drugset
drugset / Trial / NCT03128359

High Dose Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil in Preventing Graft Versus Host Disease in Patients With Hematological Malignancies Undergoing Myeloablative or Reduced Intensity Donor Stem Cell Transplant

NCT03128359 ↗

Phase 2 Completed 38 enrolled City of Hope Medical Center National Cancer Institute (NCI) · collab
Non-randomizedParallel-groupOpen-labelSupportive care

Summary

This pilot phase II trial studies how well high dose cyclophosphamide, tacrolimus, and mycophenolate mofetil work in preventing graft versus host disease in patients with hematological malignancies undergoing myeloablative or reduced intensity donor stem cell transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft versus host disease). Giving high dose cyclophosphamide, tacrolimus, and mycophenolate mofetil after the transplant may stop this from happening.

Timeline

Start
2017-05-30
Primary completion
2020-08-01
Completion
2021-09-15

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified — Intravenous
Background Busulfan Small molecule — Intravenous
Background Fludarabine Small molecule — Intravenous
Background Melphalan Small molecule — Intravenous
Background Mycophenolate Mofetil Small molecule — Intravenous
Background Tacrolimus Small molecule — Intravenous

Indications

Hodgkins lymphoma acute myeloid leukemia with multilineage dysplasia chronic lymphocytic leukemia/small lymphocytic lymphoma chronic myeloid leukemia diffuse large B-cell lymphoma follicular lymphoma graft versus host disease mantle cell lymphoma marginal zone lymphoma myelodysplastic syndrome plasma cell myeloma