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

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.

Conditions

• Acute Biphenotypic Leukemia
• Acute Leukemia
• Acute Leukemia of Ambiguous Lineage
• Acute Lymphoblastic Leukemia
• Acute Undifferentiated Leukemia
• Allogeneic Hematopoietic Stem Cell Transplantation Recipient
• Blastic Plasmacytoid Dendritic Cell Neoplasm
• Blasts Under 25 Percent of Bone Marrow Nucleated Cells
• Blasts Under 5 Percent of Bone Marrow Nucleated Cells
• Mixed Phenotype Acute Leukemia
• Myelodysplastic Syndrome With Excess Blasts-1
• Myelodysplastic Syndrome/Acute Myeloid Leukemia
• Burkitt Leukemia
• Chronic Monocytic Leukemia
• Lymphoblastic Lymphoma
• Mast Cell Leukemia
• Myeloproliferative 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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Marie Bleakley · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

26 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-08-29

Primary Completion

2028-12-31

Completion

2028-12-31

FDA Drug

Yes

Countries

• United States

Study Locations