Population PK-guided ATG Dosing in Haplo-HSCT

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

In haplo-HSCT, ATG is commonly used to prevent GVHD but traditional dosing can lead to infection or relapse due to over-immunosuppression or under-immunosuppression. This phase 2 trial applies population pharmacokinetics to tailor ATG dosing for each patient, aiming to balance GVHD prevention with immune reconstitution. The study will monitor safety, engraftment, GVHD rates, infections, relapse, and GVHD-free, relapse-free survival (GRFS) in participants aged 14–65 with malignant hematologic diseases. Eligible donors include haploidentical, matched related, or matched unrelated. Enrollment is at Chinese PLA General Hospital in Beijing.

Why it matters

Who can join: the full rules

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.

Where it's running

• Chinese PLA General Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Dai-Hong Liu, director
• Email: daihongrm@163.com
• Phone: 86-010-66937232

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.