[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-secondary-acute-myeloid-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-secondary-acute-myeloid-leukemia":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"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":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"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",false,"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)","ALL","18 Years",{"count":19,"type":20},35,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","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.",[26,27,28,29,30,31,32,33,34,35,36],"Acute Myeloid Leukemia With Complex Karyotype","Myelodysplastic Chronic Myelomonocytic Leukemia","Myelodysplastic Syndrome","Recurrent Acute Myeloid Leukemia","Recurrent Myelodysplastic Chronic Myelomonocytic Leukemia","Recurrent Myelodysplastic Syndrome","Recurrent Secondary Acute Myeloid Leukemia","Refractory Acute Myeloid Leukemia","Refractory Myelodysplastic Chronic Myelomonocytic Leukemia","Refractory Myelodysplastic Syndrome","Refractory Secondary Acute Myeloid Leukemia","NOT_YET_RECRUITING","2026-05-06",{"date":40,"type":41},"2026-05-12","ACTUAL",{"date":43,"type":20},"2027-04-05",{"date":45,"type":20},"2029-04-05",{"name":47,"class":48},"City of Hope Medical Center","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100352836","phase-1-ruxolitinib-in-combination-with-venetoclax-with-and-without-azacitidine-in-treating-patients-with-relapsed-or-refractory-acute-myeloid-leukemia-100352836","NCT03874052","Ruxolitinib in Combination With Venetoclax With and Without Azacitidine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia","Phase I Study to Evaluate Safety of Ruxolitinib in Combination With Azacitidine + Venetoclax in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Ability to understand and the willingness to sign a written informed consent document\n* Age \\>= 18 years at time of informed consent. Persons of all genders and gender identities, and members of all races and ethnic groups will be included\n* Morphologically documented relapsed\u002Frefractory (R\u002FR) AML or R\u002FR secondary AML (sAML) that has progressed after at least 1 prior therapy for AML\n\n  * Prior treatment with venetoclax and azacitidine is allowed\n  * Treatment with hydroxyurea will not be considered a line of therapy\n  * Patients with morphologically documented myelodysplastic syndrome (MDS) that has progressed on hypomethylating agent (HMA) therapy also will be considered if the patient is ineligible for induction with intensive chemotherapy (IC), defined for this study as meeting one or more of the following criteria:\n\n    * Severe cardiac disorder (e.g., congestive heart failure requiring treatment, left ventricular ejection fraction (LVEF) of ≤ 50%, or chronic stable angina)\n    * Severe pulmonary disorder, certified by the managing physician\n    * Creatinine clearance of \\\u003C 45 ml\u002Fmin or\n    * Hepatic disorder with total bilirubin \\> 1.5 x upper limit of normal (ULN)\n    * Eastern Cooperative Oncology Group (ECOG) equal to 2\n    * Other comorbidity(ies) judged to be incompatible with high dose chemotherapy by the managing physician will be considered, at the discretion of the principal investigator (PI)\n* ECOG performance status 0 to 2\n* Persons of childbearing potential (PCBP) must have a negative serum or urine pregnancy test within 14 days prior to start of study drug administration\n* Patients must agree to use an adequate method of contraception while on study treatment and for 120 days after the last dose of ruxolitinib for Arm 1 and 6 months after the last dose of azacitidine for Arm 2\n* Must be able to take and absorb oral medications\n* Creatinine clearance ≥ 30 mL\u002Fmin; calculated by the Cockcroft Gault formula or measured by 24 hour urine collection\n* Total serum bilirubin ≤ 1.5 x ULN unless thought to be due to leukemic involvement\n* Serum aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) ≤ 3.0 x ULN unless thought to be due to leukemic involvement\n\nExclusion Criteria:\n\n* Diagnosis of acute promyelocytic leukemia (APL or AML M3 subtype)\n* Active central nervous system involvement with AML\n* Chemotherapy or therapy with a non-investigational agent other than a biologic intended to within 1 week of the planned start of study therapy, with the exception of hydroxyurea for cytoreduction of proliferative disease, or at the discretion of the principal investigator (PI)\n* Therapy with a non-biologic investigational agent within 14 days or 5 half lives, whichever is longer, of the planned start of study therapy, or for the period recommended by the institution's research pharmacy service, or at the discretion of the PI\n* Therapy with a biologic investigational or non-investigational agent (e.g., monoclonal antibody) within 30 days of the planned start of study therapy, or for the period recommended by the institution's research pharmacy service, or at the discretion of the PI\n* Concurrent active malignancy with expected survival of less than 1 year, at the discretion of the investigator. For example, candidates with treated skin cancers, prostate cancer, breast cancer, etc. without metastatic disease are candidates for therapy since their expected survival exceeds that of relapsed or refractory AML\n* Clinically significant graft versus host disease (GVHD) or active GVHD requiring initiation or escalation of treatment within 28-day screening period\n* Participants with rapidly progressive disease (defined by blast count doubles within 48 hours) or organ dysfunction\n* Documented cardiac insufficiency (e.g., symptomatic heart failure, left ventricular ejection fraction of ≤ 40%)\n* Symptomatic shortness of breath or patient requires supplemental oxygen support\n* Clinically significant coagulation abnormality, such as disseminated intravascular coagulation\n* Known history of cerebrovascular accident, myocardial infarction, or intracranial hemorrhage within 2 months of enrollment\n* Known clinically significant liver disease defined as ongoing drug-induced liver injury, chronic active hepatitis C (hepatitis C virus \\[HCV\\]), chronic active hepatitis B (hepatitis B virus \\[HBV\\]), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, portal hypertension, or history of autoimmune hepatitis\n* Untreated HIV or active hepatitis C detectable by polymerase chain reaction (PCR), or chronic hepatitis B (patients positive for hepatitis B core antibody who are receiving intravenous immunoglobulin therapy \\[IVIG\\] are eligible if hepatitis B \\[HepB\\] PCR is negative)\n* Per PI discretion, active infection that is not well controlled by antibacterial or antiviral therapy\n\n  \\*Patients with a known history of tuberculosis (TB; Mycobacterium tuberculosis) are not eligible for participation. At investigator discretion, latent TB test should be performed for individuals considered to be at high-risk (e.g., immune compromised, persons that have traveled to, or emigrated from, regions with high rates of TB)\n* Clinically significant surgery within 2 weeks of enrollment\n* Unwillingness to receive infusion of blood products\n* Requires use of medications interact with study drug and that cannot be terminated or adjusted. Use of the following therapies requires review by the sponsor investigator:\n\n  * Strong and moderate CYP3A inhibitors\n  * Strong and Moderate CYP3A inducers\n* Patients with uncontrolled white blood cell count (defined as \\> 50 K\u002Fmm\\^3 and not controlled with hydroxyurea)\n* Patients with known sensitivity to ruxolitinib, venetoclax, or azacitidine\n* Since it is unknown whether ruxolitinib, venetoclax, or azacitidine (or their metabolites) are excreted in human milk and because of the potential for serious adverse reactions in the nursing infant, breastfeeding concurrent with study participation is prohibited",{"count":58,"type":20},51,[60],"PHASE1","This phase I trial studies the side effects and best dose of ruxolitinib when given together with venetoclax and compares the effect of ruxolitinib in combination with venetoclax to venetoclax and azacitidine in treating patients with acute myeloid leukemia (AML) that has come back (relapsed) or has not responded to treatment (refractory). Ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Azacitidine stops cells from making deoxyribonucleic acid and may kill cancer cells. It is a type of antimetabolite. 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 ruxolitinib in combination with venetoclax and azacitidine may be safe, tolerable, and\u002For effective compare to ruxolitinib with venetoclax in treating patients with relapsed or refractory AML.",[63,29,32,33,36],"Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome","RECRUITING","2026-03-20",{"date":67,"type":41},"2026-03-24",{"date":69,"type":41},"2019-08-16",{"date":71,"type":20},"2027-12-31",{"name":73,"class":48},"Jennifer Saultz",3]