Population PK-guided ATG Dosing in Haplo-HSCT

NCT07791576 | Recruiting Phase 2

• 1 other identifier: S2026-280-01
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• 1-year GVHD-free and relapse-free survival rate(1-year-GRFS)

  GRFS is defined as the time from randomization to the first occurrence of grade III-IV acute GVHD, chronic GVHD requiring systemic immunosuppressive therapy, or death due to disease relapse, whichever occurs first. The cumulative incidence of GRFS will be estimated using the Fine-Gray competing risk model.

  1 year after treatment

Secondary Outcomes (10)

• +180 days CMV virus reactivation rate

  180 days post-transplant

• Acute GVHD incidence

  100 days post-transplant

• disease free survival (DFS)

  1 years after treatment

• Cumulative incidence of relapse (CIR)

  1 years after treatment

• Cumulative non-relapse mortality (NRM)

  1 years after treatment

Study Arms (1)

Treatment

EXPERIMENTAL

PK-guided ATG dosing

Drug: Anti Thymocyte Globulin

Interventions

Anti Thymocyte Globulin DRUG

Population pharmacokinetic formula-guided targeted ATG dosing plus classical GVHD prophylaxis regimen

Treatment

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≤ 65 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.

You may not qualify if:

• No HLA-matched donor.
• Malignant hematologic disease in CR3 or higher disease stage, or refractory/relapsed status，or second transplantation.
• Patient age \< 14 years or \> 65 years.
• Pregnancy of either the donor or the recipient.
• Presence of mental illness or other conditions that preclude compliance with the protocol.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Interventions

Antilymphocyte Serum

Intervention Hierarchy (Ancestors)

Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures

Study Officials

• Dai-Hong Liu, director

  Chinese PLA General Hospital

  STUDY CHAIR

Central Study Contacts

Dai-Hong Liu, director

CONTACT

86-010-66937232; daihongrm@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 28, 2026
• Study Start: May 10, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)