drugset / Trial / NCT03456817

HIgh Dose Thymoglobulin Instead of Cyclosporine With a Low Dose of Thymoglobulin for GVHD Prophylaxis

NCT03456817 ↗

Phase 2 Terminated 68 enrolled AHS Cancer Control Alberta
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to find out whether compared to our standard low dose ATG with CSA, the high dose ATG with low-dose CSA minimizes the chances of relapse and chronic GVHD, without increasing the chances of other transplant complications.

Timeline

Start
2020-07-01
Primary completion
2025-05-31
Completion
2025-05-31

Outcome

Outcome not reported

Stopped (Enrollment): “Slow patient accrual and appearance of a toxicity”

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclosporine Peptide 2.5 mg/kg Intravenous
Subject thymoglobulin Unknown 2 mg/kg Intravenous
Background Acetaminophen Small molecule — —
Background Busulfan Small molecule — —
Background Diphenhydramine Small molecule — —
Background Fludarabine Small molecule — —
Background Ibuprofen Small molecule — —
Background Meperidine Unknown 25 mg Intravenous
Background Meperidine Unknown 50 mg Intravenous
Background Methylprednisolone Other / unclassified — —
Background Treatment Arm - high dose ATG Unknown 10 mg/m2 Intravenous