NCT03779854View on ClinicalTrials.gov

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

PHASE2RecruitingINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

August 29, 2019

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Acute Biphenotypic LeukemiaAcute LeukemiaAcute Leukemia of Ambiguous LineageAcute Lymphoblastic LeukemiaAcute Undifferentiated LeukemiaAllogeneic Hematopoietic Stem Cell Transplantation RecipientBlastic Plasmacytoid Dendritic Cell NeoplasmBlasts Under 25 Percent of Bone Marrow Nucleated CellsBlasts Under 5 Percent of Bone Marrow Nucleated CellsMixed Phenotype Acute LeukemiaMyelodysplastic Syndrome With Excess Blasts-1Myelodysplastic Syndrome/Acute Myeloid LeukemiaBurkitt LeukemiaChronic Monocytic LeukemiaLymphoblastic LymphomaMast Cell LeukemiaMyeloproliferative Neoplasm
Interventions
RADIATION

Total-Body Irradiation

Undergo TBI

DRUG

Thiotepa

Given IV

DRUG

Fludarabine

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Busulfan

Given IV

PROCEDURE

Allogeneic Bone Marrow Transplantation

Receive unmanipulated T cell replete BM

DRUG

Tacrolimus

Given IV

DRUG

Methotrexate

Given IV

PROCEDURE

Naive T Cell-Depleted Hematopoietic Stem Cell Transplantation

Receive naive T-cell depleted PBSCs

PROCEDURE

Echocardiography

Undergo ECHO

PROCEDURE

Biospecimen Collection

Undergo CSF and blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

Trial Locations (10)

15224

RECRUITING

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

30329

NOT_YET_RECRUITING

Children's Healthcare of Atlanta, Atlanta

44106

NOT_YET_RECRUITING

UH Rainbow Babies and Children's Hospital (University Hospitals Cleveland Medical Center), Cleveland

44195

RECRUITING

Cleveland Clinic Foundation, Cleveland

52242

RECRUITING

University of Iowa/Holden Comprehensive Cancer Center, Iowa City

90027

RECRUITING

Children's Hospital of Los Angeles, Los Angeles

97239

RECRUITING

Oregon Health and Science University, Portland

98109

RECRUITING

Fred Hutch/University of Washington Cancer Consortium, Seattle

200100

WITHDRAWN

Children's National Medical Center, Washington D.C.

02115

NOT_YET_RECRUITING

Dana Farber / Boston Children's Hospital, Boston

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Fred Hutchinson Cancer Center

OTHER