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Recruiting Phase 2 NCT03779854

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

Trial Parameters

Condition Acute Biphenotypic Leukemia
Sponsor Fred Hutchinson Cancer Center
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 68
Sex ALL
Min Age 6 Months
Max Age 26 Years
Start Date 2019-08-29
Completion 2027-12-31
Interventions
Total-Body IrradiationThiotepaFludarabine

Brief 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 Criteria

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 \[AUL\], lymphoblastic lymphoma, Burkitt leukemia/lymphoma, mast cell leukemia, chronic monocytic leukemia \[CML\] with blast crisis or other chronic myeloproliferative neoplasm) with \< 5% marrow blasts. * Myelodysplastic syndrome (MDS) with excess blasts (EB-1 and EB-2) and has received cytotoxic induction chemotherapy (excluding small molecule inhibitors and de-methylating agents) * Age 6 months to 26 years at

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