[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-myelomonocytic-leukemia-cmml\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-myelomonocytic-leukemia-cmml":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,43,76,114,151,187,206],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100640823","thiotepa-containing-conditioning-regimen-for-allogeneic-hsct-in-chronic-myelomonocytic-leukemia-100640823",false,"NCT07588594","Thiotepa-Containing Conditioning Regimen for Allogeneic HSCT in Chronic Myelomonocytic Leukemia","Prospective Single-Arm Clinical Study of Thiotepa-Containing Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation in Chronic Myelomonocytic Leukemia","Inclusion Criteria:\n\n* Age ≥ 18 years, any sex\u002Fgender.\n* Confirmed diagnosis of chronic myelomonocytic leukemia (CMML) according to the 2022 WHO classification.\n* Intermediate-2 or high-risk CMML based on CPSS or CPSS-mol score, and planned to receive allo-HSCT.\n* Has a suitable hematopoietic stem cell donor:\n* For haploidentical donor: at least 5\u002F10 HLA match at HLA-A, -B, -C, -DQB1, and -DRB1.\n* For unrelated donor: at least 9\u002F10 HLA match at the same five loci.\n* For matched sibling donor: 10\u002F10 HLA match at the same five loci.\n* Hematopoietic cell transplantation comorbidity index (HCT-CI) ≤ 2, with generally good health and no significant organ abnormalities or major comorbidities.\n* Adequate organ function as defined below:\n* Left ventricular ejection fraction (LVEF) ≥ 50%, and no uncontrolled tachycardia or bradycardia-tachycardia syndrome.\n* Total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT ≤ 2 × ULN; AST ≤ 2 × ULN.\n* Serum creatinine ≤ 1.5 × ULN.\n* Baseline oxygen saturation \\> 92%.\n* Pulmonary function: DLCO (corrected for hemoglobin) ≥ 40%, FEV1 ≥ 50%.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* Agrees not to participate in any other interventional study during the treatment period.\n* Willing and able to provide written informed consent, understand the nature, purpose, and procedures of the study, and voluntarily comply with study requirements.\n\nExclusion Criteria:\n\n* Previous allogeneic HSCT for CMML that later relapsed.\n* Unwilling or unable to receive the study treatment regimen.\n* Active hepatitis B or C, or chronic active hepatitis; known human immunodeficiency virus (HIV) infection.\n* Active uncontrolled infection, including: hemodynamic instability related to infection, new or worsening signs\u002Fsymptoms of infection, new infection lesions on imaging, or persistent fever without explanation despite no symptoms\u002Fsigns.\n* History of stroke or intracranial hemorrhage within 6 months before enrollment.\n* Known pregnancy (positive urine pregnancy test), or currently breastfeeding.\n* Diagnosis of another malignancy within the past 2 years, except for localized skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, breast cancer, or localized prostate cancer (Gleason score ≤ 6) that has been treated with curative intent.\n* Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.","ALL","18 Years",{"count":19,"type":20},31,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is a prospective, single-arm clinical study. It aims to evaluate the effectiveness and safety of a conditioning regimen containing thiotepa (in combination with busulfan and fludarabine, with or without ATG) of allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with chronic myelomonocytic leukemia (CMML) who have an intermediate-2 or high-risk prognosis.\n\nThe main goal is to evaluate 1 year RFS and OS. Other goals include assessing engraftment, overall survival, transplant-related complications, and side effects. A total of 31 participants will be enrolled.",[26],"Chronic Myelomonocytic Leukemia (CMML)",[26,28,29],"Hematopoietic Stem Cell Transplantation (HSCT)","Thiotepa","RECRUITING","2026-05-21",{"date":33,"type":34},"2026-05-26","ACTUAL",{"date":36,"type":34},"2026-02-13",{"date":38,"type":20},"2028-05",{"name":40,"class":41},"Peking University People's Hospital","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":63,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":42},"100616220","phase-1-tacrolimus-targeted-immunosuppression-cessation-in-allogeneic-hct-100616220","NCT07302776","TACrolimus Targeted Immunosuppression Cessation in ALlogeneic HCT","TACTICAL: TACrolimus Targeted Immunosuppression Cessation in ALlogeneic HCT","Inclusion Criteria:\n\n* Eligible diseases:\n\n  * Acute myeloid leukemia (AML) in complete remission (CR), CR with incomplete hematologic recovery (CRi), or MLFS.\n  * Myelodysplasic syndrome (MDS) myelodysplastic syndromes eligible for alloHSCT based on IPSS-M of intermediate or higher, or IPSS-R of intermediate or higher, or refractory disease to standard growth factor or hypomethylating agent-based therapy\n  * Myelofibrosis (MF)\n  * Chronic myeloid leukemia (CML) in chronic phase with a prior history of accelerated phase or blast crisis or CML in chronic phase refractory to standard TKI therapy\n  * Chronic myelomonocytic leukemia (CMML)\n* Age ≥ 18 and ≤ 80 years at the time of enrollment.\n* Planned for first myeloablative or reduced intensity allogenic transplant using a conditioning regimen listed in Appendix B.\n* Has a related or unrelated donor available who is 8\u002F8 HLA match at HLA-A, -B, -C, and -DRB1, all typed using DNA-based high-resolution methods.\n* Estimated glomerular filtration rate (eGFR) ≥ 50 mL\u002Fminute or creatinine \\\u003C 2 mg\u002FdL.\n\nCardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA).\n\n* Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%.\n* Total bilirubin \\\u003C 2 times upper limit of normal (ULN) (patients with Gilbert's syndrome may be included once hemolysis has been excluded).\n* Karnofsky Performance Score ≥70%\n* Negative serum or urine beta-HCG test in females of childbearing potential (FCBP) within 3 weeks of enrollment.\n\nA female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).\n\n-Ability to understand and the willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Prior allogeneic HCT.\n* Planned donor lymphocyte infusion (DLI).\n* Recipient positive anti-donor HLA antibodies against a mismatched allele in the selected donor determined by either:\n\n  1. Positive crossmatch test of any titer (by complement-dependent cytotoxicity or flow cytometric testing), or\n  2. Presence of anti-donor HLA antibody to any of the following HLA loci: HLA-A, -B, -C, -DRB1, -DQB1, -DQA1, -DPB1, or -DPA1, with mean fluorescence intensity (MFI) \\>1000 by solid phase immunoassay.\n* Uncontrolled bacterial, viral, or fungal infections at time of enrollment including known, active tuberculosis infection.\n* Seropositive for HIV-1 or -2, HTLV-1 or -2, Hepatitis B sAg, and\u002For Hepatitis C antibody.\n\n  \\*History of hepatitis B or hepatitis C is permitted if viral load is undetectable per quantitative PCR and\u002For NAT.\n\nKnown allergy or hypersensitivity to planned GVHD prophylactic medications including PTCy, tacrolimus\n\n* Any uncontrolled autoimmune disease requiring active immunosuppressive treatment.\n* Concurrent malignancy diagnosed within 12 months of enrollment, except non-melanoma skin cancers or other early-stage solid tumors that have been curatively resected or treated to curative intent. Patients with history of low grade concurrent blood cancers that are controlled will be eligible.\n* Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use effective forms of birth control or abstinence for one year after transplantation.\n\n(FCBP definition: A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).\n\n-Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the recipient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results.\n\n\\* All subject files must include supporting documentation to confirm subject eligibility.","80 Years",{"count":52,"type":20},50,[54],"PHASE1","The purpose of this study is to test the feasibility and safety of early cessation of tacrolimus following allogeneic hematopoietic cell transplantation (HCT). Post-HCT tacrolimus is given to prevent graft-vs-host-disease (GVHD), but with the use of post-transplant cyclophosphamide (PTCy), the modern approach to GVHD prevention, GVHD rates have reduced markedly.",[57,58,59,60,61,62,26],"GVHD","Hematopoietic Cell Transplantation (HCT)","Acute Myeloid Leukemia (AML)","Myelodysplastic Syndromes","Myelofibrosis (MF)","Chronic Myeloid Leukemia (CML)",[64,65],"Post-Hematopoietic Cell Transplant (HCT) tacrolimus","hematopoietic cell transplantation (HCT)","NOT_YET_RECRUITING","2026-04-14",{"date":69,"type":34},"2026-04-17",{"date":71,"type":20},"2026-06",{"date":73,"type":20},"2028-02",{"name":75,"class":41},"Stanford University",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":88,"conditions":89,"keywords":100,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":113},"100582139","phase-2-a-platform-protocol-to-investigate-post-transplant-cyclophosphamide-based-graft-versus-host-disease-prophylaxis-in-patients-with-hematologic-malignancies-undergoing-mismatched-unrelated-donor-peripheral-blood-stem-cell-transplantation-100582139","NCT06859424","A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation","ACCELERATE","Inclusion Criteria, MAC RECIPIENTS:\n\n1. Age 18 to \\\u003C 66 years (chemotherapy-based conditioning) or \\\u003C 61 years (TBI-based conditioning) at the time of signing informed consent\n2. Patient or legally authorized representative has the ability to provide informed consent according to the applicable regulatory and institutional requirements\n3. Stated willingness to comply with all study procedures and availability for the duration of the study\n4. Planned MAC regimen (see Table 8 in Section 7.4 for allowed MAC regimens)\n5. Available partially HLA-MMUD (4\u002F8-7\u002F8 at HLA-A, -B, -C, and -DRB1 is required) with age 16-35\n6. Product planned for infusion is MMUD T-cell replete PBSC as allograft\n7. HCT-CI \\\u003C 5 (Appendix H - Hematopoietic Cell Transplant Comorbidity Index Scoring). The presence of prior malignancy will not be used to calculate HCT-CI for this trial, to allow for the inclusion of patients with secondary or therapy-related AML or MDS.\n8. One of the following diagnoses:\n\n   1. AML, ALL, or other acute leukemia in first remission or beyond with ≤ 5% marrow blasts and no circulating blasts or evidence of extramedullary disease. Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning.\n   2. Patients with MDS with no circulating blasts and with \\\u003C 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with \\\u003C 5% vs 5-10% blasts in MDS). Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning.\n9. Cardiac function: Left ventricular ejection fraction ≥ 45% based on most recent echocardiogram or multi-gated acquisition scan (MUGA) results\n10. Estimated creatinine clearance ≥ 45mL\u002Fmin calculated by equation\n11. Pulmonary function: diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin ≥ 50% and forced expiratory volume in first second (FEV1) predicted ≥ 50% based on most recent PFT results\n12. Liver function acceptable per local institutional guidelines\n13. KPS of ≥ 70% (Appendix I - Performance Status)\n\nInclusion Criteria, RIC\u002FNMA RECIPIENTS:\n\n1. Age ≥ 18 years at the time of signing informed consent\n2. Patient or legally authorized representative has the ability to provide informed consent according to the applicable regulatory and local institutional requirements\n3. Stated willingness to comply with all study procedures and availability for the duration of the study\n4. Planned NMA\u002FRIC regimen (see\n5. Table 9 in Section 7.4 for allowed NMA\u002FRIC regimens)\n6. Available partially HLA-MMUD (4\u002F8-7\u002F8 at HLA-A, -B, -C, and -DRB1 is required) with age 16-35\n7. Product planned for infusion is MMUD T-cell replete PBSC allograft\n8. One of the following diagnoses:\n\n   1. Patients with acute leukemia or chronic myeloid leukemia (CML) with no circulating blasts, no evidence of extramedullary disease, and with \\\u003C 5% blasts in the bone marrow. Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning.\n   2. Patients with MDS with no circulating blasts and with \\\u003C 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with \\\u003C 5% vs 5-10% blasts in MDS.) Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning.\n   3. Patients with chronic lymphocytic leukemia (CLL) or other leukemias (including prolymphocytic leukemia) with chemosensitive disease at time of transplantation.\n   4. Higher-risk chronic myelomonocytic leukemia (CMML) according to CMML-specific prognostic scoring system or high-risk MDS\u002Fmyeloproliferative neoplasms (MPN) not otherwise specified are eligible, provided there is no evidence of high-grade bone marrow fibrosis or massive splenomegaly at the time of enrollment.\n   5. Patients with lymphoma with chemosensitive disease at the time of transplantation.\n   6. Patients with primary myelofibrosis or myelofibrosis secondary to essential thrombocythemia, polycythemia vera or MDS with grade 4 fibrosis.\n9. Cardiac function: Left ventricular ejection fraction ≥ 40% based on most recent echocardiogram or MUGA results with no clinical evidence of heart failure\n10. Estimated creatinine clearance ≥ 45mL\u002Fmin calculated by equation\n11. Pulmonary function: DLCO corrected for hemoglobin ≥ 50% and FEV1 predicted ≥ 50% based on most recent PFT results\n12. Liver function acceptable per local institutional guidelines\n13. KPS of ≥ 60% (Appendix I - Performance Status)\n\nExclusion Criteria:\n\n1. Suitable HLA-matched related or 8\u002F8 high-resolution matched unrelated donor available\n2. Subject unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing\n3. Subjects with a prior allogeneic transplant\n4. Subjects with an autologous transplant within the past 3 months\n5. Subjects who are breastfeeding or pregnant\n6. Uncontrolled bacterial, viral or fungal infection at the time of the transplant preparative regimen\n7. Concurrent enrollment on a GVHD prevention clinical trial\n8. Subjects who undergo desensitization to reduce anti-donor HLA antibody levels prior to transplant\n9. Patients who are HIV-positive with persistently positive viral load. HIV-infected patients on effective anti-retroviral therapy (ART) with undetectable viral load within 6 months are eligible for this trial. Patients with well-controlled HIV are eligible provided resistance panels are negative, the patient is compliant with ART, and their disease remains well controlled.","66 Years",{"count":85,"type":20},358,[87],"PHASE2","The purpose of this clinical trial is to compare drug combinations to learn which drugs work best to prevent graft-versus-host-disease (GVHD) in people who have received a stem cell transplant. The source of stem cells is from someone who is not related and has a different blood cell type than the study participant. The researchers will compare the new drug combination to a standard drug combination. They will also learn about the safety of each drug combination.\n\nParticipants will:\n\n* Receive the standard or new drug combination after transplant\n* Visit the doctor's office for check-ups and tests after transplant that are routine for most transplant patients\n* Take surveys about physical and emotional well-being\n* Give blood and stool samples.",[90,91,92,93,94,95,96,26,97,98,99],"AML (Acute Myelogenous Leukemia)","Acute Lymphoid Leukemia (ALL)","Acute Leukemia (Category)","MDS (Myelodysplastic Syndrome)","CML (Chronic Myelogenous Leukemia)","CLL (Chronic Lymphocytic Leukemia)","Prolymphocyctic Leukemia","Myeloproliferative Neoplasm (MPN)","Lymphoma","Myelofibrosis",[81,101,102],"ACCEL-001","ACCEL-002","2026-03-16",{"date":105,"type":34},"2026-03-17",{"date":107,"type":34},"2025-07-25",{"date":109,"type":20},"2028-06",{"name":111,"class":112},"Center for International Blood and Marrow Transplant Research","NETWORK",13,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":122,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":126,"conditions":127,"keywords":131,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":150},"100592534","phase-1-a-study-of-cbx-250-in-participants-with-relapsed-or-refractory-myeloid-leukemias-100592534","NCT06994676","A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias","CROSSCHECK-001: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate Safety, Tolerability, and Clinical Activity of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias","CROSSCHECK-001","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\nAge\n\n1. Dose Escalation: Male or female participants aged ≥18 years.\n2. Backfill Cohorts: Male or female participants aged ≥12 years for whom no curative treatment options, including transplantation, are available.\n\n   Diagnosis \\& Disease Characteristics\n3. Participants with histological confirmation of advanced hematologic malignancy including:\n\n   1. R\u002FR AML, as defined by standardized criteria (e.g., European LeukemiaNet criteria \\[Dohner 2022\\]; after standard of care therapy. Participants with persistent leukemia after initial therapy or with recurrence of leukemia at any time after achieving a response during or after the course of treatment (including HSCT) are eligible.\n   2. R\u002FR HR-MDS or very high risk MDS as per the Revised International Prognostic Scoring System (IPSS-R; Greenberg 2012) or Molecular International Prognostic Scoring System (IPPS-M, Bernard 2022) who are resistant or refractory to 4-6 cycles of hypomethylating agents (HMA; decitabine or azacitidine).\n   3. R\u002FR CMML who are resistant or refractory to 4-6 cycles of hypomethylating agents (HMA; decitabine or azacitidine).\n4. White blood cells must be below 25,000\u002FµL at time of enrollment. Participants may receive cytoreduction prior to enrollment.\n5. Historical documented evidence of HLA-A\\*02:01 allele positivity.\n\n   Performance Level\n6. ECOG PS score 0-1 (if aged ≥18 years); Karnofsky Performance Scale of ≥70 (if aged ≥16 years and \\\u003C18 years); Lansky PS of ≥70 (if aged \\\u003C16 years).\n\n   Prior Therapy\n7. Any prior treatment-related toxicities resolved to ≤Grade 1 prior to enrollment, with the exception of ≤Grade 2 alopecia.\n8. Radiation Therapy: At least 60 days from prior total body irradiation, craniospinal radiation and\u002For ≥50% radiation of the pelvis, or at least 14 days from local palliative radiation therapy (small port).\n9. Stem Cell Infusion: At least 60 days must have elapsed from HSCT and at least 4 weeks (from first dose) must have elapsed from donor lymphocyte infusion without conditioning.\n10. Immunotherapy: At least 42 days since prior immunotherapy, including tumor vaccines and checkpoint inhibitors, and at least 21 days since receipt of chimeric antigen receptor therapy.\n11. Anti-Leukemia Therapy: At least 14 days since the completion of anti-leukemic therapy (for example, but not limited to, small molecule or cytotoxic\u002Fmyelosuppressive therapy), with the following exceptions:\n\n    * Hydroxyurea for cytoreduction can be initiated without restriction related to timing of study entry. Hydroxyurea for cytoreduction can be continued concomitantly with CBX-250, with Study Responsible Physician approval.\n    * Intrathecal chemotherapy at the time of diagnostic lumbar puncture at least 24 hours prior to the start of CBX-250 and may continue prophylactic intrathecal chemotherapy beginning in Cycle 2, at the treating physician's discretion.\n12. Hematopoietic Growth Factors: At least 7 days since the completion of therapy with short-acting hematopoietic growth factors and 14 days with long-acting growth factors.\n13. Biologics (e.g. monoclonal antibody therapy): At least 28 days or 5 half-lives, whichever is shorter, have elapsed since the completion of therapy with a biologic agent. Any AE related to prior biologic treatment must be resolved to baseline severity or ≤Grade 1.\n14. Steroids: At least 7 days since systemic glucocorticoid therapy, unless receiving physiologic dosing (equivalent to ≤10 mg prednisone daily) or cytoreductive therapy. Cytoreductive therapy must have approval of the Study Responsible Physician.\n\n    Adequate Organ Function Requirements within 10 Days of Treatment Initiation\n15. Estimated glomerular filtration rate ≥ 45 mL\u002Fmin\u002F1.73 m2 based on local institutional practice for age-appropriate determination (eg, Schwartz formula for pediatric participants or Cockcroft-Gault formula for adults).\n\n    1. Participants ≥18 years: glomerular filtration rate ≥45 mL\u002Fmin\n    2. Participants \\\u003C18 years: ≥45 mL\u002Fmin x (participant's body surface area m2\u002F1.73) • Adequate liver function defined as:\n\n       * Total bilirubin \\\u003C1.5 × the upper limit of normal (ULN) for age or normal conjugated bilirubin, or total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range in participants with well documented Gilbert's syndrome or hemolysis or who require regular blood transfusions.\n       * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C3 × ULN (unless attributed to leukemic involvement with discussion with the Study Responsible Physician).\n\n    Sex and Contraceptive\u002FBarrier Requirements\n16. If a female of childbearing potential, willing to use a highly effective method of contraception or double barrier method from the time of enrollment through 120 days following the last study drug dose.\n17. If male of childbearing potential, agrees to use barrier contraception from the time of enrollment through 120 days following the last study drug dose.\n\n    Informed Consent\n18. Participant or participant's health care proxy is able and willing to provide written informed consent and able to follow study instructions.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nDiagnosis\n\n1. Previous CTSG targeted therapy or treatment with any pMHC T-cell engager.\n2. Isolated extramedullary relapse.\n3. Active central nervous system (CNS) disease. Participants with prior CNS history can be enrolled if the participant has a negative lumbar puncture following completion of intrathecal chemotherapy).\n\n   Infection\n4. Known HIV infection.\n5. Active hepatitis B infection (participants with documented clearance following treatment are allowed).\n6. Active hepatitis C infection (participants with documented clearance following treatment are allowed).\n\n   Pregnancy and Breastfeeding\n7. Pregnant or nursing women: Negative serum pregnancy tests are required during Screening and a negative serum or urine pregnancy test is required within 72 hours prior to receiving the first study drug administration, in females of childbearing potential. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\n   Concurrent Conditions\n8. Cardiac Disease:\n\n   * Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled\u002Funstable angina, congestive heart failure (New York Heart Association Classification Class \\>II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack.\n   * QTc using Fridericia's correction (QTcF) \\>480 msec\n9. Graft-Versus-Host Disease (GVHD): Active acute or chronic GVHD requiring systemic treatment with immunosuppressive medication. Participants may be on physiological doses of steroids.\n10. Concurrent malignancy in the previous 2 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ, melanoma in situ) treated with potentially curative therapy. Concurrent malignancy must be in CR or no evidence of disease (NED) during this timeframe.\n11. History of or any concurrent condition, therapy, or laboratory abnormality that in the Investigator's opinion might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate.\n\n    Concomitant Medications and Interventions\n12. Any commercially available or investigational anti-leukemic therapy other than CBX-250, with the following exceptions:\n\n    • Intrathecal chemotherapy for CNS prophylaxis is permitted after C1 is complete, at the treating physician's discretion.\n13. Participation in another therapeutic interventional clinical study in which an investigational agent was administered within 14 days or 5-halflives, whichever is shorter, of starting CBX-250. Participants may continue with non-interventional follow-up from previous clinical studies.\n14. Any concurrent systemic treatment to prevent GVHD. Topical treatments for GVHD are permitted.\n15. Known allergy or sensitivity to study drug, including excipients.","12 Years",{"count":124,"type":20},72,[54],"Study CBX-250-001 is a Phase 1, open-label, dose-escalation study of CBX-250 in participants with relapsed\u002Frefractory AML, HR-MDS, CMML, and CML. Participants aged ≥ 12 years are planned to be enrolled. CBX-250 will initially be investigated on a fixed step-up dosing schedule. CBX-250 will be administered subcutaneously in 28-day cycles, with the first study drug dose administered on Cycle 1, Day 1. Cycle 1 will consist of a priming phase over 7 days, and a target phase over 28 days. Participants will continue CBX-250 until progressive disease (PD) or unacceptable toxicity. All subsequent treatment cycles will be 28 days.",[128,26,129,130],"High-risk Myelodysplastic Syndrome","AML - Acute Myeloid Leukemia","Chronic Myeloid Leukemia",[132,133,134,135,136,137,138,120,139,140],"AML","HR-MDS","CMML","acute leukemia","CBX-250","CBX-250-001","CROSSCHECK","Crossbow","CML","2026-03-12",{"date":103,"type":34},{"date":144,"type":34},"2025-07-16",{"date":146,"type":20},"2027-06",{"name":148,"class":149},"Crossbow Therapeutics, Inc.","INDUSTRY",11,{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":21,"phases":160,"briefSummary":161,"conditions":162,"keywords":172,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":5},"100589101","phase-1-a-phase-1-study-of-stx-0712-in-patients-with-advanced-hematological-malignancies-cmml-and-aml-100589101","NCT06950034","A Phase 1 Study of STX-0712 in Patients With Advanced Hematological Malignancies (CMML and AML)","A Phase 1, Open-Label, Dose Escalation and Expansion Study of STX-0712 in Patients With Advanced Hematologic Malignancies","Inclusion Criteria:\n\n* Refractory\u002Fresistant CMML, defined as: Diagnosis of CMML 1 or 2; and has not responded to at least 4 cycles of hypomethylating agents (HMAs)(for myeloproliferative CMML - HMAs or hydroxyurea) or discontinued prior to 4 cycles due to toxicity or has progressive disease OR\n* Relapsed\u002Frefractory monocytic or monocytic predominant AML. Monocytic predominant AML is defined as ≥50% monocytes and\u002For monocytic precursors (promonocytes\u002Fmonoblasts) and expressing at least two monocytic markers including CD4, CD11c, CD14, CD36, or CD64; and peripheral blood white blood cell (WBC) \\\u003C30,000\u002FµL (microliters) and \\\u003C20% circulating blasts.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.\n* Life expectancy of \\>2 months and stable enough to complete two cycles of STX-0712, in the opinion of the Investigator.\n* Adequate organ function.\n* Both females of child-bearing potential and males must agree to use acceptable contraceptive methods for the duration of time in the study and to continue to use acceptable contraceptive methods for 90 days after last STX-0712 infusion.\n* Able to understand and willing to sign a written informed consent form.\n* Willing and able to comply with study procedures and follow-up examinations.\n\nExclusion Criteria:\n\n* Has any of the following disease-specific conditions: For CMML: Myelodysplastic syndrome\u002Fmyeloproliferative neoplasm (MDS\u002FMPN) overlap syndromes other than CMML. For AML: Acute Promyelocytic Leukemia (APL) or Isolated extramedullary disease.\n* Eligible for an immediate allogenic stem cell transplant (alloSCT).\n* Current active use of nicotine products including tobacco, nicotine patches or vaping products.\n* Prior bone marrow transplant (BMT) within 6 months of date of consent; or transplanted patients who received the last dose of immunosuppressive therapies within 3 months of date of consent.\n* Has active autoimmune condition requiring immunosuppressive treatment or is receiving immunosuppressive therapy for the treatment of autoimmune disorders, allergies, or other clinical symptoms. Systemic steroids \\\u003C10 mg (milligrams) daily of prednisone equivalent are allowed; and intermittent use of bronchodilators or inhaled steroids, local steroid injections, topical steroids are allowed.\n* Received treatment with chemotherapy, biologic therapy, or wide-field radiation within 14 days of consent. Exceptions for hydroxyurea: For CMML and AML participants, hydroxyurea may be continued up to 72 hours prior to first dose of STX-0712. Hydroxyurea will also be permitted for first cycle of STX-0712 treatment for participants with proliferative CMML or AML with high white blood count (WBC ≥25,000\u002FµL).\n* Received an investigational treatment within 30 days prior to dosing with STX-0712.\n* Received Granulocyte Colony Stimulating Factor \\[G-CSF\\], Granulocyte Macrophage Colony Stimulating Factor \\[GM-CSF\\], erythropoietin, romiplostim, or other growth factors within 2 weeks prior to first dose of STX- 0712.\n* Received a live or live attenuated vaccine within 30 days before the first dose of STX-0712.\n* Clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association class 3 or 4 congestive heart failure, uncontrolled or unstable chest pain, history of heart attack(s), or stroke within 6 months prior to consent, uncontrolled high blood pressure, or clinically significant arrhythmias not controlled by medication).\n* QT interval corrected by Fridericia's formula (QTcF) \\>470 msec for both men and women on Screening electrocardiogram(s) (ECG). Patients with a bundle branch block must have QT interval corrected for bundle branch block.\n* Other than AML or CMML, active malignancy and\u002For cancer history that requires active therapy. Patients with the following neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ (including superficial bladder cancer), cervical intraepithelial neoplasia, or organ-confined prostate cancer with no evidence of progressive disease.\n* Active, uncontrolled bacterial, fungal, or viral infection.\n* Known human immunodeficiency virus (HIV).\n* Active or chronic hepatitis B or hepatitis C infection.\n* Evidence of any other severe or uncontrolled systemic diseases, any other serious and\u002For unstable pre-existing medical conditions, psychiatric disorder, or other conditions that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator.",{"count":159,"type":20},105,[54],"This is a first-in-human, multicenter, open-label, phase 1 study to evaluate the safety, PK, PD and preliminary efficacy of STX-0712 in patients with advanced CMML and AML for whom there are no further treatment options known to confer clinical benefit.",[163,26,164,165,166,134,167,59,168,169,170,171],"Chronic Myelomonocytic Leukemia","Chronic Myelomonocytic Leukemia-1","Chronic Myelomonocytic Leukemia-2","Refractory Chronic Myelomonocytic Leukemia","Acute Myeloid Leukemia","Acute Myeloid Leukemia Post Cytotoxic Therapy","Acute Myeloid Leukemias","Refractory Acute Myeloid Leukemia (AML)","Acute Monocytic Leukemia",[173,134,132,174,175,176,163,167,166,177],"refractory\u002Fresistant CMML","monocytic AML","Relapsed\u002Frefractory AML","monocytic-predominant AML","Refractory Acute Myeloid Leukemia","2026-02-05",{"date":180,"type":34},"2026-02-09",{"date":182,"type":34},"2025-03-13",{"date":184,"type":20},"2027-06-30",{"name":186,"class":149},"Solu Therapeutics, Inc",{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":21,"phases":195,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":202,"leadSponsor":204,"locationsCount":42},"100602812","phase-1-phase-iii-clinical-trial-of-axatilimab-a-csf1r-monoclonal-antibody-in-combination-with-ruxolitinib-as-therapy-for-patients-with-myelofibrosis-mf-and-chronic-myelomonocytic-leukemia-cmml-100602812","NCT07128381","Phase I\u002FII Clinical Trial of Axatilimab, a CSF1R Monoclonal Antibody, in Combination With Ruxolitinib as Therapy for Patients With Myelofibrosis (MF) and Chronic Myelomonocytic Leukemia (CMML)","Inclusion Criteria:\n\n* Age .18 years as MF and CMML are very rare diseases in the pediatric population.\n* Diagnosis of MF by WHO or ICC and:\n\n  1. Phase 1 dose escalation (Cohort A and B): at least 1 prior therapy for MF or with suboptimal response after at least 3 months of therapy with a JAK inhibitor.\n  2. Phase 2 dose expansion:\n\n  i. Relapsed cohort (Cohort C): Patients with at least 1 prior MF therapy. or ii. JAKi-naive cohort (Cohort D): patients with newly diagnosed and treatment naive MF with intermediate .1 risk by DIPSS-plus (Appendix 2)\n* Diagnosis of CMML refractory to treatment with hydroxyurea (for patients with proliferative CMML defined as WBC.13x109\u002FL) or at least 4 cycles of treatment with hypomethylating agent, with relapse\u002Fprogression after any number of cycles of hypomethylating agent therapy or who are intolerant of treatment with either therapy. Patients may have received prior therapy with other investigational agents or cytotoxic regimens.\n* ECOG performance status ≤2\n* Adequate hepatic function with total bilirubin \\\u003C\u002F=3 x ULN, AST or A LT \\\u003C\u002F= 3xULN unless related to disease involvement.\n* Serum creatinine clearance \\>30mL\u002Fmin and no end\u002Fstage renal disease (using Cockcroft-Gault).\n* Prior hydroxyurea for control of leukocytosis or use of hematopoietic growth factors (eg, G-CSF, GM-CSF, procrit, aranesp, thrombopoietin) is allowed at any time prior to cycle 1 day 1 of therapy.\n* Patient (or patient's legally authorized representative) must have signed an informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study. Non-English speaking patients may be consented.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\n  * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n  * Women of child-bearing potential 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. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n    * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n    * History of hysterectomy or bilateral salpingo-oophorectomy.\n    * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n    * History of bilateral tubal ligation or another surgical sterilization procedure.\n  * Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. 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  * Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients who are currently receiving treatment for a malignancy (not including basal cell carcinoma, nonmelanoma skin cancer, cervical carcinoma in situ, early stage breast cancer or localized prostate cancer treated with hormone therapy). Patients with history of other cancers should be free of disease for at least 2 years prior to the Screening Visit or not requiring active treatment at the time of enrollment.\n* Patients who are receiving any other investigational agents or with prior CSF1-R inhibitor therapy.\n* Active, uncontrolled bacterial, fungal, parasitic, or viral infection. Infections are considered controlled if appropriate therapy has been initiated and, at the time of screening, there is no evidence of infection worsening, such as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs, or radiographic findings attributable to infection.\n* Patients with evidence of active or latent tuberculosis. Prior to enrollment, patients should be evaluated for tuberculosis risk factors, and those at higher risk should be tested for latent infection. Risk factors include, but are not limited to, prior residence in or travel to countries with a high prevalence of tuberculosis, close contact with a person with active tuberculosis, and a history of active or latent tuberculosis where an adequate course of treatment cannot be confirmed.\n* Patients who have a known malabsorption syndrome or other condition that may impair absorption of study medication (e.g., gastrectomy).\n* History of acute or chronic pancreatitis.\n* Active symptomatic myositis.\n* Platelet count \\\u003C50x109\u002FL prior to enrollment and treatment initiation (for ruxolitinib combination cohorts only) except if related to either treatment for MF or CMML or treatment with cytotoxic therapy for any other reason.\n* Pregnant women are excluded from this study because axatilimab and ruxolitinib are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued if the mother is treated on study. These potential risks may also apply to other agents used in this study.\n* Patients with reproductive potential who are unwilling to following contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives \\[birth control pills\\], contraceptive injections, intrauterine devices \\[IUD\\], doublebarrier method \\[spermicidal jelly or foam with condoms or diaphragm\\], contraceptive patch, or surgical sterilization) throughout the study.\n* Female patients with reproductive potential who do not have a negative urine or blood betahuman chorionic gonadotropin (beta HCG) pregnancy test at screening.\n* Patients receiving any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy within 7 days of therapy initiation.\n* Patients with history of chronic hepatitis B or C, irrespective of surface antigen or viral load detection given risk of viral reactivation with JAK inhibitor therapy.\n* Patients with history of HIV given risk of JAK inhibitor-related immune-suppression.\n* New York Heart Association (NYHA) Class III or IV congestive heart failure or LVEF \\\u003C50 by echocardiogram or multigated acquisition (MUGA) scan.\n* History of myocardial infarction or thromboembolic disease within the last 6 months or unstable\u002Funcontrolled angina pectoris or history of severe and\u002For uncontrolled ventricular arrhythmias.\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.",{"count":194,"type":20},66,[54,87],"* To find the recommended dose of axatilimab given alone and in combination with ruxolitinib in patients with MF and CMML.\n* To learn if axatilimab given in combination with ruxolitinib can help to control MF and CMML.",[61,26],"2026-01-02",{"date":200,"type":34},"2026-01-05",{"date":198,"type":34},{"date":203,"type":20},"2033-07-31",{"name":205,"class":41},"M.D. Anderson Cancer Center",{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":215,"phases":4,"briefSummary":216,"conditions":217,"keywords":219,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":4},"100601687","the-kinetics-profiling-of-immune-reconstitution-and-clinical-outcomes-100601687","NCT07113730","The Kinetics Profiling of Immune Reconstitution and Clinical Outcomes","Retrospective and Prospective Study on the Kinetics Profiling of Immune Reconstitution and Clinical Outcomes in CMML Following Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. Patients with confirmed diagnosis of CMML following HSCT\n2. Patients treated at Peking University People's Hospital since January 1, 2005\n\nExclusion Criteria:\n\n1. Any condition that may render follow-up data unreliable, including but not limited to severe psychiatric disorders\n2. Patients deemed ineligible for the study by investigators",{"count":214,"type":20},300,"OBSERVATIONAL","Chronic myelomonocytic leukemia (CMML) is a clonal hematopoietic malignancy with poor prognosis. Allogeneic hematopoietic stem cell transplantation (HSCT) remains the only potentially curative treatment. Immune reconstitution (IR) is critical for improving HSCT efficacy and quality of life among survivors, yet its dynamic impact on survival and complications like chronic graft-versus-host disease (cGVHD) in CMML is poorly defined. This study aimed to investigate the dynamics of IR following HSCT in patients with CMML and evaluate its impact on post-transplant clinical outcomes.",[26,218],"Immune Reconstitution",[26,220,221],"immune reconstitution","allogeneic hematopoietic stem cell transplantation (allo-HSCT)","2025-08-11",{"date":224,"type":34},"2025-08-15",{"date":226,"type":20},"2025-08-13",{"date":228,"type":20},"2036-07-31",{"name":40,"class":41}]