NCT02220985View on ClinicalTrials.gov

Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts From HLA-Matched Related and Unrelated Donors in Preventing GVHD

PHASE2CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

February 3, 2015

Primary Completion Date

April 1, 2025

Study Completion Date

May 1, 2025

Conditions
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveAcute Biphenotypic LeukemiaAcute Leukemia of Ambiguous LineageAcute Undifferentiated LeukemiaAllogeneic Hematopoietic Stem Cell Transplant RecipientBlast Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveBlastic Plasmacytoid Dendritic Cell NeoplasmChildhood Acute Lymphoblastic Leukemia in RemissionChildhood Acute Myeloid Leukemia in RemissionDonorLymphoblastic LymphomaMyelodysplastic Syndrome With Excess BlastsMyelodysplastic Syndrome With Excess Blasts-1Myelodysplastic Syndrome With Excess Blasts-2Recurrent Acute Lymphoblastic LeukemiaRecurrent Acute Myeloid LeukemiaRecurrent Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Acute Myeloid LeukemiaRecurrent Chronic Myelogenous Leukemia, BCR-ABL1 PositiveRefractory Acute Lymphoblastic LeukemiaRefractory Acute Myeloid LeukemiaAcute Lymphoblastic Leukemia in RemissionAcute Myeloid Leukemia in Remission
Interventions
PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic HSCT

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine Phosphate

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Methotrexate

Given IV

DRUG

Mycophenolate Mofetil

Given IV and PO

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo PBSCT with GCSF-mobilized CD34-enriched PBSC

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo PBSCT with CD45RA-depleted cells

DRUG

Tacrolimus

Given IV or PO

DRUG

Thiotepa

Given IV

RADIATION

Total-Body Irradiation

Undergo TBI

Trial Locations (2)

15232

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh

98109

Fred Hutch/University of Washington Cancer Consortium, Seattle

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Fred Hutchinson Cancer Center

OTHER

NCT02220985 - Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts From HLA-Matched Related and Unrelated Donors in Preventing GVHD | Biotech Hunter | Biotech Hunter