Thiotepa-Containing Conditioning Regimen for Allogeneic HSCT in Chronic Myelomonocytic Leukemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University People's Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
For haploidentical donor: at least 5/10 HLA match at HLA-A, -B, -C, -DQB1, and -DRB1.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- TBF regimen
Treatment groups
31 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov