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

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
• Burkitt Leukemia
• Chronic Monocytic Leukemia
• Lymphoblastic Lymphoma
• Mast Cell Leukemia
• Mixed Phenotype Acute Leukemia
• Myelodysplastic Syndrome With Excess Blasts-1
• Myelodysplastic Syndrome/Acute Myeloid Leukemia
• Myeloproliferative Neoplasm

Eligibility Criteria

Sex

ALL

Age

6 Months - 26 Years

Healthy Volunteers

Accepted

Interventions

• Total-Body Irradiation — RADIATION
  Undergo TBI
• Thiotepa — DRUG
  Given IV
• Fludarabine — DRUG
  Given IV
• Cyclophosphamide — DRUG
  Given IV
• Busulfan — DRUG
  Given IV
• Allogeneic Bone Marrow Transplantation — PROCEDURE
  Receive unmanipulated T cell replete BM
• Tacrolimus — DRUG
  Given IV
• Methotrexate — DRUG
  Given IV
• Naive T Cell-Depleted Hematopoietic Stem Cell Transplantation — PROCEDURE
  Receive naive T-cell depleted PBSCs
• Echocardiography — PROCEDURE
  Undergo ECHO
• Biospecimen Collection — PROCEDURE
  Undergo CSF and blood sample collection
• Bone Marrow Aspiration — PROCEDURE
  Undergo bone marrow aspiration
• Bone Marrow Biopsy — PROCEDURE
  Undergo bone marrow biopsy

Study Details

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.

Key Dates

Start date

Aug 29, 2019

Status verified

May 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

68 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (chemotherapy, naive T-cell depleted PBSC)
  CONDITIONING REGIMEN A: Patients undergo TBI BID on days -10 to -7, then receive thiotepa IV over 3 hours 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. TRANSPLANT: Patients receive naive T-cell depleted PBSCs on day 0. GVHD PROPHYLAXIS: All patients receive tacrolimus IV beginning on day -1 and methotrexate IV on days 1, 3, 6, and 11. Additionally, patients undergo ECHO and CSF collection at baseline as well as blood sample collection and bone marrow aspiration with or without biopsy throughout the trial.
• Active Comparator: Arm II (chemotherapy, unmanipulated T cell replete BM)
  CONDITIONING REGIMEN A: Patients undergo TBI BID on days -10 to -7, then receive thiotepa IV over 3 hours 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. TRANSPLANT: Patients receive unmanipulated T cell-replete BM on day 0. GVHD PROPHYLAXIS: All patients receive tacrolimus IV beginning on day -1 and methotrexate IV on days 1, 3, 6, and 11. Additionally, patients undergo ECHO and CSF collection at baseline as well as blood sample collection and bone marrow aspiration with or without biopsy throughout the trial.

Primary Outcome Measure

Feasibility achievement [ Time Frame: Up to 2 years ]

Central Contacts

• Marie Bleakley
  206-667-6572
  [email protected]

Locations (10)

Find similar trials in Los Angeles, CA

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