Personalized ATG dosing in unrelated donor stem cell transplants

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

The study compares individualized ATG dosing to conventional fixed-dose ATG regimens in patients undergoing unrelated donor peripheral blood stem cell transplantation for malignant hematologic diseases. It aims to see if personalized dosing can reduce complications and improve outcomes by optimizing immune suppression and graft-versus-host disease prevention. The trial is conducted in a setting with high CMV challenge, with the goal of improving overall survival and long-term prognosis. This is a Phase 4 interventional study led by Daihong Liu, with collaboration from Peking University People’s Hospital and The First Affiliated Hospital of Zhengzhou University, 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.

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, Dr.
• Email: daihongrm@163.com
• Phone: 86-010-66937232

Similar studies

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

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• Etamsylate versus placebo to prevent bleeding after stem cell transplant

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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.