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Clinical Trial 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.


Clinical Trial 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 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. ;


Study Design


Related Conditions & MeSH terms

  • Acute Biphenotypic Leukemia
  • Acute Disease
  • Acute Leukemia
  • Acute Leukemia of Ambiguous Lineage
  • Acute Lymphoblastic Leukemia
  • Acute Undifferentiated Leukemia
  • Allogeneic Hematopoietic Stem Cell Transplantation Recipient
  • Anemia, Refractory, with Excess of Blasts
  • Blastic Plasmacytoid Dendritic Cell Neoplasm
  • Blasts Under 25 Percent of Bone Marrow Nucleated Cells
  • Blasts Under 5 Percent of Bone Marrow Nucleated Cells
  • Bronchiolitis Obliterans Syndrome
  • Graft vs Host Disease
  • Leukemia
  • Leukemia, Biphenotypic, Acute
  • Mixed Phenotype Acute Leukemia
  • Myelodysplastic Syndrome With Excess Blasts-1
  • Myelodysplastic Syndromes
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Preleukemia
  • Syndrome

NCT number NCT03779854
Study type Interventional
Source Fred Hutchinson Cancer Center
Contact Marie Bleakley
Phone 206-667-6572
Email mbleakle@fredhutch.org
Status Recruiting
Phase Phase 2
Start date August 29, 2019
Completion date December 31, 2025

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