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

Acute Lymphoblastic Leukemia Clinical Trial

Official title: 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

Status Recruiting

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. ;

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