RecruitingPhase 2NCT03779854

Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant

Multi-Center Phase II Randomized Controlled Trial of Naïve T Cell Depletion for Prevention of Chronic Graft-Versus-Host Disease in Children and Young Adults


Sponsor

Fred Hutchinson Cancer Center

Enrollment

68 participants

Start Date

Aug 29, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies how well naive T-cell depletion works in preventing chronic graft-versus-host disease in children and young adults with blood cancers undergoing donor stem cell transplant. Sometimes the transplanted white blood cells from a donor attack the body's normal tissues (called graft versus host disease). Removing a particular type of T cell (naive T cells) from the donor cells before the transplant may stop this from happening.


Eligibility

Min Age: 6 MonthsMax Age: 26 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new method of preparing stem cell transplants for children and young adults with blood cancers. The technique removes certain immune cells (called naive T cells) from the donor's stem cells before transplant, with the aim of reducing a serious complication called chronic graft-versus-host disease — where the donor's immune cells attack the patient's body. **You may be eligible if...** - You have a blood cancer such as acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), or myelodysplastic syndrome (MDS), in remission or with limited disease - You are a candidate for a stem cell transplant from a donor - You meet the age, health, and disease-specific criteria assessed by the study team **You may NOT be eligible if...** - Your leukemia is not in adequate remission - You have active, uncontrolled infection - You have severe organ problems that would make transplant too risky - You do not have a suitable donor identified 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

DRUGCyclophosphamide

Given IV

DRUGBusulfan

Given IV

PROCEDUREAllogeneic Bone Marrow Transplantation

Receive unmanipulated T cell replete BM

DRUGTacrolimus

Given IV

DRUGMethotrexate

Given IV

PROCEDURENaive T Cell-Depleted Hematopoietic Stem Cell Transplantation

Receive naive T-cell depleted PBSCs

PROCEDUREEchocardiography

Undergo ECHO

PROCEDUREBiospecimen Collection

Undergo CSF and blood sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy


Locations(10)

Children's Hospital of Los Angeles

Los Angeles, California, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Dana Farber / Boston Children's Hospital

Boston, Massachusetts, United States

UH Rainbow Babies and Children's Hospital (University Hospitals Cleveland Medical Center)

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

Children's Hospital of Pittsburgh of UPMC

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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NCT03779854


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