[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-myelogenous-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-myelogenous-leukemia":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,74,111,151,187,224,246,270,294,329,358,380,400],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":54,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100309946","phase-2-myeloablative-allo-hsct-with-related-or-unrelated-donor-for-heme-disorders-100309946",false,"NCT03314974","Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders","Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Unrelated Donor for the Treatment of Hematological Diseases","-Inclusion Criteria:\n\n* Age: ≤ 60 years of age\n* Performance Status: Karnofsky ≥ 70%, Lansky play score ≥ 70\n* Consent: Voluntary written consent (adult or legally authorized representative; or parental\u002Fguardian)\n* Adequate Organ Function:\n\n  * Renal: Creatinine \\\u003C2x upper limit of normal. Patients above this limit must have creatinine clearance ≥ 40 ml\u002Fmin\u002F1.73m2 as determined by an age-appropriate method, such as cystatin C GFR.\n  * Hepatic: Bilirubin, AST, alkaline phosphatase \\\u003C4 times the upper limit of institutional normal\n  * Pulmonary: Diffusion capacity of oxygen, corrected for hemoglobin, \\> 50% of predicted. For pediatric patients not able to undergo PFTs or diffusion testing: O2 sat of \\>95% on room air\n  * Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \\> 45%. For children not able to cooperate with MUGA or echocardiography, such should be clearly stated in the physician's documentation\n  * HIV Status: HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation\n\nOther Inclusion Criteria:\n\n* Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.\n* Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of the University of Minnesota Blood and Marrow Transplantation Program\n* Eligible Diseases and Status: Patients are eligible unless their treatment is to be guided by a higher priority protocol.\n* Acute Leukemias: Must be in remission by morphology (≤5% blasts). Also a small percentage of blasts that is equivocal between marrow regeneration vs. early relapse are acceptable provided there are no associated cytogenetic markers consistent with relapse.\n* Acute Myeloid Leukemia (AML) and related precursor neoplasms: 2nd or greater complete remission (CR); first complete remission (CR1) in patients \\> 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk.\n* Favorable risk AML is defined as having one of the following:\n\n  * t(8,21) without cKIT mutation\n  * inv(16) or t(16;16) without cKIT mutation\n  * Normal karyotype with mutated NPM1 and wild type FLT-ITD\n  * Normal karyotype with double mutated CEBPA\n  * Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation\n* Very high risk pediatric patients with AML: Patients \\\u003C21 years, however, are eligible with (M2 marrow) with \\\u003C 25% blasts in marrow after having failed one or more cycles of chemotherapy.\n* Acute lymphoblastic leukemia (ALL)\u002Flymphoma: second or greater CR; CR1 unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1 high-risk ALL.\n* High risk ALL is defined as having one of the following:\n\n  * Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1\n  * 30 years of age or older at diagnosis\n  * White blood cell counts of greater than 30,000\u002FmcL (B-ALL) or greater than 100,000\u002FmcL (T-ALL) at diagnosis\n  * CNS leukemia involvement during the course of disease\n  * Slow cytologic response (\\>10% lymphoblasts in bone marrow on Day 14 of induction therapy)\n  * Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy\n* Very high risk pediatric patients with ALL: patients \\\u003C21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieve a complete remission.\n* Chronic Myelogenous Leukemia excluding refractory blast crisis: To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to one or more tyrosine kinase inhibitors.\n* Plasma Cell Leukemia after initial therapy, in patients who have achieved at least a partial remission\n* Myeloproliferative Neoplasms\u002FMyelofibrosis, either primary as a result of polycythemia vera or essential thrombocythemia, with disease risk of intermediate or high-risk according to DIPSS criteria. Blasts must be \\\u003C10% by bone marrow aspirate morphology.\n* Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features. Blasts must be \\\u003C 10% by a representative bone marrow aspirate morphology.\n* Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma are eligible if there was disease progression\u002Frelapse within 12 of achieving a partial or complete remission. Patients who had remissions lasting \\> 12 months, are eligible after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm) should be considered for debulking chemotherapy before transplant.\n* Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia are eligible after initial therapy in CR1+ or PR1+.\n* Diffuse large Cell NHL \\> CR\u002F\\> PR: Patients in CR\u002FPR with initial short remission (\\\u003C6 months) are eligible, or those who have failed\u002For are not eligible for autologous transplant.\n* Lymphoblastic Lymphoma, Burkitt's Lymphoma, and other high-grade NHL after initial therapy if stage III\u002FIV in CR1\u002FPR1 or after progression if stage I\u002FII \\\u003C 1 year.\n* Multiple Myeloma beyond PR2: Patients with chromosome 13 abnormalities, first response lasting less than 6 months, or β-2 microglobulin \\> 3 mg\u002FL, may be considered for this protocol after initial therapy.\n* Juvenile myelomonocytic leukemia\n* Biphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias in first or subsequent CR.\n* MRD positive leukemia (AML, ALL or accelerated\u002Fblast phase CML). Selected patients in morphologic CR, but with positive immunophenotypic (flow cytometry) or molecular evidence of MRD may be eligible if recent chemotherapy has not resulted in MRD negative status.\n* Natural Killer Cell Malignancies\n* Acquired Bone Marrow Failure Syndromes except for Fanconi Anemia or Dyskeratosis Congenita\n* Other Leukemia Subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.\n\nExclusion Criteria:\n\n* Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after \\> 2 salvage regimens)\n* CML in blast crisis\n* Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy.\n* Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.\n* Active central nervous system malignancy\n* if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If \\>18 years old prior myeloablative allotransplant or autologous transplant\n* Active HIV infection or known HIV positive serology\n* active uncontrolled infection\n* Pregnant or breastfeeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.","ALL","60 Years",{"count":19,"type":20},300,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a Phase II study of allogeneic hematopoietic stem cell transplant (HCT) using a myeloablative preparative regimen (of either total body irradiation (TBI); or, fludarabine\u002Fbusulfan for patients unable to receive further radiation). followed by a post-transplant graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF).",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53],"Acute Leukemia","Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","Lymphoma","Chronic Myelogenous Leukemia","Plasma Cell Leukemia","Myeloproliferative Neoplasms","Myelofibrosis","Myelodysplasia","Refractory Anemia","High Risk Anemia","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Marginal Zone B-Cell Lymphoma","Follicular Lymphoma","Lymphoplasmacytic Lymphoma","Mantle-Cell Lymphoma","Prolymphocytic Leukemia","Diffuse Large Cell Non Hodgkins Lymphoma","Lymphoblastic Lymphoma","Burkitt Lymphoma","High Grade Non-Hodgkin's Lymphoma, Adult","Multiple Myeloma","Juvenile Myelomonocytic Leukemia","Biphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias","MRD Positive Leukemia","Natural Killer Cell Malignancies","Acquired Bone Marrow Failure Syndromes",[55,16,56,57,58,59,60],"AML","MDS","NHL","CLL","CML","SLL","RECRUITING","2026-06-23",{"date":64,"type":65},"2026-06-25","ACTUAL",{"date":67,"type":65},"2018-03-30",{"date":69,"type":20},"2028-06-10",{"name":71,"class":72},"Masonic Cancer Center, University of Minnesota","OTHER",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":110},"100429857","phase-4-asciminib-roll-over-study-100429857","NCT04877522","Asciminib Roll-over Study","An Open Label, Multi-center Asciminib Roll-over Study to Assess Long-term Safety in Patients Who Have Completed a Novartis Sponsored Asciminib Study and Are Judged by the Investigator to Benefit From Continued Treatment","Key Inclusion Criteria:\n\n1. Participant with PH+ CML or PH+ ALL currently receiving treatment with asciminib (single agent or in combination with imatinib, nilotinib or dasatinib), imatinib, nilotinib or bosutinib alone within a Novartis-sponsored study and, in the opinion of the Investigator, would benefit from continued treatment.\n2. Participant has demonstrated compliance on the parent study protocol and is willing and able to comply with scheduled visits, treatment plans and any other study procedures.\n\nKey Exclusion Criteria:\n\n1. Participant has been discontinued from parent study treatment.\n2. Participant currently has unresolved toxicities reported as possibly related to study treatment in the parent study.\n3. Participant's ongoing treatment is currently approved and reimbursed at country level.\n4. Pregnant or nursing (lactating) women.\n5. Women of child-bearing potential, unless they are using highly effective methods of contraception and willing to continue while taking study treatment.\n6. Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information.\n7. Applicable for participants on bosutinib treatment at the end of the CABL001A2301 and on other TKIs for CABL001A2202 study that switch to asciminib treatment:\n\n   * Asymptomatic (grade 2) pancreatitis if not resolved within 28 days\n   * QTcF\\>480msec or inability to determine QTc interval\n   * any grade 3 or 4 toxicity not resolved to grade 2 or lower within 28 days before starting asciminib treatment\n\nOther protocol-defined Inclusion\u002FExclusion criteria may apply.","7 Years","100 Years",{"count":84,"type":20},347,[86],"PHASE4","This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment",[30,89],"Leukemia, Myelogenous, Chronic, BCR-ABL Positive",[30,59,16,91,92,93,94,95,96,97,98,99],"CML-AP","CML-BP","CML-CP","myeloproliferative neoplasm","chronic phase","accelerated phase","blast phase","ABL001","asciminib","2026-06-08",{"date":102,"type":65},"2026-06-10",{"date":104,"type":65},"2022-08-30",{"date":106,"type":20},"2030-08-30",{"name":108,"class":109},"Novartis Pharmaceuticals","INDUSTRY",85,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":123,"conditions":124,"keywords":137,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":150},"100526212","pharmacokinetic-study-of-venetoclax-tablets-crushed-and-dissolved-into-a-solution-100526212","NCT06131801","Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution","A Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution in Children and Young Adults With Hematologic Malignancies","Inclusion Criteria:\n\n* Age: Patients must be \\\u003C39 years of age at time of study enrollment\n* Diagnosis: Patients may have a diagnosis of any hematologic malignancy\n* Central access: Patients must have an existing venous or arterial access line for PK blood draws\n* Weight requirement: Patients must weigh at least 5.5 kg at the time of enrollment\n* Venetoclax: Patients must be receiving any dose of venetoclax given as a solution made from crushed tablets by mouth (PO) or via nasogastric (NG), or G-tube as prescribed by their treating oncologist.\n* Concurrent chemotherapy medications: Patients may receive venetoclax as a single agent or in combination with any other chemotherapeutic agents.\n\nExclusion Criteria:\n\n* Pregnant women are excluded from this study because venetoclax has 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 venetoclax, breastfeeding should be discontinued if the mother is treated with venetoclax.\n* Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on study treatment and for six months following completion.","0 Years","38 Years",{"count":121,"type":20},30,"OBSERVATIONAL","The use of venetoclax-based therapies for pediatric patients with relapsed or refractory malignancies is increasingly common outside of the clinical trial setting. For patients who cannot swallow tablets, it is common to crush the tablets and dissolve them in liquid to create a solution. However, no PK data exists in adults or children using crushed tablets dissolved in liquid in this manner, and as a result, the venetoclax exposure with this solution is unknown.\n\nPrimary Objectives\n\n• To determine the pharmacokinetics of venetoclax when commercially available tablets are crushed and dissolved into a solution\n\nSecondary Objectives\n\n* To evaluate the safety of crushed venetoclax tablets administered as an oral solution\n* To determine the pharmacokinetics of venetoclax solution in patients receiving concomitant strong and moderate CYP3A inhibitors\n* To determine potential pharmacokinetic differences based on route of venetoclax solution administration (ie. PO vs NG tube vs G-tube)\n* To determine the concentration of venetoclax in cerebral spinal fluid when administered as an oral solution",[125,126,29,127,16,128,55,30,59,129,130,131,132,40,46,133,134,135,136],"Hematologic Malignancy","Leukemia","Acute Lymphocytic Leukemia","Acute Myelogenous Leukemia","Myeloproliferative Neoplasm","Non Hodgkin Lymphoma","Hodgkin Lymphoma","Diffuse Large B Cell Lymphoma","T-cell Lymphoma","B Cell Lymphoma","Peripheral T Cell Lymphoma","Cutaneous B-Cell Lymphoma",[138,139,140],"Venetoclax","Pediatric AML","Pediatric Relapsed\u002FRefractory AML","2026-06-02",{"date":143,"type":65},"2026-06-04",{"date":145,"type":65},"2023-11-15",{"date":147,"type":20},"2027-12-01",{"name":149,"class":72},"Children's Hospital Medical Center, Cincinnati",5,{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":16,"minAge":158,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":21,"phases":162,"briefSummary":163,"conditions":164,"keywords":166,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":186},"100620165","phase-2-study-to-determine-the-efficacy-and-safety-of-asciminib-in-pediatric-patients-with-ph-cml-cp-100620165","NCT07354074","Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP","A Phase II, Multicenter, Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Asciminib in Pediatric Participants Newly Diagnosed or Previously Treated With Philadelphia Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) With or Without Known T315I Mutation","Key Inclusion Criteria:\n\nParticipants eligible for inclusion in this study must meet all of the following criteria:\n\n1. Signed informed consent must be obtained prior to participation in the study.\n2. Male or female participants 1 and \\\u003C 18 years of age at study enrollment\n3. Diagnosis of CML-CP (Apperley et al 2025) with cytogenetic confirmation of Philadelphia positive (Ph+) chromosome\n4. For participants with CML-CP newly diagnosed within 3 months of screening OR 5 For participants with CML - CP with high risk of developing resistance or intolerance to previous TKI:\n\n   1. Unfavourable response to TKI is defined following the Apperley et al 2025 guidelines as:\n\n      * At three months after the initiation of therapy: BCR::ABL1 ratio \\> 10% IS (if confirmed within 1-3 months)\n      * At six months after the initiation of therapy: BCR::ABL1 ratio \\> 10% IS\n      * At twelve months after initiation of therapy: BCR::ABL1 ratio \\> 1% IS\n      * At any time loss of previous response\n      * At any time emergent resistant BCR::ABL1 mutations or high-risk ACA from prior TKI treatment as per local test results\n   2. Intolerance to TKI is defined as:\n\n      * Non-hematologic intolerance: participants with grade 3 or 4 toxicity while on therapy (in which case the patient is eligible whether or not there was a dose reduction); or with persistent grade 2 toxicity unresponsive to optimal management including dose adjustments (unless dose reduction is not considered in the best interest of the patient if response is already suboptimal)\n      * Hematologic intolerance: participants with grade 3 or 4 toxicity (absolute neutrophil count \\[ANC\\] or platelets) while on therapy that is recurrent after dose reduction to the lowest doses of the TKI\n\n6\\. Evidence of typical BCR::ABL1 transcript \\[e14a2 and\u002For e13a2\\] at the time of screening which are amenable to standardized RQ-PCR quantification.\n\n7\\. Performance status: Karnofsky ≥ 50% for participants ≥ 16 years of age, and Lansky ≥ 50 for participants \\\u003C 16 years of age at the time of screening.\n\nKey Exclusion Criteria:\n\n1. Known second chronic phase (CP) of CML after previous progression to Accelerated Phase (AP)\u002FBlast Phase (BP).\n2. Previous treatment with a hematopoietic stem-cell transplantation.\n3. Patient planned to undergo allogeneic hematopoietic stem cell transplantation\n4. Known presence of a BCR::ABL1 mutation with known resistance to study treatment in accordance with the most recent public version of international CML clinical guidelines (e.g. NCCN CML treatment guidelines v 1.2026 and Apperley et al 2025) any time prior to study entry\n\nOther inclusion\u002Fexclusion criteria may apply.","1 Year","18 Years",{"count":161,"type":20},50,[23],"The aim of this study is to support development of asciminib in the pediatric population (1 to \\\u003C 18 years) with Ph+ CML-CP. The study will evaluate the efficacy and safety of asciminib in pediatric formulation (weigh-based dose, fed state) or adult formulation (fasted) in newly diagnosed and resistant or intolerant Ph+ CML-CP with or without T315I mutation.",[30,165],"Leukemia, Myelogenous, Chronic, Philadelphia Chromosome Positive",[167,98,168,169,170,171,172,173,174,59,175,176,177],"Asciminib","Pediatric participants","Philadelphia chromosome positive chronic myeloid leukemia in chronic phase","Ph+ CML-CP","tyrosine kinase inhibitor","TKI","Molecular Response","MR","Chronic phase","T3151","Ph+","2026-05-21",{"date":180,"type":65},"2026-05-26",{"date":182,"type":65},"2026-04-28",{"date":184,"type":20},"2033-02-23",{"name":108,"class":109},4,{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":16,"minAge":195,"maxAge":196,"enrollmentInfo":197,"targetDuration":4,"studyType":21,"phases":199,"briefSummary":200,"conditions":201,"keywords":204,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":223},"100430719","phase-2-methods-of-t-cell-depletion-trial-motd-100430719","NCT04888741","Methods of T Cell Depletion Trial (MoTD)","A Multi-centre Phase II Trial of GVHD Prophylaxis Following Unrelated Donor Stem Cell Transplantation Comparing Thymoglobulin vs. Calcineurin Inhibitor or Sirolimus-based Post-transplant Cyclophosphamide","MoTD","Inclusion Criteria:\n\n* Availability of suitably matched unrelated donor (9\u002F10 or 10\u002F10)\n* Planned to receive one of the following RIC protocols:\n\n  * Fludarabine-Melphalan (Fludarabine 120-180mg\u002Fm2 IV; melphalan ≤ 150mg\u002Fm2 IV)\n  * BEAM or LEAM (carmustine 300mg\u002Fm2 IV or lomustine 200mg\u002Fm2 IV with: etoposide 800 mg\u002Fm2 IV; cytarabine 1600mg\u002Fm2 IV; melphalan 140mg\u002Fm2 IV)\n  * Fludarabine-Busulphan (Fludarabine 120-180mg\u002Fm2 IV; Busulphan ≤ 8mg\u002Fkg PO or 6.4mg\u002Fkg IV)\n  * Fludarabine- Treosulfan (Fludarabine 150mg\u002Fm2 IV; Treosulfan 30g\u002Fm2 IV)\n* Planned use of PBSCs for transplantation\n* Planned allo-SCT for one of the following haematological malignancies:\n\n  * AML in CR (patients enrolled onto the COSI trial are not eligible for this study)\n  * ALL in CR (patients enrolled onto the ALL-RIC trial are not eligible for this study)\n  * CMML \\\u003C10% blasts\n  * MDS \\\u003C10% blasts (patients enrolled onto the COSI trial are not eligible for this study)\n  * NHL in CR\u002FPR\n  * HL in CR\u002FPR\n  * MM in CR\u002FPR\n  * CLL in CR\u002FPR\n  * CML in 1st or 2nd chronic phase\n  * Myelofibrosis\n* Age 16-70 years\n* Females of and male patients of reproductive potential (i.e., not post-menopausal or surgically sterilised) must agree to use appropriate, highly effective, contraception from the point of commencing therapy until 12 months after transplant\n\nExclusion Criteria:\n\n* Use of any method of graft manipulation (excluding storage of future DLI)\n* Use of alemtuzumab or any method of T cell depletion except those that are protocol-defined\n* Known hypersensitivity to study drugs or history of hypersensitivity to rabbits\n* Pregnant or lactating women\n* Adults of reproductive potential not willing to use appropriate, highly effective, contraception during the specified period\n* Life expectancy \\\u003C8 weeks\n* Active HBV or HCV infection\n* Organ dysfunction defined as:\n\n  * LVEF \\\u003C45%\n  * GFR \\\u003C50ml\u002Fmin\n  * Bilirubin \\>50µmol\u002Fl\n  * AST\u002FALT\\>3 x ULN\n* Participation in COSI or ALL-RIC trials\n* Contraindication to treatment with the study drugs (Thymoglobulin, cyclophosphamide, sirolimus, ciclosporin and mycophenolate mofetil) as detailed in each study drug SPC.\n* Patient has any other systemic dysfunction (e.g., gastrointestinal, renal, respiratory, cardiovascular) or significant disorder which, in the opinion of the investigator would jeopardise the safety of the patient by taking part in the trial.","16 Years","70 Years",{"count":198,"type":20},400,[23],"A multi-centre phase II trial of GvHD prophylaxis following unrelated donor stem cell transplantation comparing Thymoglobulin vs. Calcineurin inhibitor or Sirolimus-based post-transplant cyclophosphamide.",[27,28,202,203,130,131,48,30,33],"Chronic Myelomonocytic Leukemia","Myelodysplastic Syndromes",[205,206,55,56,59,207,57,208,209,210,211,212,213],"GvHD","Allogeneic Stem Cell Transplant","CMML","HL","Cyclophosphamide","Thymoglobulin","Cyclosporin","Sirolimus","Mycophenolate Mofetil","2026-04-29",{"date":216,"type":65},"2026-05-05",{"date":218,"type":65},"2021-02-22",{"date":220,"type":20},"2027-08-23",{"name":222,"class":72},"University of Birmingham",17,{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":232,"conditions":233,"keywords":234,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":73},"100119058","chart-review-study-of-chronic-myelogenous-leukemia-cml-patients-treated-with-imatinib-outside-of-a-clinical-trial-100119058","NCT00816114","Chart Review Study of Chronic Myelogenous Leukemia (CML) Patients Treated With Imatinib Outside of a Clinical Trial","Inclusion Criteria:\n\nAll patients with CML in any phase of the disease (chronic, accelerated or blast phase) that has received treatment with any FDA-approved tyrosine kinase inhibitor (eg, imatinib, dasatinib, nilotinib) not on an MDACC clinical trial regardless of prior treatment history that has had at least one clinic visit at MDACC will be eligible.\n\nExclusion Criteria:\n\nN\u002FA",{"count":231,"type":20},3000,"In this study researchers propose to do a chart review of all patients that are treated outside of a clinical trial with imatinib, dasatinib, nilotinib, or any other tyrosine kinase inhibitor that becomes FDA approved for the managements of CML that come to MDACC for a second opinion. This is an important population of patients that differs in their management from patients treated in clinical trials for several reasons including but not limited to:\n\n1. It represents a very large patient population receiving standard-dose therapy with TKI. We estimate that we have evaluated over 300 patients that fall in this category.\n2. The follow-up for patients in the largest trial using standard-dose imatinib (the IRIS trial, with 553 patients in treated with imatinib) has been limited after the first 12 months. For example, the rate of molecular responses after the first 12 months of therapy was not obtained as samples stopped being collected at that time point.\n3. Registration studies for dasatinib and nilotinib have similar limitations with limited follow-up and available information coming only from databases from the sponsors to which there is limited access to investigate dosing, chronic toxicities, second malignancies and other important aspects of therapy.\n4. Patients who are or become pregnant during therapy with TKI have not been eligible for clinical trials with TKI or had to be taken off study. Thus, there is no information on the effect of TKI on imatinib on pregnancy and conception. We have followed several such patients at MDACC.\n5. This is a patient population that follows therapy mostly as directed by their local oncologists. This is frequently less stringently adhered to the recommended guidelines for TKI therapy, with more frequent treatment interruptions, and frequently using suboptimal doses of imatinib (i.e., less than 300mg daily). The effect of these treatment interruptions and suboptimal dosing on response and development of resistance is unclear.\n\nResearchers plan to conduct a chart review of these patients to study their treatment course before their initial evaluation at MDACC, and between and during visits to MDACC.",[30],[235,236,30,59],"Imatinib","Gleevec","2026-04-13",{"date":239,"type":65},"2026-04-16",{"date":241,"type":65},"2005-06-08",{"date":243,"type":20},"2030-04-30",{"name":245,"class":72},"M.D. Anderson Cancer Center",{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":16,"minAge":159,"maxAge":253,"enrollmentInfo":254,"targetDuration":158,"studyType":122,"phases":4,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":73},"100200817","the-prospective-collection-storage-and-reporting-of-data-on-patients-undergoing-hematopoietic-stem-cell-transplantation-utilizing-a-standard-preparative-regimen-100200817","NCT01890486","The Prospective Collection, Storage and Reporting of Data on Patients Undergoing Hematopoietic Stem Cell Transplantation Utilizing a Standard Preparative Regimen","The Prospective Collection, Storage and Reporting of Data on Patients","Inclusion Criteria:\n\nPlanned standard of care dose intensive therapy and either an allogeneic or autologous bone marrow transplant\n\nExclusion Criteria:\n\nParticipation in any other treatment research protocol","120 Years",{"count":255,"type":20},2000,"To provide the IRB approved mechanism for the prospective collection and analysis on participants who are undergoing either an autologous or allogeneic hematopoietic stem cell transplant for a disease in which a research question is not being addressed.",[128,127,30,258,259,48,260,203,37,261],"Non-Hodgkin's Lymphoma","Hodgkin's Disease","Germ Cell Neoplasms","Immunodeficiency Diseases","2026-04-09",{"date":237,"type":65},{"date":265,"type":65},"2001-05-21",{"date":267,"type":20},"2026-12",{"name":269,"class":72},"Wake Forest University Health Sciences",{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":16,"minAge":159,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":21,"phases":279,"briefSummary":281,"conditions":282,"keywords":4,"overallStatus":284,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":4},"100630598","phase-3-tgrx-678-chinese-phase-iii-in-chronic-myelogenous-leukemia-cml-patients-100630598","NCT07489755","TGRX-678 Chinese Phase III in Chronic Myelogenous Leukemia (CML) Patients","A Randomized, Open-label, Multi-center Phase III Study Evaluating Efficacy and Safety of TGRX-678 Comparing to Investigator Selected Tyrosine Kinase Inhibitor (TKI) in CML-CP Patients Resistant From or Intolerant to at Least 3 TKI Treatments","Inclusion Criteria:\n\n* Willing to consent and to follow study procedures\n* 18 years of age or above at time of screening; both sexes eligible\n* Diagnosed with CML-CP and was intolerant to or failed from at least 3 TKI treatments\n* ECOG score \\>= 2\n* Adequate hematological indicators and have not used blood products or Colony-Stimulating Factor (CSF)\n* Adequate kidney, liver and coagulation function\n* Adequate QTc interval as confirmed by electrocardiogram (ECG) test\n* Negative pregnancy result at screening for female patients of child-bearing potential\n* Willing to take contraceptive measure during the study (For male and female patients of child-bearing potential)\n\nExclusion Criteria:\n\n* Reception of TKI treatment or other anti-tumor treatments prior to first dose\n* History or presence of extramedullary leukemia\n* History of progression to CML-AP or BP\n* Presence or having uncontrolled condition for cardiovascular diseases\n* History of severe hemorrhagic disease\n* Presence of malabsorption or other conditions that may affect drug absorption\n* History of other primary malignancy within 5 years\n* Presence of continuous or active infection (including HIV, hepatitis B, hepatitis C)\n* In need for or having long-term immune suppressive treatment\n* Reception of major surgery 28 days before first dose\n* Presence of unrecovered toxicity due to anti-tumor treatment with CTCAE grade \\>=1\n* Presence of other conditions that the investigators or medical monitor deem unfit for the study",{"count":278,"type":20},180,[280],"PHASE3","A Phase III study evaluating the safety and efficacy of TGRX-678 in CML-CP patients resistant from or intolerant to at least 3 TKIs",[30,283],"Chronic Myelogenous Leukemia - Chronic Phase","NOT_YET_RECRUITING","2026-03-18",{"date":287,"type":65},"2026-03-24",{"date":289,"type":20},"2026-04-01",{"date":291,"type":20},"2031-05-01",{"name":293,"class":109},"Shenzhen TargetRx Co., Ltd.",{"id":295,"slug":296,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":301,"enrollmentInfo":302,"targetDuration":4,"studyType":21,"phases":304,"briefSummary":305,"conditions":306,"keywords":314,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":73},"100501157","phase-2-allo-hsct-using-ric-and-ptcy-for-hematological-diseases-100501157","NCT05805605","Allo HSCT Using RIC and PTCy for Hematological Diseases","Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning (RIC) With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases","Inclusion Criteria:\n\n* Age 0 to 75 years of age with Karnofsky score ≥ 70% (≥ 16 years) or Lansky score ≥ 50 (\\\u003C 16 years).\n* 5\u002F6 or 6\u002F6 related donor, OR a 7-8\u002F8 HLA-A, B, C, DRB1 allele match, OR a haplotype (at least 5\u002F10) matched related donor. Donors will be requested to provide PBSCs although bone marrow is acceptable according to donor preference.\n\nEligible Diseases Acute Leukemias: Must be in remission by morphology (≤5% blasts) AND without evidence of MRD by flow cytometry, FISH, or conventional cytogenetics. PCR based MRD detection is not an exclusion to proceed.\n\nAcute Myeloid Leukemia (AML) and related precursor neoplasms:\n\n2nd or greater complete remission (CR); first complete remission (CR1) in patients \\> 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk.\n\nFavorable risk AML is defined as having one of the following:\n\n* t(8,21) without cKIT mutation\n* inv(16) or t(16;16) without cKIT mutation\n* Normal karyotype with mutated NPM1 and wild type FLT-ITD (unless persistently NPM1 positive by PCR following two cycles of chemotherapy)\n* Normal karyotype with double mutated CEBPA\n* Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation\n\nAcute lymphoblastic Leukemia (ALL) \u002Flymphoma:\n\nCR2 or greater, CR1 unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1 high-risk ALL.\n\nHigh risk ALL is defined as having one of the following:\n\n* Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1\n* 30 years of age or older at diagnosis\n* White blood cell counts of greater than 30,000\u002FmcL (B-ALL) or greater than 100,000\u002FmcL (T-ALL) at diagnosis\n* CNS leukemia involvement during the course of disease\n* Slow cytologic response (\\>10% lymphoblasts in bone marrow on Day 14 of induction therapy)\n* Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy.\n\nVery high risk pediatric patients with ALL:\n\npatients \\\u003C21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieved a complete remission.\n\nBiphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias in first or subsequent CR.\n\nChronic Myelogenous Leukemia in chronic or accelerated phase, or CML blast crisis in morphological remission (\\\u003C5% blasts) and with negative MRD by flow cytometry (a positive PCR for BCRABL is acceptable for BMT): Chronic phase patients must have failed at least two different TKIs, been intolerant to all available TKIs or have T315I mutation. Patients with CML blast crisis in CR are only eligible if there is an feasible TKI maintenance plan following BMT.\n\nPlasma Cell Leukemia after initial therapy, who achieved at least a partial remission; or relapsed and achieved subsequent remission (CR\u002FPR) Myelodysplastic Syndrome: IPSS INT-2 or High Risk; R-IPSS High or Very High; WHO classification: RAEB-1, RAEB-2; Severe Cytopenias: ANC \\\u003C 0.8, Anemia or thrombocytopenia requiring transfusion; Poor or very poor risk cytogenetics based on IPSS or R-IPSS definitions; therapy-related MDS. Blasts must be \\\u003C 5% by bone marrow aspirate morphology. If ≥5% blasts, patient requires chemotherapy for cytoreduction to \\\u003C5% blasts prior to transplantation Leukemia or MDS in aplasia. These patients may be taken to transplant if after induction therapy they remain with aplastic bone marrow and no morphological or flow-cytometry evidence of disease ≥ 28 days post-therapy. These high risk patients will be analyzed separately.\n\nBurkitt's Lymphoma in CR2 or subsequent CR. Relapsed T-Cell Lymphoma that is chemotherapy sensitive in CR\u002FPR that has failed or ineligible for an autologous transplantNatural Killer Cell Malignancies. Relapsed Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma which have progressed within 12 months of achieving a partial or complete remission. Patients who had remissions lasting \\> 12 months, are eligible after at least two prior therapies. Patients with bulky disease should be considered for de-bulking chemotherapy before transplant. Patients with refractory disease may be eligible, unless bulky disease and an estimated tumor doubling time of less than one month.\n\nLymphoplasmacytic Lymphoma, Mantle-Cell Lymphomais eligible after initial therapy if chemotherapy sensitive.\n\nLarge Cell and other high risk NHL \\> CR2\u002F\\> PR2: Patients in CR2\u002FPR2 with initial short remission (\\\u003C6 months) are eligible.\n\nRelapsed Multiple Myeloma: that is chemotherapy sensitive and has failed or ineligible for an autologous transplant.\n\nMyeloproliferative Neoplasms\u002FMyelofibrosis - with transfusion dependence or expected survival under 5 years by DIPSS, DIPSS-plus, or MPSS70 calculator.\n\nAcquired Bone Marrow Failure Syndromes except for Fanconi anemia Other Leukemia Subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.\n\nAdditional Criteria for Bulky Disease (lymphomas) if stable disease is best response, the largest residual nodal mass must \\\u003C 5 cm (approximately) If response to previous therapy, the largest residual mass must represent a 50% reduction and be \\\u003C 7.5 cm (approximately)\n\nOrgan Function Criteria\n\nAdequate organ function is defined as:\n\nLiver: Transaminases ≤ 5 x upper limit of normal (ULN) and total bilirubin ≤ 2.5 mg\u002FdL except for patients with Gilbert's syndrome or hemolysis.\n\nRenal: A normal creatinine (adults) or creatinine clearance ≥ 40 mL\u002Fmin (pediatrics). Adults with a creatinine \\> 1.2 mg\u002Fdl or a history of renal dysfunction must have estimated GFR ≥ 40 ml\u002Fmin\u002F1.73m2.\n\nCardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \\> 40%. For children that are not able to cooperate with MUGA and echocardiography, such should be clearly stated in the physician's note.\n\nPulmonary: DLCO, FEV1, FVC ≥ 40% predicted, and absence of O2 requirements. For children that are not able to cooperate with PFTs, a pulse oximetry with exercise should be attempted. If neither test can be obtained it should be clearly stated in the physician's note.\n\nIf recent confirmed mold infection (e.g. aspergillus) must have minimum of 30 days of therapy and responsive disease and be cleared by Infectious Disease HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation Sexually active females of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control during study treatment Voluntary written consent (adult or parent\u002Fguardian with presentation of the minor information sheet, if appropriate)\n\nRelated donors will be evaluated and collected according to UMN BMT program standard processes. Unrelated donors will be identified and collected through the National Marrow and Donor Program (NMDP) per usual steps.\n\nExclusion Criteria:\n\n* Pregnant or breast feeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.\n* Untreated active infection\n* Active central nervous system malignancy\n* CML in blast crisis\n* Intermediate or high grade NHL, mantle cell NHL, and Hodgkin disease that is progressive on salvage therapy. Stable disease is acceptable to move forward provided it is non-bulky.\n* Less than 3 months since prior myeloablative transplant\n* Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.","75 Years",{"count":303,"type":20},56,[23],"This is a Phase II study following subjects proceeding with our Institutional non-myeloablative cyclophosphamide\u002F fludarabine\u002Ftotal body irradiation (TBI) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion using post-transplant cyclophosphamide (PTCy), sirolimus and MMF GVHD prophylaxis.",[128,127,307,308,43,30,31,203,309,310,46,311,312,38,313,40,129,33],"Biphenotypic Acute Leukemia","Undifferentiated Leukemia","Leukemia, Myeloid","Myelodysplastic Syndrome With Excess Blasts-1","Relapsed T-Cell Lymphoma","Relapsed Chronic Lymphocytic Leukemia","Marginal Zone Lymphoma",[56,58,60,55,59,315,316,317,318,319,320,16],"PFS","TRM","GVHD","MMF","TBI","PTCy","2025-06-27",{"date":323,"type":65},"2025-07-01",{"date":325,"type":65},"2023-05-01",{"date":327,"type":20},"2028-10-22",{"name":71,"class":72},{"id":330,"slug":331,"hasResults":11,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":11,"sex":16,"minAge":159,"maxAge":336,"enrollmentInfo":337,"targetDuration":4,"studyType":21,"phases":339,"briefSummary":340,"conditions":341,"keywords":344,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":73},"100568395","phase-2-abba-cord-dcbt-w-abatacept-for-agvhd-prophylaxis-100568395","NCT06680661","ABBA CORD: dCBT w\u002F Abatacept for aGVHD Prophylaxis","ABBA CORD: Double Umbilical Cord Blood Transplants With Abatacept for Graft Versus Host Disease Prophylaxis","Inclusion Criteria:\n\n* Patients with the following hematologic malignancies:\n\n  * Acute myelogenous leukemia (AML): High-risk and intermediate-risk AML including:\n\n    * Antecedent hematological disease (e.g., myelodysplasia (MDS))\n    * Treatment-related leukemia\n    * Complete Remission (CR1) with poor or intermediate-risk cytogenetics or molecular markers (e.g. Flt 3 mutation, 11q23, del 5, del 7, complex cytogenetics)\n    * CR2 or CR3\n    * Induction failure or 1st relapse with \\\u003C 10% blasts in the marrow\n  * Acute lymphoblastic leukemia (ALL):\n\n    * High-risk CR1 including:\n\n      * Poor-risk cytogenetics (e.g., Philadelphia chromosome t(9;22)or 11q23 rearrangements)\n      * Philadelphia chromosome-like ALL\n      * Presence of minimal disease by flow cytometry after 2 or more cycles of chemotherapy\n    * No CR within 4 weeks of initial treatment\n    * Induction failure with \\\u003C 10% blasts in the marrow\n    * CR2 or CR3\n  * Myelodysplastic syndromes (MDS), Intermediate, High or Very High Risk by the revised international prognostic scoring system or treatment related MDS.\n  * Bi-phenotypic or mixed-phenotypic acute leukemia in:\n\n    * CR.\n    * Induction failure or 1st relapse with \\\u003C 10% blasts in the marrow.\n  * Chronic Myelogenous Leukemia (CML) in second chronic phase after accelerated or blast crisis.\n  * Chronic Myelomonocytic Leukemia (CMML)\n  * Hodgkin's Lymphoma that is relapsed or refractory\n* Age \\> or equal to 18 years, \\\u003C or equal to 70yrs\n* KPS \\> or equal to 80 for Flu\u002FCy\u002FThio\u002FTBI; KPS \\> 60 for Flu\u002FTreo\u002FTBI\n* Patients without a suitable HLA-matched related or unrelated donor\n* Patient with the following CB units:\n\n  * At least two 4-8\u002F8 HLA high resolution matched CB units. Both must have a cell dose of 1.5x107 TNC\u002Fkg each and 1.5x105 CD34+\u002Fkg\n  * A minimum of 1 CB unit as back up.\n* Concurrent Therapy for Extramedullary Leukemia or CNS Lymphoma: Concurrent therapy or prophylaxis for testicular leukemia, CNS leukemia, and CNS lymphoma including standard intrathecal chemotherapy and\u002For radiation therapy will be allowed as clinically indicated. Such treatment may continue until the planned course is completed. Subjects must be in CNS remission at the time of protocol enrollment if there is a history of CNS involvement. Maintenance therapy after transplant is allowed.\n* Subjects must have the ability to understand and the willingness to sign a written informed consent document.\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year during the treatment period and for 12 months after the last dose of abatacept.\n* A woman is considered to be of childbearing potential if she is \\\u003C 60 years old, postmenarcheal, has not reached a postmenopausal state (\\\u003C 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus).\n\n  * Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n\nThe reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures with female partners of reproductive potential, and agreement to refrain from donating sperm, as defined below:\n\n  * With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for 12 months after the last dose of abatacept. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 12 months after the last dose of abatacept.\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n\nExclusion Criteria:\n\n* Patients with inadequate Organ Function as defined by:\n\n  * Creatinine clearance \\\u003C 50ml\u002Fmin\n  * Bilirubin \\> 2X institutional upper limit of normal unless Gilbert syndrome\n  * AST (SGOT) \\> 3X institutional upper limit of normal\n  * ALT (SGPT) \\> 3X institutional upper limit of normal\n  * Pulmonary function: DLCOc \\\u003C 60% normal\n  * Cardiac: left ventricular ejection fraction \\\u003C 50\n* Patients with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant or breastfeeding women are excluded from this study because chemotherapy involved with RIC have the significant potential for teratogenic or abortifacient effects.\n* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.\n* Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.\n* Presence of donor-specific antibodies against chosen graft source.\n* Hematopoietic Cell Transplantation Comorbidity index (HCT-CI) \\> 5.\n* Prior autologous or allogenic stem cell transplant within the preceding 12 months.","65 Years",{"count":338,"type":20},20,[23],"The goal of this clinical trial is to see if adding abatacept to tacrolimus and MMF prevents or reduces the chances of acute graft versus host disease which is a complication that can occur after transplant in participants with blood cancer. The usual therapy for graft versus host disease prevention after a cord blood transplant includes tacrolimus and MMF. The main question this clinical trial aims to answer is whether or not abatacept will be safe and effective in reducing aGVHD rates in dCBT.\n\nParticipants will:\n\n* Partake in exams, tests, and procedures as part of usual cancer care.\n* Partake in conditioning, which is the treatment that is given before a transplant.\n* Have a cord blood transplant.\n* Partake in radiation following the transplant.",[128,342,30,203,343,202,29,131],"Acute Lymphatic Leukemia","Myelodysplastic Syndrome Other",[345,346,347,348],"Chronic Myelomonocytic Lymphoma","Umbilical Cord Blood Transplant","Double Umbilical Cord Transplant","Cord blood","2025-06-02",{"date":351,"type":65},"2025-06-04",{"date":353,"type":65},"2025-02-25",{"date":355,"type":20},"2028-10-31",{"name":357,"class":72},"Leland Metheny",{"id":359,"slug":360,"hasResults":11,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":11,"sex":16,"minAge":159,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":21,"phases":367,"briefSummary":369,"conditions":370,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":379},"100522920","phase-1-tgrx-678-us-phase-i-for-subjects-with-refractory-or-advanced-chronic-myelogenous-leukemia-100522920","NCT06088888","TGRX-678 US Phase I for Subjects with Refractory or Advanced Chronic Myelogenous Leukemia","A Single-arm, Open-label, Dose Escalation + Cohort Expansion Phase 1 Trial on Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TGRX-678 in Subjects with Refractory or Advanced Chronic Myelogenous Leukemia","Inclusion Criteria:\n\n* Willing to participate in the study with informed consent;\n* At least 18 years of age at the time of screening;\n* Any sex;\n* Diagnosis of CML-CPduring the screening period;\n* Intolerant or resistant to TKI treatments;\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;\n* Adequate Absolute neutrophil count (ANC), hemoglobin and platelets levels;\n* Adequate renal and liver function;\n* Normal corrected QT (QTcF) interval as indicated by electrocardiogram (ECG) screening results;\n* Negative blood pregnancy test results for female patients of childbearing potential.\n* Willing to take highly effective contraceptive measures throughout the trial and for 6 months after last dose of investigational drug for female subjects of child-bearing potential or male subject with female partner of child-bearing potential.\n\nExclusion Criteria:\n\n* Exposure to other antineoplastic therapies prior to study enrollment;\n* Exposure to other investigational agent(s) within 14 days of initiating TGRX-678 therapy;\n* Ongoing toxicity from prior therapy greater than grade 1 by CTCAE v. 3 (except alopecia);\n* Hematopoietic cell transplantation \\\u003C 60 days prior to the first dose;\n* Evidence of graft versus host disease (GVHD), whether or not requiring immunosuppressive therapy;\n* Concomitant immunosuppressive therapy (other than short-term corticosteroid treatment);\n* Exposure to drugs related to torsade de pointes;\n* Cytological or pathological diagnosis of active central nervous system disorder;\n* Significant or uncontrolled cardiovascular diseases as defined in the full clinical protocol;\n* Having long QT syndrome, or with family history of idiopathic sudden death or congenital long QT syndrome;\n* Uncontrolled hypertension;\n* Receipt of Traditional Chinese medication or herbal preparations indicated for anti-cancer purposes within 2 weeks prior to the first dose;\n* Severe hemorrhagic disorders unrelated to CML;\n* History of pancreatitis;\n* History of excessive alcohol use;\n* History of elevation in amylase or lipase within 1 year;\n* Have Grade 2 or worse interstitial lung disease or interstitial pneumonitis within 4 weeks prior to Screening;\n* Uncontrolled hypertriglyceridemia;\n* Malabsorption syndrome or other illness that could affect oral absorption.\n* Diagnosis of another primary malignancy in the past 3 years;\n* Reception of major surgery within 14 days prior to the first dose;\n* Active infections that require systemic treatment or other severe infections within 14 days prior to enrollment;\n* Known human immunodeficiency virus (HIV) positive; acute or chronic liver disease (including chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) infections);\n* Have received or will receive a COVID-19 vaccine within 14 days of study enrollment;\n* Have a positive reverse transcriptase polymerase chain reaction (RT-PCR) test result for SARS-CoV-2 within 2 weeks prior to Screening;\n* Pregnant or breastfeeding female;\n* Female patient of child-bearing potential or male patient who have female partners of child-bearing potential that is unable or unwilling to take highly effective contraceptive measures during the trial and for 6 months after last dose of investigational drug;\n* Significant organ dysfunction that could compromise the patient's safety or the evaluation of the drug's safety in the opinion of the investigator or the medical monitor;\n* Any condition makes participation in this trial inappropriate in the opinion of the investigator or medical monitor;",{"count":366,"type":20},90,[368],"PHASE1","The purpose of this single-arm, open-label, dose escalation + cohort expansion study is to evaluate the safety, tolerability, pharmacokinetic and preliminary efficacy of TGRX-678 in Chronic Myelogenous Leukemia patients who had failure with or are intolerant to TKI treatments.",[30],"2025-02-19",{"date":373,"type":65},"2025-02-21",{"date":375,"type":65},"2024-07-02",{"date":377,"type":20},"2027-06-30",{"name":293,"class":109},2,{"id":381,"slug":382,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":11,"sex":16,"minAge":159,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":21,"phases":389,"briefSummary":390,"conditions":391,"keywords":4,"overallStatus":284,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":398,"locationsCount":150},"100567751","phase-1-a-clinical-trial-to-evaluate-the-safety-and-tolerability-of-tqb3911-tablets-in-patients-with-bcrabl-fusion-gene-positive-leukemia-100567751","NCT06672263","A Clinical Trial to Evaluate the Safety and Tolerability of TQB3911 Tablets in Patients With BCR::ABL Fusion Gene Positive Leukemia","Phase I Clinical Trial to Evaluate the Safety and Tolerability of TQB3911 Tablets in Patients With BCR::ABL Fusion Gene Positive Leukemia","Inclusion Criteria:\n\n* The subjects voluntarily joined the study, signed the informed consent, and had good compliance;\n* Age: ≥18 years old (when signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-2; Expected survival of more than 3 months;\n* During the screening period, the patients were identified as Chronic myelogenous leukemia-Chronic phase (CML-CP) or accelerated phase (AP) patients by bone marrow cell morphological examination, molecular biological examination or cytogenetic examination;\n* Chronic myelogenous leukemia (CML) patients who are intolerant to Tyrosine kinase inhibitors (TKI) drugs or whose therapeutic effect is not satisfactory (that is, the therapeutic response evaluation result is failure)\n* The main organs function well\n* Female subjects of reproductive age should agree to use contraceptives (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male subjects should agree to use avoidance during the study period and for 6 months after the end of the study period.\n\nExclusion Criteria:\n\n* Had or was currently suffering from other malignant tumors within 5 years before the first medication\n* Combined with active central nervous system leukemia\n* Major surgical treatment and significant traumatic injury were received within 28 days before the start of study treatment\n* Previous history of myocardial infarction, pulmonary hypertension, or angina pectoris within 3 months before the first medication, or clinically significant arrhythmias such as ventricular tachycardia, complete left bundle branch block, and high atrioventricular block\n* Acute pancreatitis and a history of chronic pancreatitis within 12 months before the first medication\n* History of interstitial lung disease, radiation pneumonia requiring steroid treatment, or drug-related pneumonia\n* Patients with CML-CP who have achieved complete cytogenetic response (CCyR)\n* Received live attenuated vaccine within 4 weeks before the first dose, or planned to receive live attenuated vaccine during study participation\n* Use of drugs that may have caused QT prolongation or tip torsical tachycardia in the 7 days prior to initial administration, or continuation of these medications during the study period",{"count":388,"type":20},120,[368],"Phase I clinical trial to explore the safety, tolerability, and initial efficacy of TQB3911 tablets in BCR::ABL fusion gene positive leukemia.",[30],"2024-10-31",{"date":394,"type":65},"2024-11-04",{"date":396,"type":20},"2024-11",{"date":267,"type":20},{"name":399,"class":109},"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.",{"id":401,"slug":402,"hasResults":11,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":11,"sex":16,"minAge":159,"maxAge":301,"enrollmentInfo":407,"targetDuration":4,"studyType":21,"phases":409,"briefSummary":410,"conditions":411,"keywords":414,"overallStatus":284,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":423,"leadSponsor":425,"locationsCount":4},"100556876","phase-1-study-of-hs-10382-combination-in-patients-with-chronic-myeloid-leukemia-cml-100556876","NCT06530810","Study of HS-10382 Combination in Patients With Chronic Myeloid Leukemia (CML)","A Phase 1b, Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10382 Combination Therapy in Patients With Chronic Myeloid Leukemia","Inclusion Criteria:\n\n* Signed informed consent form.\n* Men or women aged more than or equal to (≥) 18 years, and less than (\\\u003C) 75 years.\n* CML-CP\u002FAP patients with the Ph chromosome or BCR-ABL1 fusion genes.\n* Patient with CML-CP\u002FAP who are resistant to or intolerant to previous TKIs therapy.\n* ECOG performance status of 0-1 and no worsening within 2 weeks before the first dose.\n* Life expectancy ≥ 12 weeks.\n* Men or women should be using adequate contraceptive measures throughout the study; Females should not be breastfeeding at the time of screening, during the study and until 6 months after completion of the study.\n* Females must have evidence of non-childbearing potential.\n\nExclusion Criteria:\n\n* CML-CP patients who have acquired CCyR and have not lost it.\n* Patients with CML-CP who have progressed to AP or blast phase(BP.)\n* Patients with CML-AP who have obtained CHR or no evidence of CML in peripheral blood.\n* Patients with CML-AP who have progressed to BP.\n* Previous treatment with a BCR-ABL1 TKI allosteric inhibitor .\n* Impaired cardiac function including any one of the following:\n* Resting corrected QT interval (QTc) \\> 470 ms obtained from electrocardiogram (ECG), using the screening clinic's ECG machine and Fridericia's formula for QT interval correction (QTcF).\n* Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG.\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events,\n* Left ventricular ejection fraction (LVEF) ≤ 50%.\n* Myocardial infarction occurred within 6 months of the first scheduled dose of study drug.;\n* Congestive heart failure occurred within 6 months of the first scheduled dose of study drug.;\n* Uncontrollable angina.\n* History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis\n* Any severe or uncontrolled systemic diseases (i.e. uncontrolled hypertension or diabetes).\n* Clinically severe gastrointestinal dysfunction that may affect drug intake, transport or absorption.\n* Severe infection within 4 weeks prior to the first scheduled dose of study drug\n* Inadequate other organ function.\n* History of other malignancies.\n* History of hypersensitivity to any active or inactive ingredient of HS-10382 and flumatinib.\n* History of neuropathy or mental disorders, including epilepsy and dementia.\n* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements",{"count":408,"type":20},100,[368],"HS-10382 is a small molecular, oral potent, allosteric inhibitor. By binding a myristoyl site of the BCR-ABL1 protein, HS-10382 locks BCR-ABL1 into an inactive conformation. Flumatinib is the first approved second generation TKI in China and a derivative of imatinib.\n\nThe primary objective of this study is to evaluation the safety and tolerability and of HS-10382 combination therapy in patients with chronic myeloid leukemia (CML).\n\nThe secondary objectives is to evaluate the PK profile, major metabolites and efficacy of HS-10382 in CML-CP\u002FAP subjects after combination therapy, and to explore the kinase domain mutations associated with TKI resistance",[30,412,413],"CML Chronic Phase","CML Accelerated Phase",[415,416,417,418],"CML-CP\u002FAP","HS-10382","Flumatinib","Allosteric inhibitor","2024-07-26",{"date":421,"type":65},"2024-07-31",{"date":421,"type":20},{"date":424,"type":20},"2028-05-08",{"name":426,"class":109},"Jiangsu Hansoh Pharmaceutical Co., Ltd."]