Health Trials

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

ConditionsAcute 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
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6-26
SponsorFred Hutchinson Cancer Center

About this trial

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

Qualifiers

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)

Disqualifiers

Active central nervous system (CNS) disease. A patient may have a history of CNS disease; however, any CNS disease must be cleared by the end of the pre-conditioning evaluation. If CNS disease is identified on the first cerebrospinal fluid (CSF) evaluation within 30 days of the start of the preparative regimen, a repeat CSF evaluation must be performed and show no evidence of disease in order for the patient to be eligible for the protocol.

Patients on other experimental protocols for the prevention of GVHD.

Matched related donor (MRD): > 100 kg are ineligible

Matched unrelated donor (MUD): > 75 kg must be discussed with the protocol principal investigator (PI) prior to enrollment.

Trial design

Treatments tested in this trial

  • Total-Body Irradiation
  • Thiotepa
  • Fludarabine
  • Cyclophosphamide
  • Busulfan
  • Allogeneic Bone Marrow Transplantation
  • Tacrolimus
  • Methotrexate
  • Naive T Cell-Depleted Hematopoietic Stem Cell Transplantation
  • Echocardiography
  • Biospecimen Collection
  • Bone Marrow Aspiration
  • Bone Marrow Biopsy

Treatment groups

68 Participants
are divided into 2 treatment groups

Locations

10
California
Children's Hospital of Los Angeles90027, Los Angeles United States
District of Columbia
Children's National Medical Center200100, Washington D.C. United States
Georgia
Children's Healthcare of Atlanta30329, Atlanta United States
Iowa
University of Iowa/Holden Comprehensive Cancer Center52242, Iowa City United States

Sponsors and collaborators

Fred Hutchinson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov