Population PK-guided ATG Dosing in Haploidentical Stem Cell Transplant

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 Phase 3 interventional study uses population pharmacokinetics to guide anti-thymocyte globulin dosing in haploidentical HSCT. The aim is to improve safety and efficacy by tailoring ATG to individual patient characteristics and observe GVHD-free, relapse-free survival in the treated cohort. The trial focuses on patients with malignant hematologic diseases who have a haploidentical or related donor and meet standard transplant eligibility criteria. Primary considerations include GVHD prevention, transplant-related morbidity, and overall long-term survival. Conducted at the Chinese PLA General Hospital in Beijing, it seeks to advance GVHD prevention strategies to potentially improve quality of life after transplant.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with indications for allogeneic hematopoietic stem cell transplantation, with malignant hematologic diseases in CR1 or CR2 before transplantation.
* Have an HLA-matched sibling, unrelated, or haploidentical donor.
* Age ≥ 14 years and ≤ 75 years.
* Liver function: ALT and AST ≤ 2.5 × upper limit of normal, bilirubin ≤ 2 × upper limit of normal.
* Renal function: creatinine ≤ upper limit of normal.
* No uncontrolled infection or severe mental or psychological disorders.
* ECOG performance status score of 0-2.
* Signed informed consent.

Exclusion Criteria:

* No HLA-matched donor.
* Malignant hematologic disease in CR3 or higher disease stage, or refractory/relapsed status.
* Patient age \< 14 years or \> 75 years.
* Pregnancy of either the donor or the recipient.
* 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

Similar studies

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

• Population PK-guided ATG Dosing in Haplo-HSCT

  This study tests a population PK-guided dosing strategy for anti-thymocyte globulin (ATG) in adults and adolescents undergoing haploidentical stem cell transplantation to see if it can reduce GVHD while keeping relapse risk acceptable.

  Recruiting Phase 2 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07791576

• Low-dose liposomal amphotericin B to prevent invasive fungal infections in neutropenic children

  This study tests whether giving a fixed low dose of liposomal amphotericin B can prevent invasive fungal infections in children aged 3–17 who are severely neutropenic after hematopoietic stem cell transplantation or similar high-risk conditions.

  Recruiting Haikou Affiliated Hospital of Central South University Xiangya School of Medicine · Haikou, Hainan · NCT07725263

• Personalized ATG dosing in unrelated donor stem cell transplants

  This trial tests whether tailoring anti-thymocyte globulin dosing works better than standard fixed dosing in adults and adolescents receiving unrelated donor stem cell transplants.

  Recruiting Phase 4 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07648992

• Hematologic cancer survivors after stem cell transplant try a personalized care plan

  This study tests a personalized Survivorship Care Plan for people with hematologic cancer who have undergone a stem cell transplant to see if it’s feasible within the Italian health system.

  Recruiting Azienda USL Reggio Emilia - IRCCS · Reggio Emilia · NCT07579065

• T-cell–guided letermovir stopping after allogeneic stem cell transplant

  This tests whether using a CMV-specific T-cell blood test to decide when adult CMV-positive patients can stop letermovir after allogeneic stem cell transplant keeps them protected while avoiding unnecessary drug exposure.

  Recruiting Phase 4 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Beijing, Beijing Municipality and 11 other locations · NCT07569653

• Etamsylate versus placebo to prevent bleeding after stem cell transplant

  This will test whether etamsylate can reduce bleeding in adults with very low platelets after hematopoietic stem cell transplantation.

  Recruiting Phase 3 First Affiliated Hospital of Zhejiang University · Hangzhou, Zhejiang · NCT07442513

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.