Actively Recruiting
Prospective Single-Arm Clinical Study of Thiotepa-Containing Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation in Chronic Myelomonocytic Leukemia
Led by Peking University People's Hospital · Updated on 2026-05-26
31
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a conditioning treatment that includes thiotepa, combined with busulfan and fludarabine, with or without ATG, for patients with chronic myelomonocytic leukemia (CMML) who have an intermediate-2 or high-risk prognosis. This prospective, single-arm clinical study aims to assess the safety and effectiveness of this regimen in the context of allogeneic hematopoietic stem cell transplantation (allo-HSCT). Participants will receive the TBF regimen: intravenous thiotepa on days -11 and -10, busulfan on days -8 to -6, fludarabine on days -6 to -2, and ATG depending on donor type from days -5 to -2. Allogeneic stem cells will be infused on day 0, followed by graft-versus-host disease (GVHD) prevention using medications such as CsA, MMF, and MTX as per the protocol. During the study, researchers will monitor outcomes including one-year relapse-free survival, overall survival, transplant-related complications, and side effects. They will also assess engraftment, incidence and severity of acute and chronic GVHD, regimen toxicity at day 30, and mortality. The study plans to enroll 31 participants and will continue until May 2028.
CONDITIONS
Brief Title
Thiotepa-Containing Conditioning Regimen for Allogeneic HSCT in Chronic Myelomonocytic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any sex or gender
- Confirmed diagnosis of chronic myelomonocytic leukemia (CMML) according to 2022 WHO classification
- Intermediate-2 or high-risk CMML by CPSS or CPSS-mol score
- Planned to receive allogeneic hematopoietic stem cell transplantation (allo-HSCT)
- Suitable hematopoietic stem cell donor with required HLA match: haploidentical (at least 5/10), unrelated (at least 9/10), or matched sibling donor (10/10)
- Hematopoietic cell transplantation comorbidity index (HCT-CI) of 2 or less with good health and no major organ problems
- Adequate organ function including LVEF ≥ 50%, bilirubin ≤ 1.5×ULN, ALT and AST ≤ 2×ULN, serum creatinine ≤ 1.5×ULN
- Baseline oxygen saturation over 92%
- Pulmonary function: DLCO ≥ 40%, FEV1 ≥ 50%
- ECOG performance status 0 to 2
- Agrees not to participate in other interventional studies during treatment
- Willing and able to provide informed consent and comply with study requirements
You will not qualify if you...
- Previous allogeneic hematopoietic stem cell transplantation for CMML that later relapsed
- Unwilling or unable to receive the study treatment regimen
- Active hepatitis B or C, chronic active hepatitis, or known HIV infection
- Active uncontrolled infection with hemodynamic instability, new infection lesions, or unexplained persistent fever
- History of stroke or intracranial hemorrhage within 6 months before enrollment
- Known pregnancy or currently breastfeeding
- Diagnosis of another malignancy within past 2 years except certain treated localized cancers
- Any condition judged by the investigator to make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks including conditioning and transplantation day
Participants receive a thiotepa-containing conditioning regimen followed by allogeneic hematopoietic stem cell transplantation.
Daily visits during conditioning and transplantation period
Duration - Up to 12 months after transplantation
Participants are monitored for transplant outcomes, adverse events, and graft-versus-host disease up to one year after transplantation.
Regular visits up to 1 year post-transplant
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, China, 100044
Actively Recruiting
Research Team
Y
Yuqian Sun, MD
X
Xueyi Luo, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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