Population PK-guided ATG Dosing in Haplo-HSCT
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14-65
SponsorChinese PLA General Hospital
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 volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Anti Thymocyte Globulin
DrugPopulation pharmacokinetic formula-guided targeted ATG dosing plus classical GVHD prophylaxis regimen
Treatment groups
63 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 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 year after treatmentSecondary 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-transplant2
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-transplant3
disease free survival (DFS)
Disease free survival (DFS) refers to the time from treatment to the first lymphoma recurrence.
Time frame
1 years after treatment4
Cumulative incidence of relapse (CIR)
Cumulative incidence of relapse (CIR) refers to the number of patients with hematologic or MRD relapse from randomization to the last follow-up.
Time frame
1 years after treatmentSponsors and contacts
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Source ClinicalTrials.gov