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RECRUITING Not applicable ClinicalTrials.gov

Thiotepa-Containing Conditioning Regimen for Allogeneic HSCT in Chronic Myelomonocytic Leukemia

Sponsor: Peking University People's Hospital • ClinicalTrials.gov ID: NCT07588594

Registry updated: 2026-09-15
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Description

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. The 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.

Interventions

  • TBF regimen (Drug)
    Intravenous thiotepa 5 mg/kg/d on days -11,-10; busulfan 3.2 mg/kg/d on days -8,-7,-6; fludarabine 30 mg/m²/d on days -6 to -2; ATG per donor type (haplo/unrelated: 2.5 mg/kg/d days -5 to -2; MSD: 1.125 mg/kg/d days -5 to -2). Allogeneic stem cells infused on day 0. GVHD prophylaxis: CsA, MMF, MTX per protocol.

Eligibility criteria

Inclusion Criteria: * Age ≥ 18 years, any sex/gender. * Confirmed diagnosis of chronic myelomonocytic leukemia (CMML) according to the 2022 WHO classification. * Intermediate-2 or high-risk CMML based on CPSS or CPSS-mol score, and planned to receive allo-HSCT. * Has a suitable hematopoietic stem cell donor: * For haploidentical donor: at least 5/10 HLA match at HLA-A, -B, -C, -DQB1, and -DRB1. * For unrelated donor: at least 9/10 HLA match at the same five loci. * For matched sibling donor: 10/10 HLA match at the same five loci. * Hematopoietic cell transplantation comorbidity index (HCT-CI) ≤ 2, with generally good health and no significant organ abnormalities or major comorbidities. * Adequate organ function as defined below: * Left ventricular ejection fraction (LVEF) ≥ 50%, and no uncontrolled tachycardia or bradycardia-tachycardia syndrome. * Total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT ≤ 2 × ULN; AST ≤ 2 × ULN. * Serum creatinine ≤ 1.5 × ULN. * Baseline oxygen saturation \> 92%. * Pulmonary function: DLCO (corrected for hemoglobin) ≥ 40%, FEV1 ≥ 50%. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. * Agrees not to participate in any other interventional study during the treatment period. * Willing and able to provide written informed consent, understand the nature, purpose, and procedures of the study, and voluntarily comply with study requirements. Exclusion Criteria: * Previous allogeneic HSCT for CMML that later relapsed. * Unwilling or unable to receive the study treatment regimen. * Active hepatitis B or C, or chronic active hepatitis; known human immunodeficiency virus (HIV) infection. * Active uncontrolled infection, including: hemodynamic instability related to infection, new or worsening signs/symptoms of infection, new infection lesions on imaging, or persistent fever without explanation despite no symptoms/signs. * History of stroke or intracranial hemorrhage within 6 months before enrollment. * Known pregnancy (positive urine pregnancy test), or currently breastfeeding. * 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. * Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.

Conditions

Chronic Myelomonocytic Leukemia (CMML)

Locations

  • Peking University People's Hospital — Beijing, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record