RecruitingPhase 2NCT03970096

Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)

A Phase II Randomized Controlled Trial Comparing GVHD-Reduction Strategies for Allogeneic Peripheral Blood Transplantation (PBSCT) for Patients With Acute Leukemia or Myelodysplastic Syndrome: Selective Depletion of CD45RA+ Naïve T Cells (TND) vs. Post-Transplantation Cyclophosphamide (PTCy)


Sponsor

Fred Hutchinson Cancer Center

Enrollment

120 participants

Start Date

Nov 19, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial investigates two strategies and how well they work for the reduction of graft versus host disease in patients with acute leukemia or MDS in remission. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.


Eligibility

Min Age: 1 YearMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing ways to reduce graft-versus-host disease (GVHD) — a serious complication where donor immune cells attack the patient's body — after a bone marrow or stem cell transplant. It is for adults with leukemia or myelodysplastic syndrome (MDS) who need a transplant from a donor. **You may be eligible if...** - You have acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), or another related blood cancer - Your disease is in remission (less than 5% cancer cells in the marrow) - You are a good candidate for a high-intensity transplant that uses total body irradiation - A matched donor is available **You may NOT be eligible if...** - Your disease is not in sufficient remission - You are not medically fit for intensive conditioning (preparation) before transplant - You do not have an eligible donor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONTotal-Body Irradiation

Undergo TBI

DRUGThiotepa

Given IV

DRUGFludarabine

Given IV

DRUGTacrolimus

Given IV

BIOLOGICALAllogeneic CD34+-enriched and CD45RA-depleted PBSCs

Given IV

DRUGMethotrexate

Given IV

DRUGCyclophosphamide

Given IV

BIOLOGICALPeripheral Blood Stem Cell

Given IV

DRUGCyclosporine

Given IV

DRUGSirolimus

Given IV

DRUGBusulfan

Given IV

PROCEDUREBone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration/biopsy

PROCEDUREEchocardiography

Undergo ECHO

PROCEDUREMultigated Acquisition Scan

Undergo MUGA

PROCEDUREBiospecimen Collection

Undergo blood sample collection


Locations(3)

Moffitt Cancer Center

Tampa, Florida, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT03970096


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