Thiotepa-based conditioning regimen before allogeneic stem cell transplant for CMML

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm study evaluating a thiotepa-containing conditioning regimen (TBF: thiotepa, busulfan, fludarabine, with or without ATG) prior to allogeneic HSCT in adults with CMML categorized as intermediate-2 or high risk. The primary goal is to assess relapse-free survival and overall survival at 1 year, with secondary goals including engraftment, transplant-related complications, and treatment-related toxicity. The study plans to enroll 31 participants, all undergoing transplant with a suitable donor. Eligibility requires confirmed CMML by 2022 WHO criteria, adequate organ function, controlled comorbidities, and an appropriately matched donor. The lead sponsor is Peking University People’s Hospital, with sites in Beijing, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University People's Hospital
  Beijing, China Recruiting

Study contacts

• Principal investigator: Yuqian Sun, MD — Peking University People's Hospital
• Study coordinator: Yuqian Sun, MD
• Email: sunyuqian83@hotmail.com
• Phone: +86 88326666

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.