drugset
drugset / Trial / NCT02661035

Allo HSCT Using RIC for Hematological Diseases

NCT02661035 ↗

Phase 2 Completed 156 enrolled Masonic Cancer Center, University of Minnesota
NaSingle-groupOpen-labelTreatment

Summary

This is a phase II trial using a non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen followed by a related or unrelated donor stem cell infusion. The primary objective is to evaluate rates of acute graft-versus-host disease (GVHD) grades II-IV and chronic GVHD with an updated GVHD prophylaxis of tacrolimus and mycophenolate mofetil (MMF) with a non-myeloablative preparative regimen in persons with hematologic malignancies.

Timeline

Start
2017-03-09
Primary completion
2023-04-17
Completion
2023-05-29

Drugs

EvaluationDrugModalityDoseRoute
Subject MMF Unknown 15 mg/kg Intravenous
Subject MMF Unknown 3 g Intravenous
Subject Peripheral blood stem cells Cell therapy — —
Subject Related or Unrelated Bone Marrow Cells Cell therapy 3e+08 cells/kg —
Subject Tacrolimus Small molecule 0.03 mg/kg Intravenous
Subject Tacrolimus Small molecule 0.05 mg/kg Intravenous
Background ATG Unknown — Intravenous
Background Allopurinol Small molecule 150 mg/m2 —
Background Allopurinol Small molecule 300 mg —
Background Cyclophosphamide Other / unclassified 50 mg/kg Intravenous
Background Fludarabine Small molecule 30 mg/m2 Intravenous

Indications

Burkitt lymphoma acute myeloid leukemia chronic lymphocytic leukemia/small lymphocytic lymphoma chronic myeloid leukemia follicular lymphoma lymphoblastic lymphoma lymphoplasmacytic lymphoma mantle cell lymphoma myelodysplastic syndrome plasma cell leukemia plasma cell myeloma prolymphocytic leukemia