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
Fred Hutchinson Cancer Center
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.
Description
Patients are randomized to 1 of 2 arms. All patients receive 1 of 3 conditioning regimens. CONDITIONING REGIMEN A: Patients undergo total body irradiation (TBI) twice daily (BID) on days -10 to -7, then receive thiotepa intravenously (IV) over 3 hours once daily (QD) on days -6 and -5, and fludarabine IV over 30 minutes once daily on days -6 to -2. CONDITIONING REGIMEN B: Patients undergo TBI BID on days -8 to -5, then receive fludarabine IV over 30 minutes QD on days -4 to -2, and cyclophosphamide IV over 1 hour QD on days -3 and -2. CONDITIONING REGIMEN C: Patients receive fludarabine IV…
Eligibility
- Age range
- 0–26 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * The patient must have one of the following diagnoses and be considered to be an appropriate candidate for allogeneic HCT by the study site principal investigator (PI): * Acute lymphoblastic leukemia (ALL) with \< 5% marrow blasts. * Acute myeloid leukemia (AML) with \< 25% marrow blasts. * Other acute leukemia (OAL) or related neoplasm (including but not limited to acute biphenotypic leukemia \[ABL\], ambiguous lineage \[ALAL\], mixed phenotype acute leukemia \[MPAL\], blastic plasmacytoid dendritic cell neoplasm \[BPDCN\], acute undifferentiated leukemia \[AUL\],…
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
Locations (10)
- Children's Hospital of Los AngelesLos Angeles, California
- Children's National Medical CenterWashington D.C., District of Columbia
- Children's Healthcare of AtlantaAtlanta, Georgia
- University of Iowa/Holden Comprehensive Cancer CenterIowa City, Iowa
- Dana Farber / Boston Children's HospitalBoston, Massachusetts
- UH Rainbow Babies and Children's Hospital (University Hospitals Cleveland Medical Center)Cleveland, Ohio