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TERMINATED
NCT03246906
PHASE2

Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Blood Cell Transplantation

Sponsor: Fred Hutchinson Cancer Center

View on ClinicalTrials.gov

Summary

This randomized phase II trial includes a blood stem cell transplant from an unrelated donor to treat blood cancer. The treatment also includes chemotherapy drugs, but in lower doses than conventional (standard) stem cell transplants. The researchers will compare two different drug combinations used to reduce the risk of a common but serious complication called "graft versus host disease" (GVHD) following the transplant. Two drugs, cyclosporine (CSP) and sirolimus (SIR), will be combined with either mycophenolate mofetil (MMF) or post-transplant cyclophosphamide (PTCy). This part of the transplant procedure is the main research focus of the study.

Official title: A Randomized Phase II Study to Compare the Net Clinical Benefit of Cyclosporine and Sirolimus Combined With MMF or Post-Transplant Cyclophosphamide as GVHD Prophylaxis After HLA-Matched or HLA-Mismatched Unrelated G-CSF Mobilized Blood Cell Transplantation Using Nonmyeloablative or Reduced Intensity Conditioning for Patients With Hematologic Malignancies

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2017-09-11

Completion Date

2025-05-03

Last Updated

2026-05-14

Healthy Volunteers

No

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo HCT

DRUG

Cyclophosphamide

Given IV

DRUG

Cyclosporine

Given PO

DRUG

Mycophenolate Mofetil

Given PO

DRUG

Sirolimus

Given PO

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States