=3 x ULN, AST or ALT \\\u003C\u002F= 3xULN.\n* Serum creatinine clearance \\>30mL\u002Fmin and no end\u002Fstage renal disease (using Cockcroft-Gault).\n* ECOG performance status \\\u003C\u002F=2.\n\nExclusion Criteria:\n\n* Active infection not adequately responding to appropriate antibiotics.\n* Prior treatment with IL-1\u002FIL-1r inhibitors\n* Absolute neutrophil count (ANC) \\\u003C0.5x109 k\u002Ful; colony-stimulating factors can be administered prior to study drug initiation.\n* Female participants who are pregnant or lactating.\n* Participants with reproductive potential who are unwilling to following contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives \\[birth control pills\\], contraceptive injections, intrauterine devices \\[IUD\\], double-barrier method \\[spermicidal jelly or foam with condoms or diaphragm\\], contraceptive patch, or surgical sterilization) throughout the study. Reproductive potential is defined as no previous surgical sterilization or females that are not post-menopausal for 12 months.\n* Female participants with reproductive potential who do not have a negative urine or blood beta-human chorionic gonadotropin (beta HCG) pregnancy test at screening.\n* History of an active malignancy within the past 2 years prior to study entry, with the exception of: a. Adequately treated in situ carcinoma of the cervix uteri b. Adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin or any other malignancy with a life expectancy of more than 2 years.\n* Participants receiving any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy (within 14 days of initiating study treatment).\n* Known history of testing positive for Human Immunodeficiency Virus (HIV) infections.\n\nParticipants requiring systemic steroids, methotrexate or other immunosuppressive drugs will not be included in the study.",{"count":79,"type":20},76,[81],"PHASE2","This phase II trial studies how well canakinumab works for the treatment of low- or intermediate-risk myelodysplastic syndrome or chronic myelomonocytic leukemia. Canakinumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.",[84,56,85,58,86,27],"Chronic Myelomonocytic Leukemia","Recurrent Chronic Myelomonocytic Leukemia","Refractory Chronic Myelomonocytic Leukemia","2026-05-18",{"date":89,"type":35},"2026-05-20",{"date":91,"type":35},"2020-08-25",{"date":93,"type":20},"2026-12-31",{"name":95,"class":42},"M.D. Anderson Cancer Center",1,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":108,"conditions":109,"keywords":132,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":96},"100310864","phase-1-ha-1-t-tcr-t-cell-immunotherapy-for-the-treatment-of-patients-with-relapsed-or-refractory-acute-leukemia-after-donor-stem-cell-transplant-100310864","NCT03326921","HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant","Phase I Study of Adoptive Immunotherapy With CD8+ and CD4+ Memory T Cells Transduced to Express an HA-1-Specific T Cell Receptor (TCR) for Children and Adults With Recurrent Acute Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation (HCT)","Inclusion Criteria:\n\n* Subject age 0-80 years at the time of enrollment.\n* Subject must express HLA-A\\*0201\n* Subject must have the HA-1(H) genotype (RS\\_1801284: A\u002FG, A\u002FA)\n* Subject must have an adult donor for HCT who is adequately HLA matched by institutional standards (includes HLA-matched related or unrelated donors, and HLA-mismatched family donors, including haploidentical donors) and is either:\n\n  * HLA-A\\*0201 positive and HA-1(H) negative (RS\\_1801284: G\u002FG) or\n  * HLA-A\\*0201 negative\n* Subjects who are currently undergoing or who previously underwent allogeneic HCT for\n\n  * Acute myeloid leukemia (AML) of any subtype\n  * Acute lymphoid leukemia (ALL) of any subtype\n  * Mixed phenotype\u002Fundifferentiated\u002Fany other type of acute leukemia, including blastic plasmacytoid dendritic cell neoplasm\n  * Chronic myeloid leukemia with a history of blast crisis and:\n\n    * With relapse or refractory disease (\\>= 5% marrow blasts, or circulating blasts) at any time after HCT\n    * With persistent rising minimal residual disease (defined as detectable disease by morphology, flow cytometry, molecular or cytogenetic testing but \\\u003C 5% marrow blasts by morphology, no circulating blasts on \\>= 2 of two consecutive tests), refractory or ineligible for treatment with tyrosine kinase inhibitors at any time after HCT\n  * Myelodysplastic syndrome (MDS) of any subtype\n  * Chronic myelomonocytic leukemia (CMML)\n  * Juvenile myelomonocytic leukemia (JMML)\n* Subjects must be able to understand and be willing to give informed consent; decision-impaired adults may consent with their legally authorized representative; parent or legal representative will be asked to consent for subjects younger than 18 years old\n* Subjects must agree to participate in long-term follow-up for up to 15 years if they are enrolled in the study and receive T cell infusion\n* Subjects who have relapsed or have MRD after HCT may receive other agents for treatment of disease and remain eligible for the protocol\n* A specific performance status score is not required for enrolling on the protocol; a delay in infusion of the HA-1 TCR T cells may be required for subjects with low performance status\n\nDONOR SELECTION INCLUSION\n\n* Donor age \\>= 18 years\n* Donors must be able to give informed consent\n\nExclusion Criteria:\n\n* Medical or psychological conditions that would make the subject unsuitable candidate for cell therapy at the discretion of the principal investigator (PI)\n* Fertile subjects unwilling to use contraception during and for 12 months after treatment\n* Subjects with a life expectancy of \\\u003C 3 months of enrollment from coexisting disease other than leukemia\n* Subjects who have ongoing grade IV acute GVHD or severe chronic GVHD following most recent transplant. Exception: the principal investigator (PI) may make an exception on a case-by-case basis to include such a subject if there is doubt surrounding the GVHD diagnosis and\u002For sustained significant improvement in GVHD severity\n* The presence of organ toxicities will not necessarily exclude subjects from enrolling on the protocol at the discretion of the PI; however, a delay in the infusion of HA-1 TCR T cells may be required\n\nDONOR SELECTION EXCLUSION\n\n* Donors who are human immunodeficiency virus (HIV)-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2 seropositive or with active hepatitis B or hepatitis C virus infection\n* Unrelated donor residing outside of the United States of America (USA) unless the donor screening, testing and leukapheresis occur at an National Marrow Donor Program (NMDP)-affiliated and qualified donor center and are facilitated by the NMDP","80 Years",{"count":106,"type":20},24,[23],"This phase I trial studies the side effects and best dose of CD4+ and CD8+ HA-1 T cell receptor (TCR) (HA-1 T TCR) T cells in treating patients with acute leukemia that persists, has come back (recurrent) or does not respond to treatment (refractory) following donor stem cell transplant. T cell receptor is a special protein on T cells that helps them recognize proteins on other cells including leukemia. HA-1 is a protein that is present on the surface of some peoples' blood cells, including leukemia. HA-1 T cell immunotherapy enables genes to be added to the donor cells to make them recognize HA-1 markers on leukemia cells.",[110,111,112,113,114,115,116,117,118,58,119,27,120,121,122,123,124,29,56,28,125,126,127,84,128,85,129,130,131],"Juvenile Myelomonocytic Leukemia","Recurrent Acute Biphenotypic Leukemia","Recurrent Acute Undifferentiated Leukemia","Recurrent Childhood Acute Lymphoblastic Leukemia","Recurrent Childhood Acute Myeloid Leukemia","Refractory Acute Lymphoblastic Leukemia","Refractory Adult Acute Lymphoblastic Leukemia","Blast Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm","Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm","Acute Undifferentiated Leukemia","Mixed Phenotype Acute Leukemia","Recurrent Chronic Myeloid Leukemia, BCR-ABL1 Positive","Refractory Chronic Myeloid Leukemia, BCR-ABL1 Positive","Recurrent Acute Lymphoblastic Leukemia","Acute Lymphoblastic Leukemia","Acute Biphenotypic Leukemia","Chronic Myeloid Leukemia","Minimal Residual Disease","Recurrent Mixed Phenotype Acute Leukemia","Leukemia","Chronic Myeloid Leukemia, BCR-ABL1 Positive",[133,134,135,130],"HA-1","TCR","Immunotherapy","2026-05-15",{"date":87,"type":35},{"date":139,"type":35},"2018-02-23",{"date":141,"type":20},"2028-07-16",{"name":143,"class":42},"Fred Hutchinson Cancer Center",{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":151,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":21,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":96},"100587459","phase-1-chemotherapy-decitabine-in-combination-with-flag-ida-and-total-body-irradiation-followed-by-donor-stem-cell-transplant-for-the-treatment-of-adults-with-myeloid-malignancies-at-high-risk-of-relapse-100587459","NCT06928662","Chemotherapy (Decitabine in Combination With FLAG-Ida) and Total-Body Irradiation Followed by Donor Stem Cell Transplant for the Treatment of Adults With Myeloid Malignancies at High Risk of Relapse","Sequential Decitabine in Combination With FLAG-Ida Followed Immediately by Reduced-Intensity Conditioning (RIC) Allogeneic Hematopoietic Cell Transplantation (DEC-FLAG-Ida\u002FRIC) for Adults With Myeloid Malignancies at High Risk of Relapse: A Phase 1\u002F2 Study","Inclusion Criteria:\n\n* Age ≥ 18 years with an HCT-co-morbidity index (CI) ≤ 5 for patients over 60 years.\n* AML (2022 World Health Organization \\[WHO\\] criteria) that is either primary refractory (as defined by failure of 2 cycles of 7+3-like chemotherapy, 1 cycle of high-dose cytarabine-based chemotherapy, or at least 2 cycles of venetoclax in combination with other therapies) or is in untreated or unsuccessfully treated first or subsequent relapse. Patients in morphologic remission (i.e. \\\u003C 5% blasts in the bone marrow) but evidence of minimal residual disease (MRD) by multiparameter flow cytometry, cytogenetics\u002Ffluorescence in situ hybridization (FISH), or molecular means will be eligible for trial participation. Patients with relapsed or refractory acute leukemia of ambiguous lineage (acute undifferentiated leukemia or mixed phenotype acute leukemia) that is either primary refractory or is in untreated or unsuccessfully treated first or subsequent relapse are also eligible.\n* MDS and CMML: Subjects with previously treated MDS and CMML, defined as prior treatment with at least one hypomethylating agent (hypomethylating agent \\[HMA\\]; azacitidine, decitabine and\u002For decitabine-cedazuridine) whose disease progressed, relapsed, or was refractory to HMA treatment as follows: 1) patients who have failed at least 4 cycles of monotherapy with azacitidine, decitabine or decitabine-cedazuridine, 2) patients who received at least 2 cycles of HMA in combination with another therapeutic agent. Subjects with MDS and CMML who failed at least 1 cycle of induction chemotherapy will be also eligible. Patients with MDS or CMML who progress to secondary AML will be eligible if they received at least 4 cycles of HMA alone or 2 cycles of HMA in combination with another therapeutic agent.\n* Patients may have previously received hypomethylating agents or chemotherapy with a mitoxantrone, idarubicin- or cladribine\u002Ffludarabine-based regimen for MDS or AML. If the patient has received cladribine-cytarabine-filgrastim-mitoxantrone (CLAG-M) or FLAG-Ida before and has been sensitive to this regimen, defined as MRD negative complete remission (CR) immediately after receiving the treatment and which lasts ≥ 1 year, eligibility will be determined on a case-by-case basis by the study principal investigator (PI).\n* The use of hydroxyurea prior to initiation of study treatment is allowed. Patients with symptoms\u002Fsigns of hyperleukocytosis, white blood cells (WBC) \\> 100,000\u002FμL or with concern for other complications of high tumor burden of high tumor dynamics (e.g. disseminated intravascular coagulation) can be treated with leukapheresis or may receive up to 2 doses of cytarabine (up to 500 mg\u002Fm\\^2 per dose) prior to start of study treatment.\n* Karnofsky score ≥ 70; Eastern Cooperative Oncology Group (ECOG) 0-1.\n* Adequate cardiac function defined as absence of decompensated congestive heart failure and\u002For uncontrolled arrhythmia and left ventricular ejection fraction ≥ 45%.\n* Bilirubin ≤ 2.5 x Institutional Upper Limit of Normal unless elevation is thought to be due to hepatic infiltration by AML, Gilbert's syndrome, or hemolysis\n* Adequate pulmonary function defined as absence of oxygen (O2) requirements and either diffusion capacity of the lung for carbon monoxide (DLCO) corrected ≥ 70%mmHg or DLCO corrected 60-69%mmHg and partial pressure of oxygen (pO2) ≥ 70mmHg.\n* Creatinine clearance \\> 60 mL\u002Fmin.\n* Prior autologous HCT is permissible if relapse occurred \\> 6 months after HCT.\n* Prior TBI-containing allogeneic HCT up to 3 Gy is permissible if \\> 6 months after HCT.\n* A human leukocyte antigen (HLA)-matched sibling\u002Funrelated donor, mismatched unrelated donor or haploidentical donor for collection of stimulated peripheral blood stem cells must be identified and readily available.\n* Ability to understand and sign a written informed consent document (or legal representative).\n* SIBLING DONOR: Related to the patient and genotypically or phenotypically identical for HLA-A, B, C, DRB1 and DQB1. Phenotypic identity must be confirmed by high-resolution typing.\n* MATCHED UNRELATED DONOR: Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; OR mismatched for a single allele without antigen mismatching at HLA-A, B, or C as defined by high resolution typing but otherwise matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing.\n* MATCHED UNRELATED DONOR: Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment. The recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain panel reactive antibody (PRA) screens to class I and class II antigens for all patients before HCT. If the PRA shows \\> 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained. The donor should be excluded if any of the cytotoxic cross match assays are positive. For those patients with an HLA Class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results. A positive anti-donor cytotoxic crossmatch is an absolute donor exclusion.\n* MATCHED UNRELATED DONOR: Patient and donor pairs homozygous at a mismatched allele in the graft rejection vector are considered a two-allele mismatch, i.e., the patient is A\\*0101 and the donor is A\\*0102, and this type of mismatch is not allowed.\n* MISMATCHED UNRELATED DONOR: HLA-matching must be based on results of high resolution typing at HLA-A, -B, -C, -DRB1, and -DQ.\n* MISMATCHED UNRELATED DONOR: Mismatch for one HLA class I antigen with or without an additional mismatch for one HLA-class I allele but matched for HLA-DRB1 and HLA-DQ.\n* MISMATCHED UNRELATED DONOR: Mismatched for two HLA class I alleles but matched for HLA-DRB1 and HLA-DQ.\n* MISMATCHED UNRELATED DONOR: HLA class I HLA-A, -B, -C allele matched donors allowing for any one or two DRB1 and\u002For DQB1 antigen\u002Fallele mismatch.\n* MISMATCHED UNRELATED DONOR: If the patient is homozygous at the mismatch HLA class I locus or II locus, the donor must be heterozygous at that locus and one allele must match the patient (i.e., patient is homozygous A\\*01:01 and donor is heterozygous A\\*01:01, A\\*02:01). This mismatch will be considered a one-antigen mismatch for rejection only.\n* HAPLOIDENTICAL DONOR: Donors must be haploidentical relatives of the patients. Donor-recipient compatibility will be tested through HLA typing at high resolution for the HLA loci (-A, -B, -C, -DRB1, -DQB1). Donor and recipient should share at least 5\u002F10 HLA loci.\n* HAPLOIDENTICAL DONOR: Age ≥ 18 years.\n* HAPLOIDENTICAL DONOR: Weight ≥ 40 kg.\n* HAPLOIDENTICAL DONOR: Donor must meet the selection criteria as defined by the Foundation of the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) guidelines.\n* DONOR: In case of more available donors, selection criteria should include, in this order:\n\n  * For cytomegalovirus (CMV) seronegative recipients, a CMV seronegative donor\n  * Red Blood Cell compatibility\n\n    * Red blood cell (RBC) cross match compatible\n    * Minor ABO incompatibility\n    * Major ABO incompatibility\n* DONOR: Donors will undergo diagnostic evaluation (clinical, laboratory test and imaging) as indicated per institutional guidelines.\n\nExclusion Criteria:\n\n* Active central nervous system (CNS) disease.\n* Concomitant illness associated with a likely survival of \\\u003C 1 year.\n* Active systemic fungal, bacterial, viral, or other infection, unless disease is under treatment with antimicrobials and\u002For controlled or stable. Patients with fever thought to be likely secondary to myeloid malignancy are eligible.\n* Known hypersensitivity or contraindication to any study drug used in this trial.\n* Pregnancy or lactation.\n* Concurrent treatment with any other approved or investigational anti-leukemia agent.\n* HAPLOIDENTICAL DONOR: Since detection of anti-donor-specific antibodies (anti-DSA) is associated with higher graft rejection rate, patients will be screened for anti-DSA pre-transplant. Patient with DSA mean fluorescent intensity (MFI) \\\u003C 5000 after desensitization treatment, will be considered eligible to participate in the study.",true,{"count":153,"type":20},36,[23,81],"This phase I\u002FII trial studies the safety, side effects, and best dose of decitabine in combination with fludarabine, cytarabine, filgrastim, and idarubicin (FLAG-Ida) and total body irradiation (TBI) followed by a donor stem cell transplant in treating adult patients with cancers of blood-forming cells of the bone marrow (myeloid malignancies) that are at high risk of coming back after treatment (relapse). Cancers eligible for this trial are acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and chronic myelomonocytic leukemia (CMML). Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. The FLAG-Ida regimen consists of the following drugs: fludarabine, cytarabine, filgrastim, and idarubicin. These are chemotherapy drugs that work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Filgrastim is in a class of medications called colony-stimulating factors. It works by helping the body make more neutrophils, a type of white blood cell. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. TBI is radiation therapy to the entire body. Giving chemotherapy and TBI before a donor peripheral blood stem cell (PBSC) transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When the healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets. Giving decitabine in combination with FLAG-Ida and TBI before donor PBSC transplant may work better than FLAG-Ida and TBI alone in treating adult patients with myeloid malignancies at high risk of relapse.",[28,120,121,29,112,85,129,58,30,157,86,158,27,159],"Refractory Acute Undifferentiated Leukemia","Refractory Mixed Phenotype Acute Leukemia","Secondary Acute Myeloid Leukemia","2026-05-13",{"date":136,"type":35},{"date":163,"type":35},"2025-09-23",{"date":165,"type":20},"2028-11-29",{"name":143,"class":42},{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":21,"phases":176,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":185,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":96},"100639858","phase-2-total-marrow-and-lymphoid-irradiation-in-combination-with-fludarabine-and-melphalan-as-conditioning-for-allogeneic-peripheral-blood-stem-cell-hematopoietic-cell-transplant-in-older-patients-with-refractory-and-relapsed-acute-myeloid-leukemia-and-high-risk-myelodysplastic-syndrome-100639858","NCT07582172","Total Marrow and Lymphoid Irradiation in Combination With Fludarabine and Melphalan as Conditioning for Allogeneic Peripheral Blood Stem Cell Hematopoietic Cell Transplant in Older Patients With Refractory and Relapsed Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome","Phase 2 Trial of Total Marrow and Lymphoid Irradiation (TMLI) as Conditioning for Allogeneic Peripheral Blood Stem Cell Hematopoietic Cell Transplantation (PBSC-HCT) From a Match Donor With Fludarabine and Melphalan in Older Patients With Refractory Acute Myeloid Leukemia and MDS","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 50 years (no upper age limit)\n\n  * Note: Patients ≥ 18 years and \\\u003C 50 years are also included if they are not candidates for myeloablative conditioning regimens due to comorbidities or active disease\n* Karnofsky or Lansky performance status ≥ 70\n* Eligible patients will have a histopathological confirmed diagnosis of hematologic malignancy in one of the following categories:\n\n  * Acute myeloid leukemia (AML):\n\n    * Patients with de novo or secondary disease in unfavorable risk group including poor risk cytogenetics according to National Comprehensive Cancer Network (NCCN) guidelines for AML i.e., monosomal karyotype, -5,5q-,-7,7q-,11q23-non t(9;11), inv (3), t(3;3), t(6;9), t(9;22) and complex karyotypes (≥ 3 unrelated abnormalities), or all patient in intermediate risk groups\n    * Patients with active disease:\n\n      * Morphologically\n      * Minimal residual disease (MRD) testing (MRD+ through flow cytometry, cytogenetics, or molecular assays)\n  * Myelodysplastic syndrome\u002Fchronic myelomonocytic leukemia (CMML) (MDS) with ≥ 10% blast\n* Patients must have an human leukocyte antigen (HLA) (A, B, C, and DRB1) identical sibling or a 8\u002F8 (A, B, C, and DR) allele matched unrelated donor who is willing to donate primed blood stem cells\n* Serum direct bilirubin ≤ 2.0 x upper limit of normal (ULN) (unless has Gilbert's disease) (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n* Aspartate aminotransferase (AST) ≤ 2.5 x ULN (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n* Alanine aminotransferase (ALT) ≤ 2.5 x ULN (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n* Creatinine clearance of ≥ 60 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n\n  * Note: To be performed within 35 days prior to day 1 of protocol therapy\n* If able to perform pulmonary function tests: Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and DLCO (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin)\n\n  * Note: To be performed within 35 days prior to day 1 of protocol therapy\n* If unable to perform pulmonary function tests: Oxygen (O2) saturation \\> 92% on room air\n\n  * Note: To be performed within 35 days prior to day 1 of protocol therapy\n* Seronegative for HIV antigen (Ag)\u002Fantibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable\n  * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Meets institutional and federal requirements for infectious disease titer requirements\n\n  * Note: Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Allogeneic stem cell transplant or autologous HCT within 1 year prior to day 1 of protocol therapy\n* Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days of day 1 of protocol therapy\n\n  * Note: Low dose chemotherapy or maintenance chemotherapy given within 7 days of planned study enrollment is permitted. These include hydroxyurea, 6-meraptopurine, oral methotrexate, vincristine, oral etoposide, and tyrosine kinase inhibitors (TKIs). TKIs can also be given up to 3-5 days before conditioning regimen\n* More than three previous lines of intensive chemotherapy, where the regimen intent was to induce remission\n* Co-enrollment in other clinical trials involving post-HCT maintenance interventions or any study with potential to affect disease-free survival is not allowed\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Clinically significant uncontrolled illness\n* Active infection not responding to antibiotics\n* Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":175,"type":20},35,[81],"This phase II trial tests the effect of total marrow and lymphoid irradiation (TMLI) in combination with fludarabine and melphalan as conditioning regimen in older patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has not responded to previous treatment (refractory) and that has come back after a period of improvement (relapsed) and are undergoing a donor (allogeneic) peripheral blood stem cell (PBSC) hematopoietic cell transplant (HCT) from a matched related or unrelated donor. HCT is the only curative treatment for high-risk patients, but the side effects related to the current conditioning treatments limit the use to younger and more fit patients. TMLI is a targeted form of total body radiation that uses intensity-modulated radiation therapy to target marrow, lymph node chains, and the spleen. It is designed to reduce radiation-associated side effects and maximize the radiation therapeutic effect. Fludarabine blocks cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. It is a type of purine antagonist and a type of ribonucleotide reductase inhibitor. Melphalan is in a class of medications called alkylating agents. It may kill cancer cells by damaging their DNA and stopping them from dividing. Giving chemotherapy, such as fludarabine and melphalan, and TMLI before an allogeneic transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells to grow. When healthy stem cells from a related or unrelated donor, such as PBSC HCT, that closely match the patient's blood, are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets, an may help destroy any remaining cancer cells. Giving TMLI in combination with fludarabine and melphalan as conditioning treatment for an allogeneic PBSC HCT from a matched related or unrelated donor may be safe, tolerable, and\u002For effective in treating high-risk older patients with relapsed and refractory acute myeloid leukemia or high-risk myelodysplastic syndrome.",[179,180,56,29,181,58,182,30,183,27,184],"Acute Myeloid Leukemia With Complex Karyotype","Myelodysplastic Chronic Myelomonocytic Leukemia","Recurrent Myelodysplastic Chronic Myelomonocytic Leukemia","Recurrent Secondary Acute Myeloid Leukemia","Refractory Myelodysplastic Chronic Myelomonocytic Leukemia","Refractory Secondary Acute Myeloid Leukemia","NOT_YET_RECRUITING","2026-05-06",{"date":188,"type":35},"2026-05-12",{"date":190,"type":20},"2027-04-05",{"date":192,"type":20},"2029-04-05",{"name":194,"class":42},"City of Hope Medical Center",{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":21,"phases":204,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":96},"100239243","phase-1-onc201-in-treating-patients-with-relapsed-or-refractory-acute-leukemia-or-high-risk-myelodysplastic-syndrome-100239243","NCT02392572","ONC201 in Treating Patients With Relapsed or Refractory Acute Leukemia or High-Risk Myelodysplastic Syndrome","Phase I\u002FII Study of Oral ONC201 in Patients With Relapsed or Refractory Acute Leukemias and High-Risk Myelodysplastic Syndromes","Inclusion Criteria:\n\n* For Arms A, B, C, D, E, F patients must have relapsed or refractory acute leukemias or high-risk MDS for which no standard therapies are anticipated to result in a durable remission\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device \\[IUD\\], oral contraceptive or double barrier device, such as a condom, diaphragm, or cervical\u002Fvault cap), for 16 weeks after the last dose of study drug, and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial; nursing patients are excluded; sexually active men must also use acceptable contraceptive methods for the duration of time on study and for at least 16 weeks after the last dose of study drug; pregnant and nursing patients are excluded because the effects of ONC201on a fetus or nursing child are unknown\n* Must be able and willing to give written informed consent\n* The interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents; if the patient is on hydroxyurea to control peripheral blood leukemic cell counts, the patient must be off hydroxyurea for at least 24 hours before initiation of treatment on this protocol; persistent clinically significant toxicities from prior therapy must not be greater than grade 1\n* Serum creatinine \\\u003C 2.0 mg\u002Fdl\n* Total bilirubin =\\\u003C 1.5 x the upper limit of normal (ULN) unless considered due to Gilbert's syndrome\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =\\\u003C 3 x the ULN unless considered due to organ leukemic involvement\n* Relapse \\> 6 months since autologous or allogeneic stem cell transplantation provided:\n\n  * No active graft-versus-host disease (GVHD \\> grade 1)\n  * No treatment with high dose steroids for GVHD (up to \\>= 20 mg prednisolone or equivalent per day)\n  * No treatment with immunosuppressive drugs with the exception of low dose cyclosporine and tacrolimus\n\nExclusion Criteria:\n\n* Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure (New York Heart Association class III and IV), uncontrolled cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure (New York Heart Association class III and IV)\n* Patients receiving any other standard or investigational treatment for their hematologic malignancy within past 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents\n* Subject has been diagnosed or treated for another malignancy within 3 years of enrolment, except in situ malignancy, or low-risk prostate, skin or cervix cancer after curative therapy\n* Known history of seropositive for human immunodeficiency virus (HIV) antibodies (HIV1 and HIV2), hepatitis C antibody (Hep C Ab) or a hepatitis B carrier (positive for hepatitis B surface antigen \\[HBsAg\\])\n* Active drug use or alcoholism\n* Known or active central nervous system (CNS) involvement by leukemia\n* White blood cell count more than 25 x 109\u002FL prior to initiation of venetoclax",{"count":203,"type":20},120,[23,81],"This phase I\u002FII trial studies the side effects and best dose of ONC201 and to see how well it works in treating patients with acute leukemia or high-risk myelodysplastic syndrome that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). ONC201 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.",[124,29,58,115,30,27],"2026-04-10",{"date":209,"type":35},"2026-04-14",{"date":211,"type":35},"2015-11-03",{"date":213,"type":20},"2026-11-30",{"name":95,"class":42},{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":21,"phases":223,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":96},"100391334","phase-1-clag-m-or-flag-ida-chemotherapy-and-reduced-intensity-conditioning-donor-stem-cell-transplant-for-the-treatment-of-relapsed-or-refractory-acute-myeloid-leukemia-myelodysplastic-syndrome-or-chronic-myelomonocytic-leukemia-100391334","NCT04375631","CLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia","CLAG-M or FLAG-Ida Chemotherapy Followed Immediately by Related\u002FUnrelated Reduced-Intensity Conditioning (RIC) Allogeneic Hematopoietic Cell Transplantation for Adults With Myeloid Malignancies at High Risk of Relapse: A Phase 1 Study","Inclusion Criteria:\n\n* Age \\>= 18 years with an Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) =\\\u003C 5 for patients over 60 years -(Enrollment of patients \\>= 75 years of age will require case presentation at the transplant Patient Care Conference (PCC) and approval by consensus)\n* Acute myeloid leukemia (AML) (2016 World Health Organization \\[WHO\\] criteria) that is either primary refractory (as defined by failure of 2 cycles of 7+3-like chemotherapy, 1 cycle of high-dose cytarabine-based chemotherapy, or at least 2 cycles of venetoclax in combination with other therapies), or is in untreated or unsuccessfully treated first or subsequent relapse. Patients in morphological remission (i.e. \\\u003C 5% blasts in the bone marrow) but evidence of minimal residual disease (MRD) by multiparameter flow cytometry, cytogenetics\u002Ffluorescence in situ hybridization (FISH), or molecular means will be eligible for trial participation. Patients with relapsed or refractory acute leukemia of ambiguous lineage (acute undifferentiated leukemia, mixed phenotype acute leukemia) that is either primary refractory or is in untreated or unsuccessfully treated first or subsequent relapse are also eligible\n* Subjects with previously treated myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML), defined as prior treatment with at least one hypomethylating agent (HMA; azacitidine and\u002For decitabine) whose disease progressed, relapsed, or was refractory to HMA treatment as follows: 1) patients who have failed at least 4 cycles of monotherapy with azacitidine or decitabine, 2) patients who received at least 2 cycles of HMA in combination with another therapeutic agent. Subjects with MDS and CMML who failed at least 1 cycle of induction chemotherapy will be also eligible\n* The use of hydroxyurea prior to initiation of study treatment is allowed. Patients with symptoms\u002Fsigns of hyperleukocytosis, WBC \\> 100,000\u002FuL or with concern for other complications of high tumor burden (e.g. disseminated intravascular coagulation) can be treated with leukapheresis or may receive up to 2 doses of cytarabine (up to 500 mg\u002Fm\\^2 per dose) prior to start of study treatment\n* Karnofsky score \\>= 70; Eastern Cooperative Oncology Group (ECOG) 0-1\n* Adequate cardiac function defined as absence of decompensated congestive heart failure and\u002For uncontrolled arrhythmia and left ventricular ejection fraction \\>= 45%\n* Bilirubin =\\\u003C 2.5 x institutional upper limit of normal unless elevation is thought to be due to hepatic infiltration by AML, Gilbert's syndrome, or hemolysis\n* Adequate pulmonary function defined as absence of oxygen (O2) requirements and either carbon monoxide diffusing capability test (DLCO) correct \\>= 70% mmHg or DLCO corrected 60-69% mmHg and partial pressure of oxygen (pO2) \\>= 70 mmHg\n* Serum creatinine =\\\u003C 1.5 mg\u002FdL\n* Prior autologous HCT is permissible if relapse occurred \\> 3 months but =\\\u003C 6 months after HCT\n* Prior TBI-containing allogeneic HCT up to 3 Gy is permissible if \\> 6 months after HCT\n* A human leukocyte antigen (HLA)-matched or near-matched related, unrelated or haploidentical donor for collection of stimulated peripheral blood stem cells or HLA-matched or near-matched cord blood unit must be identified and readily available\n* Women of childbearing potential and men must agree to use adequate contraception beginning at the signing of the consent until at least 12 months post-transplant\n* Patients may have previously received chemotherapy with a mitoxantrone, idarubicin- or cladribine\u002Ffludarabine-based regimen for MDS or AML. If the patient has received CLAG-M or FLAG-Ida before and has been sensitive to this regimen, eligibility will be determined on a case-by-case basis by the study principal investigator (PI)\n* Ability to understand and sign a written informed consent document (or legal representative)\n* DONOR: Patients must have an HLA-matched related donor or an HLA-matched unrelated donor, or haploidentical donor who meets standard FHCC and\u002For National Marrow Donor Program (NMDP) or other donor center criteria for peripheral blood stem cell (PBSC) donation as follows:\n\n  * Related donor: related to the patient and genotypically or phenotypically identical for HLA-A, B, C, DRB1 and DQB1. Phenotypic identity must be confirmed by high-resolution typing\n  * Unrelated donor:\n\n    * Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; OR\n    * Mismatched for a single allele without antigen mismatching at HLA-A, B, or C as defined by high resolution typing but otherwise matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing\n    * Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment. The recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain panel reactive antibody (PRA) screens to class I and class II antigens for all patients before HCT. If the PRA shows \\> 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained. The donor should be excluded if any of the cytotoxic cross match assays are positive. For those patients with an HLA class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results. A positive anti-donor cytotoxic crossmatch is an absolute donor exclusion\n    * Patient and donor pairs homozygous at a mismatched allele in the graft rejection vector are considered a two-allele mismatch, i.e., the patient is A\\*0101 and the donor is A\\*0102, and this type of mismatch is not allowed\n* Haploidentical donor:\n\n  * Donors must be haploidentical relatives of the patients. Donor-recipient compatibility will be tested through HLA typing at high resolution for the HLA loci (-A, -B, -C, -DRB1, -DQB1). Donor and recipient should share at least 5\u002F10 HLA loci.\n  * Age ≥ 12 years\n  * Weight ≥ 40 kg.\n  * Ability of donors younger than 18 years of age to undergo apheresis without use of a vascular access device. Vein check must be performed and verified by an apheresis nurse prior to arrival.\n  * Donor must meet the selection criteria as defined by the Foundation of the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) guidelines.\n  * In case of more available haploidentical donors, selection criteria should include, in this order:\n\n    * For cytomegalovirus (CMV) seronegative recipients, a CMV seronegative donor\n    * Red Blood Cell compatibility\n\n      * i. RBC cross match compatible\n      * ii. Minor ABO incompatibility\n      * iii. Major ABO incompatibility\n\nExclusion Criteria:\n\n* Patients \\>= 18 years being treated at Seattle Children's Hospital\n* Active central nervous system (CNS) disease\n* Concomitant illness associated with a likely survival of \\\u003C 1 year\n* Active systemic fungal, bacterial, viral, or other infection, unless disease is under treatment with anti-microbials and\u002For controlled or stable. Patients with fever thought to be likely secondary to myeloid malignancy are eligible\n* Known hypersensitivity or contraindication to any study drug used in this trial\n* Pregnancy or lactation\n* Concurrent treatment with any other approved or investigational anti-leukemia agent\n* Haploidentical donor exclusion criteria:\n\n  * Since detection of anti-donor-specific antibodies (anti-DSA) is associated with higher graft rejection rate, patients will be screened for anti-DSA pre-transplant. Patient with DSA mean fluorescent intensity (MFI) \\\u003C5000 after desensitization treatment, will be considered eligible to participate in the study.",{"count":203,"type":20},[23],"This phase I trial studies the best dose of total body irradiation when given with cladribine, cytarabine, filgrastim, and mitoxantrone (CLAG-M) or idarubicin, fludarabine, cytarabine and filgrastim (FLAG-Ida) chemotherapy reduced-intensity conditioning regimen before stem cell transplant in treating patients with acute myeloid leukemia, myelodysplastic syndrome, or chronic myelomonocytic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Giving chemotherapy and total body irradiation before a donor peripheral blood stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When the healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets and may help destroy any remaining cancer cells. Sometimes the transplanted cells from a donor can attack the body's normal cells called graft versus host disease. Giving cyclophosphamide, cyclosporine, and mycophenolate mofetil after the transplant may stop this from happening.",[29,85,58,30,86,158,27,226,157],"Refractory Acute Leukemia of Ambiguous Lineage","2026-03-03",{"date":229,"type":35},"2026-03-05",{"date":231,"type":35},"2020-12-03",{"date":233,"type":20},"2027-03-17",{"name":143,"class":42},{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":21,"phases":243,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":96},"100360156","phase-1-pembrolizumab-and-decitabine-with-or-without-venetoclax-in-treating-patients-with-acute-myeloid-leukemia-or-myelodysplastic-syndrome-that-is-newly-diagnosed-recurrent-or-refractory-100360156","NCT03969446","Pembrolizumab and Decitabine With or Without Venetoclax in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome That Is Newly-Diagnosed, Recurrent, or Refractory","Phase 1b Study of Pembrolizumab, Decitabine +\u002F- Venetoclax Combination Therapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Agreement to allow the use of archival blood samples and marrow from diagnostic tumor biopsies. If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Eastern Cooperative Oncology Group (ECOG) status =\\\u003C 1\n* Histologically confirmed AML (not including acute promyelocytic leukemia) or MDS\n* Patients with the following diagnoses\n\n  * Refractory\u002Frelapsed AML by World Health Organization (WHO) classification, who are not candidates for allogeneic stem cell transplantation or potentially curative chemotherapy (Extramedullary disease is allowed).\n  * MDS by WHO Classification who have failed to respond or relapsed after previous therapies\n* Must have a life expectancy of \\>= 3 months\n* Fully recovered (=\\\u003C grade 1) from the acute toxic effects (except alopecia) or complications of prior anti-cancer therapy, including surgery\n* Cannot be a candidate for allogeneic hematopoietic cell transplantation (alloHCT) within 90 days of starting treatment on the protocol and should be off pembrolizumab for at least 30 days to become eligible for alloHCT post-protocol therapy\n* White blood cells (WBC) =\\\u003C 25 x 10\\^9\u002FL prior to initiation of venetoclax. Cytoreduction with hydroxyurea prior to treatment and\u002For during cycles 1 and\u002For 2 may be required\n* Total bilirubin =\\\u003C 2 x upper limit of normal (ULN) (unless has Gilbert's disease)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN\n* Creatinine clearance of \\> 30 mL\u002Fmin per 24-hour urine test or the Cockcroft-Gault formula\n* International normalized ratio (INR) OR prothrombin time (PT) =\\\u003C 1.5 x ULN\n* Activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN\n* Left ventricular ejection fraction (LVEF) \\>= 50%\n* Pulmonary function tests diffusion capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) \\> 50% predicted\n* Corrected QT (QTc) =\\\u003C 480 ms, Note: electrocardiogram (ECG) (single-read) to be performed within 14 days prior to day 1 of protocol therapy\n* Seronegative for human immunodeficiency virus (HIV) antigen (Ag)\u002Fantibody (Ab) combo, hepatitis C virus (HCV), and active hepatitis B virus (HBV) (surface antigen negative)\n\n  * If positive, hepatitis C ribonucleic acid (RNA) quantitation must be performed\n* Meets other institutional and federal requirements for infectious disease titer requirements\n\n  * Note: Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n* Agreement by males and females of childbearing potential to use an effective birth control method of low user dependency or abstain from heterosexual activity from 4 weeks prior to first dose of treatment throughout the study treatment period and 3 (males) to 4 (females) months from the last dose of treatment\n\n  * Childbearing potential is defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n* Also, male subjects should refrain from sperm donation from the start of treatment throughout the study treatment period and for 6 months following the last dose of treatment\n\nExclusion Criteria:\n\n* Previous allogeneic cell transplantation\n* Previous treatment with pembrolizumab\n* Previously refractory to treatment with decitabine + venetoclax (i.e. progressed through therapy without first attaining at least a partial response)\n* Systemic steroid therapy or any other form of immunosuppressive medication\n* Received a live-virus or live-attenuated virus vaccination within 30 days of planned treatment start. Administration of killed vaccines is allowed\n* Prior treatment with any other anti-programmed cell death protein-1 (anti-PD-1), or PD ligand-1 (PD-L1) or PD ligand-2 (PD-L2) agent or an antibody targeting other immuno-regulatory receptors or mechanisms\n* Prior therapy with an anti-CD137, anti-CTLA-4 antibody (including ipilimumab), denosumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways\n* Current or planned use of other investigational agents, antineoplastic, biological or chemotherapeutic agents during the study treatment period, or within 4 weeks or five half-lives, whichever is shorter, prior to day 1 of protocol therapy with the following exception:\n\n  * Hydroxyurea is allowed prior to treatment with venetoclax and through cycle 2 for control of rapidly progressing leukemia\n* Strong or moderate CYP3A4 inducers within 14 days prior to day 1 of venetoclax\n* Grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or star fruit consumed within 3 days prior to the first dose of venetoclax\n* Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=\\\u003C2 weeks of radiotherapy) to non-central nervous system (CNS) disease\n* Concurrent use of corticosteroids (exception: nasal or topical corticosteroids or physiologic levels for steroid replacement are allowed)\n* Granulocyte-macrophage colony-stimulating factor (GMCSF) or granulocyte colony stimulating factor (GCSF) within 7 days prior to start of study treatment\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)\n* Active central nervous system (CNS) disease\n* The following cardiac conditions:\n\n  * Unstable angina\n  * Congestive heart failure (New York Heart Association \\[NYHA\\] class III or IV; or class II with a recent decompensation requiring hospitalization or referral to a heart failure clinic within 6 months before screening)\n  * Acute coronary syndrome and\u002For revascularization (e.g., coronary artery bypass graft, stent) within 6 months of first dose of study drug Note: Allowed heart conditions are restricted to stable angina, arrhythmia or atrial fibrillation controlled by medication, history of controlled coronary artery disease \\> 6 months prior to screening and medically managed\n* Pulmonary dysfunction, such as history of non-infectious pneumonitis that required steroids or current pneumonitis or idiopathic pulmonary fibrosis. Note: Allowed pulmonary conditions are restricted to mild chronic obstructive pulmonary disease (COPD), controlled asthma, resolved bacterial or fungal pneumonia, or previous pulmonary embolism (PE) that has been compensated\n* Active autoimmune disease that has required systemic treatment in the past 2 years (replacement therapies for hormone deficiencies are allowed)\n* Uncontrolled active infection requiring therapy\n* Known history of active TB (Bacillus tuberculosis)\n* Symptomatic ascites or pleural effusion\n* Clinically significant uncontrolled illness\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":52,"type":20},[23],"This phase Ib trial studies the side effects and best dose of pembrolizumab and how well it works in combination with decitabine with or without venetoclax in treating patients with acute myeloid leukemia or myelodysplastic syndrome that is newly-diagnosed, has come back (recurrent), or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. This trial may help doctors find the best dose of pembrolizumab that can be safely given in combination with decitabine with or without venetoclax, and to determine what side effects are seen with this treatment.",[28,56,29,58,30,27],{"date":229,"type":35},{"date":248,"type":35},"2020-05-04",{"date":250,"type":20},"2027-07-04",{"name":194,"class":42},{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":16,"minAge":259,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":21,"phases":262,"briefSummary":263,"conditions":264,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":96},"100334179","phase-1-edetate-calcium-disodium-or-succimer-in-treating-patients-with-acute-myeloid-leukemia-or-myelodysplastic-syndrome-undergoing-chemotherapy-100334179","NCT03630991","Edetate Calcium Disodium or Succimer in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Chemotherapy","Monitoring, Detoxifying, and Rebalancing Metals During Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Therapy","Inclusion Criteria:\n\n* Patients ≥18 years of age, or their legally authorized representative (LAR), must have the ability to understand the requirements of the study and must voluntarily sign the informed consent form. For patients \\\u003C18 years of age, a parent or LAR must have the ability to understand the requirements of the study and must voluntarily sign the informed consent form. Any required verbal assent and\u002For signed assent of minor must be obtained for participants \\\u003C18 years.\n* Age ≥18 years at the time of signing the informed consent form.\n* Age ≥1 years and \\\u003C18 years with weight requirement ≥8 kg at the time of the signing of the informed consent form (e.g. by parent or LAR)\n* Patients enrolling in the pediatric\u002Fadolescent\u002Fyoung adult exploratory cohort must be:\n\nAge ≥ 1 years and \\\u003C18 years with weight requirement ≥8 kg at the time of the signing of the informed consent form (e.g. by parent or LAR), Or age 18 years -39 years at the time of the signing of the informed consent form\n\n* Diagnosis of any of the following:\n* Newly diagnosed (or untreated) AML with intermediate-risk\u002Fpoor-risk cytogenetics, intermediate-risk\u002Fpoor-risk molecular, or secondary AML (i.e. therapy-related or evolved from antecedent hematologic malignancy)\n* Newly diagnosed (or untreated) myeloid blast phase of myeloproliferative neoplasm (MPN) (including myeloid blast phase of chronic myeloid leukemia \\[CML\\])\n* Newly diagnosed (or untreated) high-risk, very-high risk or secondary MDS\u002Fmyeloid neoplasm\n* Newly diagnosed (or untreated) MDS\u002FMPN (regardless of cytogenetic\u002Fmolecular status)\n* Relapsed and\u002For refractory AML, MDS\u002Fmyeloid neoplasm , MDS\u002FMPN, myeloid blast phase of MPN (including myeloid blast phase of CML)\n* Patients enrolling in the childhood\u002Fadolescent\u002Fyoung adult exploratory cohort may have any of the following diagnoses:\n* High-risk or relapsed\u002Frefractory childhood, adolescent, or young adult malignancies including but not limited to high-risk or relapsed\u002Frefractory ALL or other high-risk or relapsed refractory malignancies\n* This includes, but is not limited to, the following: High-risk ALL\u002FLL including T-ALL\u002FLL, Ph-like ALL\u002FLL, Ph+ B-ALL\u002FLL, B-ALL\u002FLL with CNS lymphoid leukemic involvement, testicular involvement, other extramedullary involvement by ALL\u002FLL; ALL\u002FLL with any of the NCI high-risk features: patients aged 10 years or older and those with a white blood cell count ≥50 × 109 per L), high-risk cytogenetics (MLL rearrangements, near haploidy \\[\\\u003C30 chromosomes\\], low hypodiploidy \\[30-39 chromosomes\\], t\\[17;19\\]\\[q23;p13\\], intrachromosomal amplification of chromosome 21), Burkitts'; Burkitt's-like, Double-Hitt; CNS involvement by any non-primary brain malignancy; Metastatic disease of any malignancy; 5-year survival prognosis of less than 50%, based on the treating physician's assessment\n* Patients on non-investigational regimens or on IND-exempt MD Anderson studies (for hematologic malignancies) of approved drugs are also eligible.\n* Patients on IND studies (for hematologic malignancies) utilizing FDA approved commercially available drugs are eligible.\n* Investigational agents that are not used for treatment of the leukemia per se (e.g. anti-infective prophylaxis or therapy) will be allowed. Other supportive care studies are allowed, even if under an IND.\n* Newly diagnosed MDS or AML, as well as MDS\u002FMPN, myeloid blast phase of MPN (including myeloid blast phase of CML), patients can enroll on this study after start of non-investigational induction therapy, but must be within first 3 cycles of therapy of front-line therapy. Patients with relapsed and\u002For refractory AML, MDS, MDS\u002FMPN, myeloid blast phase of MPN (including myeloid blast phase of CML) can enroll. Newly diagnosed patients enrolling in the exploratory cohort with high-risk malignancies can enroll after the start of non-investigational therapy but must be within first 3 cycles of front-line therapy.\n* Transformed and untreated AML transformed from previously treated MDS, myeloproliferative neoplasm (MPN) or other types of secondary AML are allowed. Myeloid-Blast Phase of MPN and Chronic Myeloid Leukemia (CML) are allowed.\n* Eastern Cooperative Oncology Group (ECOG) performance status of =\\\u003C 3 or Lansky or Karnofsky ≥ 30 at study entry; patients who are unable to walk, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n* Laboratory test results within these ranges (unless due to leukemia or other hematologic malignancy):\n* Serum creatinine =\\\u003C 1.5 mg\u002FdL\n* Total Bilirubin =\\\u003C 2.0 x upper limit of normal (ULN), unless the patient has Gilbert's\n* AST (SGOT) and\u002For ALT (SGPT) =\\\u003C 2.0 x ULN\n* Women of childbearing potential (WCBP) must have a negative urine pregnancy test within 7 days and must either commit to continued abstinence from heterosexual intercourse or adopting at least one highly effective method of contraception. These methods include intra-uterine device, tubal ligation, partner's vasectomy, and hormonal birth control pills. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential\n* Extramedullary disease is allowed as long as it can be measured and followed for response.\n\nNote: Patients can be considered MDS by either WHO or FAB150 criteria Note: MDS risk status assessment is based on IPSS-R and\u002For IPSS-M. AML risk status assessment is based on ELN and World Health Organization classification\n\nExclusion Criteria:\n\n* Nursing and pregnant females. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\n* Uncontrolled inter-current illness including, but not limited to, uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or which judged by the investigator, places the patient at unacceptable risk\n* Acute Promyelocytic leukemia (APL)","1 Year",{"count":261,"type":20},58,[23],"This phase I trial studies the side effects and best dose of edetate calcium disodium or succimer in treating patients with acute myeloid leukemia or myelodysplastic syndrome undergoing chemotherapy. Edetate calcium disodium or succimer may help to lower the level of metals found in the bone marrow and blood and may help to control the disease and\u002For improve response to chemotherapy.",[28,265,266,267,268,56,269,270,29,271,58,272,30,273,27,159,274,275],"Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome","Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Chronic Myelogenous Leukemia, BCR-ABL1 Positive","High Risk Myelodysplastic Syndrome","Myelodysplastic\u002FMyeloproliferative Neoplasm","Myeloproliferative Neoplasm","Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Recurrent Myelodysplastic\u002FMyeloproliferative Neoplasm","Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Secondary Myelodysplastic Syndrome","Very High Risk Myelodysplastic Syndrome","2026-02-26",{"date":278,"type":35},"2026-03-02",{"date":280,"type":35},"2018-10-11",{"date":282,"type":20},"2027-04-30",{"name":95,"class":42},{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":21,"phases":293,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":43},"100570866","phase-1-q702-for-the-treatment-of-patients-with-hematologic-malignancies-100570866","NCT06712810","Q702 for the Treatment of Patients With Hematologic Malignancies","MC220806: Phase I Study Evaluating the Efficacy of CSF1R and TAM Receptor or Inhibition in Hematologic Malignancies With Q702, a Small Molecular Inhibitor","Inclusion Criteria:\n\n* PRE-REGISTRATION: Age ≥ 18 years\n* PRE-REGISTRATION: Not eligible for or have failed therapies with established benefits, at the discretion of the treating physician\n* PRE-REGISTRATION: Patients must meet one of the following criteria:\n\n  * Relapsed\u002Frefractory patients with Erdheim-Chester disease, Langerhans histiocytosis, histiocytic sarcoma, or other malignant histiocytosis without activating alterations in v-Raf murine sarcoma viral oncogene homolog B (BRAF) or Mitogen-activated protein kinase kinase (MAP2K) oncogenes who have progressed after first line of therapy.\n\n    * Note: Relapsed is defined as a relapse that occurred after having a response to the last therapy at any point during the treatment. Refractory is no response (stable disease or progressive disease while on therapy) to a given treatment at least after 1 month of being on the given treatment.\n  * Newly diagnosed patients with Rosai-Dorfman disease without activating alterations in MAP2K oncogenes.\n  * Relapsed\u002Frefractory patients with Rosai-Dorfman disease and an activating mitogen-activated protein kinase (MAPK) pathway alteration who have failed prior treatment with cobimetinib.\n  * Relapsed\u002Frefractory patients with Erdheim-Chester disease or Langerhans histiocytosis who have received vemurafenib for BRAF V600E mutated disease or cobimetinib for disease with activating MAP2K alterations.\n  * Patients with Erdheim-Chester disease, Rosai-Dorfman disease, Langerhans histiocytosis, histiocytic sarcoma, or another malignant histiocytosis who cannot tolerate or have a contraindication to BRAF or MEK inhibitors or those who cannot have reliable access to these inhibitors due to financial restraints or geographic location or initiation of BRAF or mitogen-activated protein kinase kinase (MEK) inhibitors is futile based on the genomic alterations or the discretion of treating physician.\n  * Relapsed\u002Frefractory higher risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) or myelofibrosis (MF).\n\n    * Note: MF patients must have failed ≥ 1 of the 4 Food and Drug Administration (FDA)-approved Janus kinase (JAK) Inhibitors for MF (i.e. ruxolitinib, fedratinib, pacritinib, momelotinib) to be eligible. MDS and CMML patients must have failed hypomethylating agent-based therapy, if eligible.\n    * Note: Higher risk is defined as intermediate or higher risk by international prognostic scoring system (IPSS-R) or moderate high or higher risk as per molecular internal prognostic scoring system (IPSS-M).\n  * T cell lymphoma (peripheral and cutaneous), or mantle cell lymphomas. Patients must have failed ≥ 2 lines of therapy.\n  * Primary central nervous system (CNS) lymphoma who has failed ≥ 2 lines of therapy.\n  * Relapsed or refractory follicular lymphoma; or Waldenstrom macroglobulinemia\u002Flymphoplasmacytic lymphoma. Must have failed ≥ 2 lines of therapy.\n  * Patients with Waldenström macroglobulinemia who have received or are not eligible for a Bruton tyrosine kinase (BTK)-inhibitor therapy.\n  * Relapsed or refractory chronic lymphocytic leukemia (CLL)\u002Fsmall lymphocytic lymphoma (SLL) who have failed ≥ 2 lines of therapy and have been treated with at least one prior line of a BTK inhibitor and\u002For a B-cell lymphoma 2 (BCL2) inhibitor. Need documented CLL\u002FSLL requiring treatment according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines 2018.\n\n    * NOTE: Use of oral steroids up to 20 mg of daily will be allowed for patients who are discontinuing BTK inhibitors just prior to the registration. This is not mandatory and should be done at the discretion of patient's treating physician.\n\n      * Note: All patients in the above disease groups may be on corticosteroids at the investigator's discretion\n* PRE-REGISTRATION: Histopathological or cytological confirmation of diseases\n* PRE-REGISTRATION: Willingness to provide mandatory blood, bone marrow aspirate, saliva, and tissue specimens for correlative research, as applicable to the disease site\n* PRE-REGISTRATION: Ability to swallow pills\n* REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2\n* REGISTRATION: Life expectancy of ≥ 3 months\n* REGISTRATION: Measurable or assessable disease:\n\n  * For histiocytic neoplasms and lymphoma-measurable disease is defined as measurable by CT (dedicated CT or the CT portion of a PET\u002FCT) or MRI: To be considered measurable, there must be at least one lesion that has a single diameter of ≥ 1.5 cm for non-CNS disease. For CNS involved disease, MRI confirmation with any size would be appropriate.\n\n    * NOTE: Skin lesions can be used if the area is ≥ 1.5 cm in at least one diameter and photographed with a ruler. Patients with assessable disease by PET\u002FCT are also eligible as long as the assessable disease is biopsy proven lymphoma or histiocytic\u002Fdendritic cell neoplasms.\n  * For all other eligible diseases listed-N\u002FA\n* REGISTRATION: Hemoglobin ≥ 8.0 g\u002FdL (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Absolute neutrophil count (ANC) ≥ 1.0 x 10\\^9\u002FL (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Platelet count ≥ 80 x 10\\^9\u002FL (obtained ≤ 14 days prior to registration)\n* REGISTRATION: White blood cell (WBC) ≥ 2.5 x 10\\^9\u002FL (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Alanine aminotransferase (ALT), aspartate transaminase (AST), and alkaline phosphatase (ALP) ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Serum creatinine of ≤ 1.5 x ULN and calculated creatinine clearance of ≥ 50 mL\u002Fmin using the Cockcroft-Gault formula (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Negative urine or serum pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only\n* REGISTRATION: Sexually active patients and their partners must use an effective method of contraception associated with a low failure rate prior to study entry and for the duration of study participation and for at least 3 months after the last dose of study drug.\n\n  * Note: The following are considered effective contraceptives: oral contraceptive pill; condom plus spermicide; diaphragm plus spermicide; patient or partner surgically sterile; patient or partner more than 2 years postmenopausal; or injectable or implantable agent\u002Fdevice\n* REGISTRATION: Provide written informed consent\n* REGISTRATION: Ability to complete questionnaire(s) by themselves or with assistance\n* REGISTRATION: Willing to return to the enrolling institution for follow-up (during the Active Monitoring Phase of the study).\n\nExclusion Criteria:\n\n* PRE-REGISTRATION: Myeloproliferative neoplasm (MPN) patients with known active CNS metastases and\u002For carcinomatous meningitis.\n\n  * Note: Histiocytosis and lymphoma patients who are on steroids are allowed to enroll\n* REGISTRATION: Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effect on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception\n* REGISTRATION: New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary\u002Fperipheral artery bypass graft, congestive heart failure ≤ 6 months prior to registration\n* REGISTRATION: Corrected QT interval (using Fridericia's correction formula) (QTcF) of \\> 470 msec\n* REGISTRATION: Known active infection with human immunodeficiency virus (HIV), Human T-lymphotropic virus 1 (HTLV-1), hepatitis B virus (HBV), or hepatitis C virus (HCV):\n\n  * Active infection with (HIV) and CD4+ T-cell count \\\u003C 350 μL.\n  * Patients with a detectable HIV viral load and not on antiretroviral therapy (ART) for ≥ 4 weeks.\n  * Exceptions:\n\n    * Patients with a history of hepatitis B or C are allowed if HBV deoxyribonucleic acid (DNA) or HCV ribonucleic acid (RNA) are undetectable.\n    * Patients with active HIV infection and CD4+ T-cell count ≥ 350 μL who are on active antiretroviral treatment\n* REGISTRATION: Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy\n* REGISTRATION: Concomitant use of strong inhibitors and inducers of CYP1A2, CYP2C19, CYP2D6, and strong inhibitors and inducers of CYP3A4 within five half-lives of the active drug prior to registration and throughout the trial.\n\n  * Note: Strong inhibitors and inducers of CYP3A4 should be discontinued for five half-lives of the active drug prior to starting study drug and avoided throughout the trial\n* REGISTRATION: Concomitant use of any herbal supplements.\n\n  * Note: Supplements taken prior to starting study drug should be discussed with the Principal Investigator as varied washout periods may be clinically indicated and necessary\n* REGISTRATION: Any of the following prior therapies used as primary cancer treatment:\n\n  * Targeted therapeutics other than monoclonal antibodies (e.g., kinases inhibitors) ≤ 2 weeks prior to registration.\n  * Monoclonal antibodies ≤ 6 weeks, or ≥ 5 half-life, whichever is shorter, prior to registration.\n  * Chemotherapy ≤ 4 weeks prior to registration (6 weeks for nitrosoureas or Mitomycin C.\n  * Surgery ≤ 4 weeks prior to registration\n  * Any investigational therapy ≤ 4 weeks prior to registration\n  * Radiation therapy ≤ 4 weeks prior to registration\n\n    * Exceptions:\n\n      * Palliative radiation therapy ≥ 2 weeks prior to registration for control of tumor mass related symptoms (e.g., pain control from a discrete bone metastasis) allowed, unless the radiation field includes organs for which the radiation therapy could result in certain direct organ toxicities (e.g., radiation induced esophagitis), which could complicate the interpretation of the Q702 safety profile.\n      * Radiation induced toxicities which could interfere with the interpretation of the Q702 safety profile should recover to ≤ grade 1 before registration.\n      * Patients receiving palliative radiation intended to reduce the risk of a potential pathological fracture should be allowed ≥ 4 weeks from the last radiation therapy treatment to recover from any radiation induced toxicity and to allow for an adequate period of observation relative to the potential risk of a pathological fracture\n* REGISTRATION: Failure to recover from acute, reversible effects of prior therapy to ≤ grade 1 or patient baseline prior to registration.\n\n  * NOTE: Patient with chronic effects such as neuropathy, fatigue, keratitis\u002Fkeratopathy, anorexia, etc. are allowed\n* REGISTRATION: Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* REGISTRATION: Active retinal pigment epithelium (RPE)\u002Fphotoreceptor disorders such as retinitis pigmentosa, cone-rod dystrophies, Bests dystrophy, Stargardt disease (STGD), macular degeneration, retinal detachment, and opaque cornea. Exceptions:\n\n  * Mild blurry vision, either age-related or due to ocular or systemic disorder (e.g., diabetes, dry eyes, cataracts, uncorrected refraction abnormality) may be allowed at the discretion of the ophthalmologist if deemed as not constituting evidence of pre-existing retinopathy (e.g., severe nonproliferative or proliferative diabetes retinopathy) or a condition with the potential to cause a predisposition to drug-induced retinopathy. \\[e.g., severe retinal vascular disease with scattered intraretinal hemorrhages, cotton wool-spots and intraretinal microvascular abnormalities (IRMA)\\]\n  * Patients with only one assessable eye and no evidence of pre-existing retinopathy may be allowed at the discretion of the principal investigator\n* REGISTRATION: Active second malignancy requiring treatment that would interfere with the assessment of the response of the primary cancer or interpretation of the safety of this protocol therapy",{"count":292,"type":20},46,[23],"This phase I trial tests the safety, side effects, and best dose of Q702 in treating patients with hematologic malignancies. Q702 is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. Giving Q702 may be safe, tolerable and\u002For effective in treating patients with hematologic malignancies.",[296,297,298,299,300,301,85,302,303,304,58,305,306,307,308,86,309,310,311,312,27,313,314,315,316,317,118,318,319,320,321,322,119,323,324,325,326],"Hematopoietic and Lymphatic System Neoplasm","Histiocytic Sarcoma","Malignant Histiocytosis","Peripheral T-Cell Lymphoma, Not Otherwise Specified","Primary Cutaneous T-Cell Non-Hodgkin Lymphoma","Recurrent Chronic Lymphocytic Leukemia","Recurrent Follicular Lymphoma","Recurrent Langerhans Cell Histiocytosis","Recurrent Lymphoplasmacytic Lymphoma","Recurrent Myelofibrosis","Recurrent Small Lymphocytic Lymphoma","Recurrent Waldenstrom Macroglobulinemia","Refractory Chronic Lymphocytic Leukemia","Refractory Erdheim-Chester Disease","Refractory Follicular Lymphoma","Refractory Langerhans Cell Histiocytosis","Refractory Lymphoplasmacytic Lymphoma","Refractory Myelofibrosis","Refractory Small Lymphocytic Lymphoma","Refractory Waldenstrom Macroglobulinemia","Rosai-Dorfman-Destombes Disease","Primary Central Nervous System Lymphoma","Recurrent Erdheim-Chester Disease","Recurrent Fibroblastic Reticular Cell Sarcoma","Recurrent Histiocytic Sarcoma","Recurrent Interdigitating Dendritic Cell Sarcoma","Recurrent Rosai-Dorfman-Destombes Disease","Refractory Fibroblastic Reticular Cell Sarcoma","Refractory Histiocytic Sarcoma","Refractory Interdigitating Dendritic Cell Sarcoma","Refractory Rosai-Dorfman-Destombes Disease","2025-10-08",{"date":329,"type":35},"2025-10-10",{"date":331,"type":35},"2025-08-27",{"date":333,"type":20},"2030-09-15",{"name":335,"class":42},"Mayo Clinic"]