[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-leukemia":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,50,81,110,137,162,188,215,238],{"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":25,"conditions":26,"keywords":35,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":49},"100620325","phase-1-a-study-of-revumenib-and-mezigdomide-in-people-with-leukemia-100620325",false,"NCT07356154","A Study of Revumenib and Mezigdomide in People With Leukemia","A Phase 1\u002F2 Study of the Menin Inhibitor Revumenib With the CELMod Mezigdomide in Relapsed\u002FRefractory KMT2A-rearanged, NPM1-mutant, and NUP98-rearranged Acute Leukemias","Inclusion Criteria:\n\n* Participant must be ≥ 12 years of age at the time of signing the informed consent form (ICF).\n* Participant must weigh at least 40 kg\n* Participant is willing and able to adhere to the study visit schedule and other protocol requirements.\n* Participant has relapsed\u002Frefractory acute leukemia defined acute myeloid leukemia, acute lymphoblastic leukemia, or mixed phenotype acute leukemia after as failure of at least 1 prior line of therapy (can be either primary refractory disease or progression during or after treatment)\n* Participant has confirmed acute leukemia with detectable NPM1c, KMT2A translocation, or NUP98 translocation.\n\n  1. At MSK, NPM1 testing utilizes MSK-REACT, a rapid multi-gene NGS panel used in all new AML diagnoses that is clinically validated by the Laboratory of Diagnostic Molecular Pathology pursuant to the requirements of CLIA'88 and approved by New York State, or MSK-IMPACT, a multi-gene NGS panel, which is authorized by the FDA. At non-MSK sites, NPM1 testing may be performed in local CLIA-certified laboratories using validated clinical assays with capable of detecting NPM1c variants at a frequency of ≥5%. Eligible patients must have an NPM1c (nucleophosmin) exon 12 variant as determined by these assays.\n  2. At MSK, KMT2A and NUP98 testing will utilize chromosomal analysis and fluorescence in situ hybridization studies. At non-MSK sites, testing may be performed in local CLIA-certified laboratories using validated clinical assays with performance characteristics sufficient to detect relevant translocations. Eligible patients must have a KMT2A or NUP98 translocation as determined by these assays\n  3. The patient's chart will be utilized for screening purposes\n* Regarding prior treatment with a menin inhibitor:\n\n  1. Participants enrolled in Phase 1 have no requirements regarding prior treatment with a menin inhibitor\n  2. Participants enrolled in Phase 2, cohort 1, are required to be menin inhibitor naïve (no previous treatment with a menin inhibitor)\n  3. Participants enrolled in Phase 2, cohort 2, are required to be menin inhibitor exposed (previous treatment received a menin inhibitor)\n* Regarding prior alloSCT, at 60 days must have elapsed from day of transplant and at least 4 weeks must have elapsed from first dose of donor lymphocyte infusion.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score 0-2 (if aged ≥18 years); Karnofsky Performance Scale of ≥50 (if aged ≥16 years and \\\u003C18 years); Lansky Performance Score of ≥50 (if aged \\\u003C16 years).\n* Participant must have a WBC count \\\u003C25,000\u002FμL at the time of initiation of study drug (leukapheresis may be performed and\u002For hydroxyurea may be administered to decrease the WBC count to \\\u003C25,000\u002FμL).\n* Participant has adequate organ function defined as:\n\n  1. Serum aspartate aminotransferase\u002Fserum glutamic oxaloacetic transaminase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) ≤ 3 x ULN, unless considered due to leukemic organ involvement.\n  2. Serum total bilirubin \\\u003C 1.5 x ULN. Higher levels are acceptable if these can be attributed to ineffective erythropoiesis, leukemia organ involvement or Gilbert's syndrome.\n  3. Serum creatinine \\\u003C 2 x ULN or estimated glomerular filtration rate 60 mL\u002Fmin or greater based on local institutional practice for age-appropriate determination (e.g, Schwartz formula for pediatric patients or Cockcroft Gault formula for adults).\n  4. Adequate cardiac function defined as ejection fraction of ≥ 50% by echocardiogram or multigated acquisition scan.\n\nExclusion Criteria:\n\n* Participants with acute promyelocytic leukemia\n* Participants with isolated myeloid sarcoma\n* Participants who have previously received mezigdomide.\n* Participants with immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, disseminated intravascular coagulation, or uncontrolled tumor lysis syndrome.\n* Participant has presence of any other condition that may increase the risk associated with study participation, and in the opinion of the treating investigator, would make the patient inappropriate for entry into the study.\n* Participants with concurrent other malignancy that will confound interpretation of study endpoints.\n* Participants who have received other anti-leukemia therapy within 5 half-lives of the agent or 14 days, whichever is sooner, prior to study treatment and if toxicity related to said agent has not resolved; exceptions of acceptable concomitant therapies are listed below\n\n  1. Concomitant cytoreductive therapy in the form of hydroxyurea, corticosteroids, or cytarabine is permitted.\n  2. Concomitant therapy in the form of intrathecal chemotherapy for CNS treatment, is permitted.\n  3. Radiation therapy is not permitted except for localized palliative radiation to focal lesions after discussion with the Medical Monitor for patients who have progressed but remain on the study due to perceived clinical benefit per Investigator assessment\n* Participants with active graft versus host disease (GVHD) of grade 2 or higher requiring systemic treatment. Skin GVHD solely managed with topical corticosteroids would not be exclusionary.\n* Participant has significant active cardiac disease within 6 months prior to start of study treatment, including New York Heart Association (NYHA) class III or IV congestive heart failure; acute coronary syndrome (ACS); and\u002For stroke.\n* Participant has QTc interval (i.e., Fridericia's correction \\[QTcF\\]) ≥ 450 ms (mean of triplicate ECG) or other factors that increase the risk of QT prolongation or ventricular arrhythmic events (e.g., family history of long QT interval syndrome). Patients with a QTcF over 450 ms due to a bundle branch block or a pacemaker may participate in the study with approval of the study principal investigator.\n* Participant has active viral infection with human immunodeficiency virus (HIV), or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)\n* Participant is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.\n* Participant 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* Participant with active use of strong or moderate CYP3A4 inhibitors or strong CYP3A4 inducers. Details reviewed in Appendix B.\n* Participant with use of proton pump inhibitors less than 2 weeks prior to initiating treatment\n* Female participant who is pregnant or lactating. Male or female participants not willing to comply with contraceptive requirements, which include 4 months of contraception after last dose of revumenib for males and 6 months for females. Additional contraception details reviewed in Appendix D.","ALL","12 Years",{"count":19,"type":20},52,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The purpose of this study is to find out whether the combination of mezigdomide and revumenib is a safe treatment for people with relapsed or refractory KMT2A-r, NUP98-r, and NPM1-m acute leukemias.",[27,28,29,30,31,32,33,34],"Leukemia","Acute Leukemia","Relapse Leukemia","Refractory Leukemia","Refractory Acute Leukemia","Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","Mixed Phenotype Acute Leukemia",[27,28,29,30,31,32,33,34,36,37],"Memorial Sloan Kettering Cancer Center","25-229","RECRUITING","2026-06-18",{"date":41,"type":42},"2026-06-22","ACTUAL",{"date":44,"type":42},"2026-01-16",{"date":46,"type":20},"2029-01-16",{"name":36,"class":48},"OTHER",10,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100626713","phase-1-assessing-pi3k-gamma-inhibition-with-azacitidine-venetoclax-and-eganelisib-in-patients-with-acute-myeloid-leukemia-100626713","NCT07439211","Assessing PI3K Gamma Inhibition With Azacitidine, Venetoclax and Eganelisib in Patients With Acute Myeloid Leukemia","Safety of Targeting PI3Kgamma Signaling With Azacitidine, Venetoclax and Eganelisib in Acute Myeloid Leukemia: A Phase 1 Study (GAVEL)","GAVEL","Inclusion Criteria:\n\n* Subjects must have histologically confirmed AML that meets one of these categories of disease:\n\n  * Group A: Relapsed or Refractory: Subjects with relapsed or refractory AML or relapsed\u002Frefractory AML, who are not recommended for any approved targeted therapy must meet any one of the following criteria: (1) morphologic relapse (at least 5% blasts), or (2) refractory to intensive chemotherapy (at least one cycle of cytarabine and anthracycline-based intensive regimen) or at least 2 cycles of prior HMA\u002Fvenetoclax-based therapy (without CR\u002FCRh\u002FCRi). No limit to prior lines of AML therapy. OR\n  * (Expansion only) Group B: Untreated AML with ELN 2022 adverse risk disease: Subjects with newly diagnosed or previously untreated AML must be ineligible for intensive chemotherapy based on Ferrara criteria (age ≥75 years or presence of co- morbidity).\n* Evidence of marrow involved AML.\n* Age 18-90 years. Because no dosing or adverse event data are currently available on the use of eganelisib in participants \\\u003C18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.\n* Eastern Cooperative Oncology Group performance status ≤ 3 if 18 to 74 years of age or ECOG 0-2 if ≥ 75 years of age.\n* Subjects must meet the following organ and marrow function as defined below:\n\n  * total serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) or\n\n    ≤ 3 x ULN in case of Gilbert's disease\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 x × institutional ULN\n  * Creatinine clearance (CrCl) ≥ 30 L\u002Fmin (Cockcroft-Gault formula)\n* Prior history of CNS leukemia that has been treated, asymptomatic and controlled are eligible. CNS evaluation is not required for screening if asymptomatic.\n* Subjects with a prior or concurrent malignancy (other than MDS, MPN, MDS\u002FMPN, or AML) 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. Treatment must be at least 12 months from last dose of chemotherapy or immunotherapy (except no window is required for palliative radiation or supportive or hormonal therapies). Concurrent malignancy must be considered not active or requiring therapy.\n* Male subjects and female subjects\u002Fwomen of childbearing potential (WCBP) must agree to the following: The effects of eganelisib on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men 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. When eganelisib is being used alone, the duration of contraception after the last dose should be 3 months for both males and females of childbearing potential. When eganelisib is being used with azacitidine + venetoclax, according to the USPI for azacitidine, females of reproductive potential should use effective contraception during treatment with azacitidine and for 6 months after the last dose and males with female partners of reproductive potential should use effective contraception during treatment with azacitidine and for 3 months after the last dose. WCBP must have negative serum beta human chorionic gonadotropin test measured within 7 days prior to the first dose of eganelisib and consent to ongoing pregnancy testing during the study.\n* Willingness to practice adequate sun protection (i.e. use of sunscreen or sun-protective clothing, limitation of sun and artificial ultraviolet \\[UV\\] exposure) for the study duration and for 30 days after the last dose of eganelisib.\n* Agree to the protocol-required bone marrow biopsies.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior systemic cancer therapy is allowed as long as \\>14 days prior to study treatment start. Hormonal therapy may be allowed if approved by Sponsor-Investigator.\n* Major surgery within 28 days prior to study treatment start.\n* Allogeneic stem cell transplant within 100 days prior to study treatment start.\n* Active graft-versus-host disease (GVHD) after allogeneic stem cell transplantation or chronic GVHD requiring systemic steroid administration. Topical therapies are allowed for controlled GVHD.\n* Receiving systemic immunosuppressive therapy such as steroids or calcineurin inhibitors.\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy with the exception of alopecia.\n* Participants who are receiving any other investigational AML directed-agents for this condition.\n* White blood cell count \\> 25x109\u002FL prior to first dose of study treatment.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to eganelisib, venetoclax, or azacitidine.\n* Participants receiving any medications or substances within 14 days prior to first dose of study drug and for duration of the study:\n\n  * Moderate or strong inhibitors or inducers of CYP2C8 and CYP3A4, including grapefruit, grapefruit juice, Seville oranges, St. John's wort and herbal supplements, except for antibiotics, antifungals, or antivirals that are moderate or strong inhibitors of CYP3A (preference for moderate CYP3A inhibitors if antifungal therapy is recommended when clinically acceptable).\n  * P-glycoprotein (P-gp) inhibitors except for azole antifungals.\n  * Breast cancer resistance protein (BCRP) inhibitors.\n* Administration of any of the following as of Cycle 1 Day 1 and for the study duration: Substrates with a narrow therapeutic index for P-gp, or Warfarin, phenytoin, or other substrates with a narrow therapeutic index for CYP2C8 or CYP2C9\n* Pregnant women are excluded from this study because eganelisib is an agent without known fertility and developmental toxicity studies. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with eganelisib, breastfeeding should be discontinued if the mother is treated with eganelisib. These potential risks may also apply to other agents used in this study.\n* History or current evidence of any acute or chronic condition, therapy, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or might confound the results of the trial, interfere with participation for the full duration of the trial, or render trial participation not compatible with the participant's best interest, in the opinion of the Investigator.\n* Participant must be able to swallow pills and not have any known gastrointestinal abnormality that would affect drug absorption (examples include gastric bypass, gastrectomy, chronic diarrhea).","18 Years","90 Years",{"count":61,"type":20},48,[23],"This study is to evaluate the safety and preliminary efficacy of adding the PI3K-gamma inhibitor, eganelisib, to a standard of care treatment option with combination venetoclax and azacitidine in participants with acute myeloid leukemia (AML).\n\nThe names of the study drugs involved in this research study are:\n\n* Venetoclax (a type of BCL-2 inhibitor)\n* Azacitidine (a type of Demethylating Agent)\n* Eganelisib (a type of PI3K-gamma inhibitor)",[65,27,32,30],"Leukemia, Myeloid",[65,27,32,67,68,69],"Refractory Acute Myeloid Leukemia","Relapsed Acute Myeloid Leukemia","AML","NOT_YET_RECRUITING","2026-02-28",{"date":73,"type":42},"2026-03-03",{"date":75,"type":20},"2026-07",{"date":77,"type":20},"2029-02-01",{"name":79,"class":48},"Jacqueline Garcia, MD",2,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":91,"conditions":92,"keywords":96,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100565592","phase-1-roginolisib-ioa-244-with-venetoclax-and-rituximab-for-refractoryrelapsed-chronic-lymphocytic-leukemia-cll-100565592","NCT06644183","Roginolisib (IOA-244) With Venetoclax and Rituximab for Refractory\u002FRelapsed Chronic Lymphocytic Leukemia (CLL)","A Phase 1\u002F2, Open Label, Study of Roginolisib (IOA-244), an Orally Bioavailable, Selective PI3Kδ Inhibitor in Patients With Refractory\u002FRelapsed Chronic Lymphocytic Leukemia (CLL) in Combination With Venetoclax and Rituximab","Inclusion Criteria:\n\n* Patients with relapsed\u002Frefractory CLL who meet iwCLL criteria for requiring treatment.\n* Patients with measurable disease as defined by at least one of: circulating lymphocytosis \\> 5000 B cells\u002Fmicroliter, bone marrow involvement \\> 30%, palpable splenomegaly or lymph nodes \\> 1.5 cm. Computer tomography (CT) at screening must be performed and followed every 2 cycles (1 cycle = 28 days).\n* Patients must have received at least two prior therapies for CLL including systemic therapy containing a covalent BTK inhibitor.\n* Patients willing to undergo a pre-treatment and on treatment bone marrow biopsy.\n* Age ≥18 years, at the time of signing the IRB approved informed consent. Because no dosing or adverse event data are currently available on the use of venetoclax in combination with roginolisib in participants \\\u003C18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.\n* Participants must meet the following organ and marrow function as defined below:\n\n  * Platelet count ≥50 x 109\u002FL\\^\\^\\^\n  * Total bilirubin ≤ 1.5 ×institutional upper limit of normal (ULN)\\*\n  * AST(SGOT)\u002FALT(SGPT) ≤3.0 × institutional ULN\n  * Creatinine clearance ≥ 60 mL\u002Fmin\\*\\*\n  * \\^\\^\\^Thrombocytopenia due to marrow involvement of CLL: \\> 30 x 109\u002FL for the safety run-in, and 20 x 109\u002FL for the randomized portion of the study\n  * \\*unless increase attributed to leukemic organ involvement, hemolysis or Gilbert's syndrome. Patients who are \\\u003C 75 years may have bilirubin of ≤ 3.0 × ULN\n  * \\*\\* calculated by the Cockcroft Gault formula or measured by 24 hours urine collection\n* Patients with clinically inactive CNS disease or treated CNS disease that is no longer symptomatic, or who need corticosteroids or anticonvulsants may be enrolled in the study. For patients who have symptoms present, imaging and lumbar puncture must be performed to exclude a CNS condition that may impact the study conduct.\n* Willingness to undergo a pre-treatment and on-treatment bone marrow to evaluate MRD.\n* Willingness to use adequate contraception prior to study entry and for the duration of study participation.\n\n  * The effects of roginolisib on the developing human fetus are unknown.\n  * Venetoclax may cause embryo fetal harm when administered to pregnant women. Anti-CD20 targeting agents are likely to cause fetal B-cell depletion. For this reason women of child-bearing potential and men 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. Women of child-bearing potential will be required to have a negative serum pregnancy test during screening and a negative serum pregnancy test on Cycle 1 Day 1. 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.\n  * Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of roginolisib or venetoclax administration. Contraception must be conducted up to 12 months after taking the last rituximab dose.\n* Ability to understand and the willingness to sign a written informed consent document, which includes compliance with the requirements of this protocol.\n* Eligible to receive infection prophylaxis and supportive care as per institutional guidelines.\n\nExclusion Criteria:\n\n* Patients who have received prior treatment with venetoclax or PI3K inhibitors in the last 6 months. Patients must not have had any CLL-directed anticancer therapy within 5 half- lives of the therapy prior to Cycle 1 Day 1.\n* Patients who have received a live vaccine within 30 days of planned start of study therapy. With regards to other type of vaccines, including SARS-Co2 vaccines, these are allowed.\n* Patients requiring ongoing treatment with chronic high dose immunosuppressants (e.g., cyclosporine) or systemic steroids \\> 20 mg prednisone (or equivalent) QD. For example, patients with uncontrolled autoimmune haemolytic anaemia (AIHA) or idiopathic thrombocytopenia purpura (ITP), which requires \\> 20 mg once daily (QD) of prednisone (or equivalent) to maintain haemoglobin levels of \\>8.0 g\u002FdL or platelets \\> 10,000 mL without transfusion support.\n* History of transformation of CLL to aggressive non-Hodgkin lymphoma (Richter´s transformation or pro-lymphocytic leukaemia) which may otherwise interfere with the interpretation of the outcome of the study (including biomarker evaluation).\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 fatigue. Any irAEs from prior immunotherapy must have complete resolution and must have resolved at least 2 weeks before Cycle1 Day1.\n* Participants who are receiving any other investigational agents for this condition.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to roginolisib or venetoclax or their formulation components or prior anti- CD20 targeting agents more than 6 months before initiating study treatments.\n* Patients with a history of systemic autoimmune disease.\n* Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A are ineligible. Moderate CYP3A inhibitors and P-gp inhibitors can be administered when venetoclax dose is reduced to 50%. Otherwise, venetoclax is contraindicated in patients requiring strong or moderate CYP3A inducers.\n\n  * Because of ongoing research, regularly consulting medical reference databases is recommended. One such reference is the Website of the US-FDA: (Drug Interactions \\| Relevant Regulatory Guidance and Policy Documents \\| FDA)\n  * As part of the enrollment\u002Finformed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.\n* Pregnant women are excluded from this study because venetoclax has the potential to cause embryo-fetal harm, and the potential for teratogenic or abortifacient effects with roginolisib is currently unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with roginolisib or venetoclax breastfeeding should be discontinued if the mother is treated with these agents.\n* Patients with a history of other primary malignancy are excluded when they require therapy that will interfere with the investigational treatments. Exceptions are if the natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen. For example:\n\n  * Malignancies surgically treated with curative intent and with no known active disease present for ≥2 years before the first dose of study treatment.\n  * Adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease.\n  * Adequately treated cervical carcinoma in situ without evidence of disease.\n  * Surgically\u002Fadequately treated low-grade, early-stage, localized prostate cancer without evidence of disease or low risk localized prostate cancer on observation.\n* Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.\n* History or presence of cardiovascular disease, which in the Investigator's opinion may impact the clinical trial participation. Patients with a QTcF \\> 470 msec at screening.\n* History of tuberculosis treatment within the preceding two years.\n* Ongoing systemic bacterial, fungal, or viral infections (including also hepatitis viral infection) at the time of initiation of study treatment (defined as requiring intravenous \\[IV\\] antimicrobial, antifungal or antiviral agents). Subjects on antimicrobial, antifungal or antiviral prophylaxis are not specifically excluded if all other inclusion\u002Fexclusion criteria are met, there is no evidence of active infection at enrollment, and ongoing treatment does not have a significant risk of drug-drug interaction with venetoclax.\n* Known Human immunodeficiency virus (HIV) infection which is treated with agents that can interfere with venetoclax due to potential drug-drug interactions or increased risk of myelotoxicity.\n* Any serious or uncontrolled medical disorder or active infection that, in the opinion of the Investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the patient to receive protocol therapy.\n* Known alcohol or substance abuse.",{"count":89,"type":20},64,[23,24],"This research study will test the safety and anticancer activity of the combination of three drugs (Roginolisib, Venetoclax, and Rituximab) for participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL).\n\nThe names of the study drugs involved in this study are:\n\n* Roginolisib (a novel type of PI3-kinase delta inhibitor)\n* Venetoclax (a type of B-cell lymphoma 2 inhibitor)\n* Rituximab (a type of monoclonal antibody)",[27,93,94,95,30],"Relapsed Leukemia","Chronic Lymphocytic Leukemia","Relapsed Cancer",[27,93,94,95,30,97,98,99],"CLL","Relapsed Chronic Lymphocytic Leukemia","Refractory Chronic Lymphocytic Leukemia","2026-02-09",{"date":102,"type":42},"2026-02-11",{"date":104,"type":42},"2025-03-19",{"date":106,"type":20},"2032-10-01",{"name":108,"class":48},"Jennifer R. Brown, MD, PhD",1,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":117,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":21,"phases":120,"briefSummary":121,"conditions":122,"keywords":123,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":109},"100615789","phase-1-phase-1-study-of-chemotherapy-plus-hla-mismatched-gpbmc-infusion-bridging-to-allo-hsct-for-rr-leukemia-100615789","NCT07297173","Phase 1 Study of Chemotherapy Plus HLA-mismatched GPBMC Infusion Bridging to Allo-HSCT for R\u002FR Leukemia","Phase 1 Study of Chemotherapy Combining With HLA-mismatched G-CSF Mobilized Peripheral Blood Mononuclear Cell Infusion as a Bridge to Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed and Refractory Leukemia","Inclusion Criteria:\n\n* Age \\>=15 years, male or female, non-limited by race or ethnicity.\n* Confirmed diagnosis of R\u002FR leukemia and risk stratification according to the World Health Organization (WHO) 5th edition classification, based on histopathology and cytogenetics.\n* Adequate hepatic function including alanine transaminase (ALT) and aspartate aminotransferase (AST )\\\u003C= 3 × upper limit of normal(ULN), and total bilirubin \\\u003C= 1.5 × ULN.\n* Adequate renal function including serum creatinine \\\u003C= 2 × ULN or CrCl\\>= 40mL\u002Fmin.\n* LVEF measured by echocardiogram is within the normal range (LVEF \\> 50%).\n* The subject must have one HLA mismatched donor who is \\>= 18 years old to provide GPBMCs for the first-step infusion. If this donor is not qualified as an allo-HSCT donor, the subject must also have another donor who is \\>= 18 years old and qualified as allo-HSCT donor (i.e., matched sibling, 9-10\u002F10 loci matched unrelated, or haploidentical). In addition, the donor voluntarily donates hematopoietic stem cells and signs the consent form. Each subject (or his\u002Fher legal representatives) must sign the Informed Consent Form (ICF), indicating that he\u002Fshe understands the purpose and procedures of research, and is willing to participate in research.\n* Donor inclusion criteria: The donor meets the institution's criteria for related peripheral blood hematopoietic stem cell donors. The donor must be able to tolerate the cell separation and collection process, and sign the Informed Consent Form.\n\nExclusion Criteria:\n\n* Uncontrolled infection or hemorrhage.\n* Cardiovascular disease with clinical significance, such as uncontrolled or highly symptomatic cardiac arrhythmias, congestive heart failure, or myocardial infarction within 6 months prior to screening, or New York Heart Association (NYHA) function class 3 (moderate) or class 4 (severe) heart disease.\n* Uncontrolled autoimmune disease or requiring immunosuppression treatment.\n* History of severe blood infusion reaction.\n* Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception.\n* Psychiatric disorder or cognitive impairment that in the researcher's judgment would make the subject not likely to adhere to the protocol requirements.\n* Major surgery within 4 weeks prior to enrollment.\n* Life-threatening illness other than leukemia or uncontrolled intercurrent illness.","15 Years",{"count":119,"type":20},5,[23],"This is a Phase 1 clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of chemotherapy combining with HLA-mismatched G-CSF mobilized peripheral blood mononuclear cell (GPBMC) infusion as a bridging therapy to allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with relapsed and refractory (R\u002FR) leukemia.",[93,30],[124,125,126,127],"HLA-mismatched GPBMC","allo-HSCT","relapsed leukemia","refractory leukemia","2025-12-09",{"date":130,"type":42},"2025-12-22",{"date":132,"type":42},"2025-12-01",{"date":134,"type":20},"2030-12-01",{"name":136,"class":48},"Beijing 302 Hospital",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":21,"phases":146,"briefSummary":147,"conditions":148,"keywords":151,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":109},"100462759","phase-2-venetoclax-combining-chidamide-and-azacitidine-vca-in-the-treatment-of-rr-aml-100462759","NCT05305859","Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of R\u002FR AML","A Multi-center, Prospective, Single-arm Study of Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of Refractory\u002FRelapsed Acute Myelogenous Leukemia (R\u002FR AML)","Inclusion Criteria:\n\n* Age ≥18\n* Relapsed and refractory patients with acute myeloid leukemia via morphology and immunology\n* ECOG：0-2\n* Life expectancy ≥ 3 months\n* Adequate laboratory parameters during the screening period as evidenced by the following:\n\n  1. Creatinine clearance≥30 mL\u002Fmin and serum Creatinine ≤ 160µmol\u002FL\n  2. ALT and AST ≤ 3 × upper limit of normal (ULN)\n  3. Able to understand and sign an informed consent form (ICF).\n\nExclusion Criteria:\n\n* Diagnosis of acute promyelocytic leukemia (APL)\n* Central nervous system leukemia\n* Uncontrolled or significant cardiovascular disease, including any of the following:\n\n  1. Bradycardia of less than 50 beats per minute, unless the subject has a pacemaker; Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);\n  2. Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg; History of clinically relevant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes);\n  3. History of second (Mobitz II) or third degree heart block (subjects with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker);\n  4. History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening;\n  5. History of New York Heart Association Class 3 or 4 heart failure;\n  6. Complete left bundle branch block;\n  7. Known history of left ventricular ejection fraction (LVEF) ≤45% or less than the institutional lower limit of normal;\n* Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy;\n* Suffered from other non-myeloid malignancies within 2 years, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease\n* Females who are pregnant or breastfeeding;\n* Mental disorders that hinder research participation\n* Previous solid organ transplantation (SCT treatment is allowed in advance, but if the patient has GVHD or is still receiving immunosuppression\u002FGVHD treatment, it is not allowed)\n* Any other situation where the investigator believes that the patient should not participate in this trial",{"count":145,"type":20},30,[24],"The purpose of this study is to evaluate the safety and efficacy of Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of relapsed and\u002For refractory AML",[149,150,30],"Leukemia, Myeloid, Acute","Relapsed Adult AML",[152],"refractory\u002Frelapsed acute myelogenous leukemia","2025-09-04",{"date":155,"type":42},"2025-09-11",{"date":157,"type":42},"2022-01-12",{"date":159,"type":20},"2027-06-30",{"name":161,"class":48},"The First Affiliated Hospital of Xiamen University",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":169,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":21,"phases":173,"briefSummary":174,"conditions":175,"keywords":176,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":187},"100506177","phase-2-chemotherapy-clage-ven-sequential-with-reduced-intensity-conditioning-for-refractory-acute-myelodi-leukemia-100506177","NCT05870995","Chemotherapy CLAGE-Ven Sequential With Reduced Intensity Conditioning for Refractory Acute Myelodi Leukemia","A Phase II Single Arm Study of Cladribine, Cytarabine, Etoposide and Venetoclax Sequential With Reduced Dose Conditioning of Fludarabine, Busulfan and Melphalan or Total Marrow Radiation for Refractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* patients with refractory AML: no remission after 2 induction therapy, relapsed AML within 6 months of 1st CR, relapse AML fail to having CR after reinduction therapy, multiple relapse and refractory relapse AML\n* patients with \\>5% bone marrow blast by morphology or by LAIP flowcytometry at enrollment\n* patients with HLA-matched sibling donor, 9-10\u002F10 matched unrelated donor or haplo-identical family donor\n* patients without active infection\n* informed consent provided\n\nExclusion Criteria:\n\n* patients with abnormal liver function (enzyme \\>2N or bilirubin \\>2N)\n* patients with abnormal renal function (Scr \\>1.5N)\n* patients with poor cardiac function （EF\\\u003C45%）","16 Years","65 Years",{"count":172,"type":20},100,[24],"The investigators developed a protocol combining chemotherapy of cladribine, cytarabine and etoposide (CLAGE) as debulking treatment sequential with reduced intensity conditioning regimen Flu-Bu to treat patients with refractory acute myeloid leukemia (AML). In this study, the aim is to further evaluate the efficacy and feasibility of the protocol with modifications: 1) reduced dose of CLAGE; 2) Reduced intensity conditioning (RIC) regimen as fludarabine, busulfan and melphalan (MBF) or total marrow irradiation (TMI); 3) Venetoclax was added to the chemotherapy and conditioning regimen.",[30],[177],"refractory AML, allogeneic stem cell transplantation","2025-02-14",{"date":180,"type":42},"2025-02-18",{"date":182,"type":42},"2023-02-01",{"date":184,"type":20},"2026-09-01",{"name":186,"class":48},"Shanghai Jiao Tong University School of Medicine",3,{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":196,"enrollmentInfo":197,"targetDuration":4,"studyType":198,"phases":4,"briefSummary":199,"conditions":200,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":109},"100442827","solving-riddles-through-sequencing-100442827","NCT05046444","Solving Riddles Through Sequencing","Testing the Diagnostic Supremacy of Sequencing-only Approaches in Hematologic Malignancies: an Observational Trial","SIRIUS","Inclusion Criteria:\n\n* Patients having been investigated with a suspected hematological disorder and:\n* Having unclear diagnosis after internal routine diagnosis\n* Unusual clinical course\n* Unusual r\u002Fr status or non-responder\n* Multiple parallel hematological conditions\n* Difficult\u002Frare therapy associated\u002Fsecondary neoplasms\n* Current diagnostic workup is not satisfactory in terms of (1) accuracy (2) clinical behavior\n* Only samples of patients min. 18 years of age will be used\n* Material with a minimum of 20% tumor content in bone marrow or peripheral blood sample\n* Patient´s informed consent\n\nExclusion Criteria:\n\n* Sample is not fit for state-of-the-art diagnosis, fails initial quality control. For quality insurance we will exclude samples with wrong anticoagulant sent. Samples with damage due to meteorological reasons (freeze-thaw damage or elevated temperature) will be excluded.\n* Samples with to scarce material jeopardizing routine gold-standard diagnosis will be excluded (tumor content \\\u003C 20 %).","99 Years",{"count":172,"type":20},"OBSERVATIONAL","During the last decades hematologists have excelled at improving and refining the classification, diagnosis, and thus ultimately the therapeutic decision-making process for their patients. This continuous evolution proceeded in parallel to seminal discoveries in basic science such as FISH, PCR and NGS. So far, the current WHO classification serves as reference to diagnostic decision making and is largely based on 5 diagnostic pillars: cytomorphology of peripheral blood and\u002For bone marrow smears, histology and immunohistochemistry of bone marrow trephine biopsies or lymph nodes, immunophenotyping, chromosome banding analysis supplemented by FISH analysis, molecular genetics including PCR and targeted panel sequencing via NGS. This leads to a swift diagnosis in 90 % of all cases. The leftover 10 % remain a challenge for hematopathologists and clinicians alike and are resolved through interdisciplinary teams in the context of specialized boards. With the advent of high throughput sequencing (mainly WGS and WTS) the possibility of a comprehensive and detailed portrait of the genetic alterations - specifically in challenging cases - has become a realistic alternative to classical methods. In SIRIUS the investigators will prospectively challenge this hypothesis to address the question of how often a better or final diagnosis can be delivered by WGS and\u002For WTS and if unclear cases can be efficiently resolved.",[27,201,202,30,203,204],"Hematologic Malignancy","Rare Diseases","Refractory Lymphoma","Unknown Primary Tumors","2024-12-14",{"date":207,"type":42},"2024-12-17",{"date":209,"type":42},"2022-01-19",{"date":211,"type":20},"2026-10-01",{"name":213,"class":214},"Munich Leukemia Laboratory","INDUSTRY",{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":222,"enrollmentInfo":223,"targetDuration":4,"studyType":21,"phases":225,"briefSummary":226,"conditions":227,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":109},"100516583","phase-1-safety-and-efficacy-of-cd123-targeted-car-nk-for-relapsedrefractory-acute-myeloid-leukemia-or-blastic-plasmacytoid-dendritic-cell-neoplasm-100516583","NCT06006403","Safety and Efficacy of CD123-targeted CAR-NK for Relapsed\u002FRefractory Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm","Clinical Study of Targeting CD123 Chimeric Antigen Receptor Natural Killer Cells (CAR-NK) in the Treatment of Relapsed\u002FRefractory Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm","Inclusion Criteria:\n\n1. Gender is not limited, age 18-75 years old (including the threshold value);\n2. The expression of CD123 in tumor cells was detected by flow cytometry.\n3. Patients with relapsed\u002Frefractory AML or BPDCN diagnosed with CD123 positive: 1) AML: a. Recurrent: After complete response (CR), the recurrence of leukemia cells in peripheral blood or bone marrow original cells ≥5% (except for other reasons such as bone marrow regeneration after consolidation chemotherapy) or the occurrence of extramedullary leukemia cell infiltration; b. Refractory: refers to those who have failed to receive 2 courses of treatment with standard protocols; Patients recurrence within 12 months after CR with consolidation and intensive treatment; Recurrence after 12 months but failed to respond to conventional chemotherapy; 2 or more relapses; Extramedullary leukemia persists;\n\n2\\) BPDCN: has failed to receive guidelines-recommended salvage therapy or is unable to tolerate current therapy, and has persistent or recurrent disease in any of the peripheral blood, bone marrow, lymph nodes, spleen, skin lesions, or other site lesions.\n\n4\\. Expected survival time is more than 12 weeks;\n\n5\\. ECOG 0-2 points (Appendix 2);\n\n6\\. No serious mental disorders; The functions of important organs are basically normal:\n\n1. Cardiac function: echocardiography indicated cardiac ejection fraction ≥50%, and no obvious abnormality was found in electrocardiogram;\n2. Renal function: serum creatinine ≤2.0×ULN;\n3. Liver function: ALT and AST ≤ 3.0×ULN;\n4. Total bilirubin and alkaline phosphatase ≤ 2.0×ULN (Gilbert syndrome ≤ 3.0×ULN);\n5. Blood oxygen saturation \\> 92%.\n\n   7\\. The patient or his\u002Fher guardian agrees to participate in the clinical trial and signs the ICF, indicating that he\u002Fshe understands the purpose and procedure of the clinical trial and is willing to participate in the study.\n\nExclusion Criteria:\n\n1. Prior to screening, the following anti-tumor therapies were received: chemotherapy, targeted therapy, or other investigational drug treatment within 14 days or at least 5 half-lives (whichever is shorter), except in cases where disease progression has been confirmed after treatment;\n2. had a cerebrovascular accident or seizure within 6 months before signing the ICF;\n3. There is an active or uncontrolled infection that requires systemic treatment within 1 week prior to screening;\n4. suffering from any of the following heart diseases:\n\n   1. New York Heart Association (NYHA) Stage III or IV congestive heart failure;\n   2. Had myocardial infarction or coronary artery bypass grafting (CABG) within ≤6 months before enrollment;\n   3. A history of clinically significant ventricular arrhythmia, or unexplained syncope (other than those caused by vasovagal or dehydration);\n   4. History of severe non-ischemic cardiomyopathy;\n5. combined with active hepatitis B;\n6. Combined with active autoimmune diseases, long-term immunosuppressive therapy is required;\n7. have other malignancies, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery;\n8. Had received live attenuated vaccine within 4 weeks prior to screening;\n9. Women who are pregnant or breastfeeding, and male or female subjects who plan to have a family within 1 year after receiving CAR T cell transfusion;\n10. Circumstances deemed unsuitable for participation in the study by other researchers.","75 Years",{"count":224,"type":20},36,[23,24],"This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of targeting CD123 CAR-NK cell preparations in Relapsed\u002Frefractory acute myeloid leukemia (AML) or blastocytic plasmacytoid dendritic cell neoplasm (BPDCN). The pharmacokinetic characteristics of CAR-NK cell preparations for the treatment of patients with Relapsed\u002Frefractory acute myeloid leukemia or blastocytic plasmacytoid dendritic cell neoplasm were obtained and the recommended dose.",[32,228,29,30],"Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)","2023-08-28",{"date":231,"type":42},"2023-08-30",{"date":233,"type":20},"2023-08-31",{"date":235,"type":20},"2026-08-31",{"name":237,"class":214},"Chongqing Precision Biotech Co., Ltd",{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":16,"minAge":245,"maxAge":170,"enrollmentInfo":246,"targetDuration":4,"studyType":21,"phases":248,"briefSummary":249,"conditions":250,"keywords":257,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":109},"100442606","phase-1-cartall-chimeric-antigen-receptor-car-t-cell-therapy-for-relapsed-refractory-t-lineage-acute-lymphoblastic-leukaemia-100442606","NCT05043571","CARTALL: Chimeric-Antigen Receptor (CAR) T-Cell Therapy for Relapsed\u002F Refractory T-Lineage Acute Lymphoblastic Leukaemia","Anti-CD7 Protein Expression Blocker (PEBL) Chimeric-Antigen Receptor (CAR) T-Cell Therapy for Relapsed\u002F Refractory T-Lineage Acute Lymphoblastic Leukaemia (CARTALL)","Inclusion Criteria:\n\n* Diagnosis\u002F Disease define as:\n\n  1. Relapsed T-cell acute lymphoblastic leukaemia\u002F lymphoma as defined by:\n\n     Bone marrow disease = or \\> 0.01% by MRD as determined by flow cytometry\n\n     Or CNS disease as defined as \\> 5 WBCs\u002F uL in CSF with morphological evidence of blasts or biopsy proven recurrence in the eye or brain\n\n     Or Extramedullary relapse as defined by morphological evidence of blasts in the testis or any other extramedullary sites\n  2. Induction failure as defined by:\n\n     MRD = or \\> 1% by flow cytometry at the end of induction on day 33\n\n     Or Failure to achieve morphological remission defined as \\> 5% blasts after standard induction chemotherapy\n  3. Refractory disease as defined by:\n\n     MRD = or \\> 0.01% by flow cytometry or molecular methods during 2 or more timepoints after induction therapy\n* Minimum level of pulmonary reserve defined as Grade ≤ 1 dyspnoea and oxygen saturation (SpO2) of \\> 95% on room air\n* Left ventricular systolic function (LVSF) ≥ 28% confirmed by echocardiogram, or left ventricular ejection fraction (LVEF) ≥ 45% confirmed by echocardiogram within 3 months of screening\n* Karnofsky (age ≥ 16 years) or Lansky (age \\\u003C 16 years) performance status ≥ 50 at screening\n* Normal Age-adjusted eGFR Creatinine Clearance within 3 months of screening\n* Alanine aminotransferase ≤ 5 times the upper limit of normal for age\n* Patients with \\> 99% CD7 expression on blast cells will be eligible for anti-CD7 PEBL-CAR-T cell infusion.\n\nExclusion Criteria:\n\n* Failure to meet any of the inclusion criteria\n* Patients who test positive on urine pregnancy testing and are pregnant or are lactating\n* Concomitant genetic syndromes associated with bone marrow failure states, such as Fanconi anaemia, Kostmann syndrome, Schwachman syndrome, or any other bone marrow failure syndrome with the exception of Down syndrome\n* Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and no evidence of active disease\n* Active or latent hepatitis B or hepatitis C infections within 8 weeks of screening, or any uncontrolled infection at screening\n* Positive Human Immunodeficiency Virus (HIV) test within 8 weeks of screening\n* Grade 2 to 4 acute graft-vs-host disease (GVHD) or extensive chronic GVHD\n* Received an investigational medicinal product within 30 days of screening\n* Central nervous system : Uncontrolled seizures or status epilepticus; increased intra-cranial pressure as evidenced by papilledema and CSF opening pressure \\> 20 cm water; decreased conscious state (any cause)","6 Months",{"count":247,"type":20},20,[23],"The objective of this study is to assess the safety and efficacy of anti-CD7 CAR T-cells in patients with refractory or relapsed T-lineage acute lymphoblastic leukemia (T-ALL).",[251,252,253,254,255,256,30],"Lymphoblastic Leukemia, Acute, Childhood","Lymphoblastic Leukemia","Lymphoblastic Leukemia, Acute Adult","Lymphoblastic Leukemia in Children","CAR","CAR T-Cell-Related Encephalopathy Syndrome",[258,259,260],"T-ALL","CAR-T cell therapy","CAR T-cell therapy","2021-09-07",{"date":263,"type":42},"2021-09-14",{"date":265,"type":20},"2021-09-08",{"date":267,"type":20},"2026-11-01",{"name":269,"class":48},"National University Hospital, Singapore"]