Actively Recruiting
Study of Thiotepa-Based Conditioning for Stem Cell Transplant in High-Risk 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
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
Research Team
Y
Yuqian Sun, MD
X
Xueyi Luo, MD
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