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RCT of Population PK-guided ATG Dosing in Haplo-HSCT

ConditionHematopoietic Stem Cell Transplantation
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age14-75
SponsorDaihong Liu

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

1.Patients with indications for allogeneic hematopoietic stem cell transplantation, with malignant hematologic diseases in CR1 or CR2 before transplantation.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anti-Thymocyte Globulin (ATG)

    Biological/Vaccine

    ATG (Thymoglobulin) IV, total dose 6-10 mg/kg (PK-guided, targeting AUC 100-148.5 IU·day/mL) for experimental arm; fixed 10 mg/kg for control arm, both given over Days -5 to -3 pre-transplant, combined with standard GVHD prophylaxis.

Treatment groups

324 Participants
are divided into 2 treatment groups
Group A: The experimental groupExperimental treatment 1 intervention
Group B: The control groupActive comparator 1 intervention

Trial outcomes

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.

Time frame
1 years after treatment

Secondary outcomes

1

+180 days CMV virus reactivation rate

+180 days CMV virus reactivation rate refers to the time from randomization to CMV virus reactivation, relapse or death within 180 days post-transplant. The actual incidence rate is calculated as the number of patients with events / total number of cases × 100%.

Time frame
180 days post-transplant
2

+180 days EBV virus reactivation rate

The +180-day EBV virus reactivation rate refers to the time from randomization to EBV virus reactivation, relapse, or death within 180 days post-transplant. The actual incidence rate is calculated as the number of patients with events / total number of cases × 100%.

Time frame
180 days post-transplant
3

Acute GVHD incidence

Acute GVHD incidence refers to the time from randomization to acute GVHD onset, relapse or death within 100 days post-transplant. The actual incidence rate is calculated as the number of patients with events / total number of cases × 100%.

Time frame
100 days post-transplant
4

disease free survival (DFS)

Disease free survival (DFS) refers to the time from treatment to the first lymphoma recurrence.

Time frame
2 years after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daihong Liu

Lead sponsor

Chinese PLA General Hospital

Sponsor institution

Source ClinicalTrials.gov
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