NCT07588594 Thiotepa-Containing Conditioning Regimen for Allogeneic HSCT in Chronic Myelomonocytic Leukemia
| NCT ID | NCT07588594 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University People's Hospital |
| Condition | Chronic Myelomonocytic Leukemia (CMML) |
| Study Type | INTERVENTIONAL |
| Enrollment | 31 participants |
| Start Date | 2026-02-13 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 31 participants in total. It began in 2026-02-13 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Yuqian Sun, MD
PRINCIPAL INVESTIGATOR
Peking University People's Hospital
Frequently Asked Questions
Who can join the NCT07588594 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Myelomonocytic Leukemia (CMML). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07588594 currently recruiting?
Yes, NCT07588594 is actively recruiting participants. Contact the research team at sunyuqian83@hotmail.com for enrollment information.
Where is the NCT07588594 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07588594 clinical trial?
NCT07588594 is sponsored by Peking University People's Hospital. The principal investigator is Yuqian Sun, MD at Peking University People's Hospital. The trial plans to enroll 31 participants.
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