Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 66
Summary
- Conditions
- Acute Undifferentiated Leukemia
- Acute Biphenotypic Leukemia
- Acute Leukemia
- Acute Leukemia of Ambiguous Lineage
- Acute Lymphoblastic Leukemia
- Allogeneic Hematopoietic Stem Cell Transplantation Recipient
- Blastic Plasmacytoid Dendritic Cell Neoplasm
- Myelodysplastic Syndrome With Excess Blasts-2
- Blasts Under 25 Percent of Bone Marrow Nucleated Cells
- Blasts Under 5 Percent of Bone Marrow Nucleated Cells
- Mixed Phenotype Acute Leukemia
- Myelodysplastic Syndrome With Excess Blasts-1
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 622 years
- Gender
- Both males and females
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 fludarabi...
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 over 30 minutes QD on days -6 to -2, busulfan IV over 180 minutes QD on days -5 to -2, and undergo total body irradiation BID on day -1. ARM I: Patients receive naive T-cell depleted PBSCs on day 0. ARM II: Patients receive unmanipulated T cell-replete BM on day 0. GVHD PROPHYLAXIS: All patients receive tacrolimus IV on days -1 to +50 followed by a taper in the absence of grade II-IV aGVHD. Patients also receive methotrexate IV on days +1, +3, +6, and +11. After completion of study treatment, patients are followed up periodically.
Tracking Information
- NCT #
- NCT03779854
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Marie Bleakley Fred Hutch/University of Washington Cancer Consortium