NCT07791576 Population PK-guided ATG Dosing in Haplo-HSCT
| NCT ID | NCT07791576 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Chinese PLA General Hospital |
| Condition | Hematopoietic Stem Cell Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 63 participants |
| Start Date | 2025-05-10 |
| Primary Completion | 2026-12-30 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 63 participants in total. It began in 2025-05-10 with a primary completion date of 2026-12-30.
⚠ 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
To evaluate the safety and efficacy of a population pharmacokinetics (PK)-guided targeted ATG dosing strategy in haploidentical stem cell transplantation and to observe the GVHD-free, relapse-free survival (GRFS) in the cohort receiving this strategy.
Eligibility Criteria
Inclusion Criteria: 1. Patients with indications for allogeneic hematopoietic stem cell transplantation, with malignant hematologic diseases in CR1 or CR2 before transplantation. 2. Have an HLA-matched sibling, unrelated, or haploidentical donor. 3. Age ≥ 14 years and ≤ 65 years. 4. Liver function: ALT and AST ≤ 2.5 × upper limit of normal, bilirubin ≤ 2 × upper limit of normal. 5. Renal function: creatinine ≤ upper limit of normal. 6. No uncontrolled infection or severe mental or psychological disorders. 7. ECOG performance status score of 0-2. 8. Signed informed consent. Exclusion Criteria: 1. No HLA-matched donor. 2. Malignant hematologic disease in CR3 or higher disease stage, or refractory/relapsed status，or second transplantation. 3. Patient age \< 14 years or \> 65 years. 4. Pregnancy of either the donor or the recipient. 5. Presence of mental illness or other conditions that preclude compliance with the protocol.
Contact & Investigator
Dai-Hong Liu, director
STUDY CHAIR
Chinese PLA General Hospital
Frequently Asked Questions
Who can join the NCT07791576 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 65 Years, studying Hematopoietic Stem Cell Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07791576 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07791576 currently recruiting?
Yes, NCT07791576 is actively recruiting participants. Contact the research team at daihongrm@163.com for enrollment information.
Where is the NCT07791576 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07791576 clinical trial?
NCT07791576 is sponsored by Chinese PLA General Hospital. The principal investigator is Dai-Hong Liu, director at Chinese PLA General Hospital. The trial plans to enroll 63 participants.