Health Trials

Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases

ConditionsAcute Leukemia of Ambiguous LineageAcute Lymphoblastic LeukemiaAcute Myeloid LeukemiaBlastic Plasmacytoid Dendritic Cell NeoplasmHematopoietic and Lymphatic System NeoplasmMixed Phenotype Acute LeukemiaMyelodysplastic SyndromeMyeloproliferative NeoplasmNon-Hodgkin LymphomaChronic Myeloid Leukemia, BCR-ABL1 Positive
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6-65
SponsorFred Hutchinson Cancer Center

About this trial

This phase II trial studies how well giving an umbilical cord blood transplant together with cyclophosphamide, fludarabine, and total-body irradiation (TBI) works in treating patients with hematologic diseases. Giving chemotherapy, such as cyclophosphamide, fludarabine and thiotepa, and TBI before a donor cord blood transplant (CBT) helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening in patients with high-risk hematologic diseases.

Eligibility criteria

Qualifiers

Patients aged 6 months to =< 65 years at time of consent.

Complete first remission (CR1), complete second remission (CR2) or greater (CR2+), must have < 5% marrow blasts at the time of transplant.

Patients in morphologic remission with persistent cytogenetic, flow cytometric, or molecular aberrations are eligible.

Presence of any high-risk cytogenetic abnormalities such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23) or other high-risk molecular abnormality.

Disqualifiers

Diagnosis of myelofibrosis or other malignancy with moderate-severe bone marrow fibrosis.

Patients persistent with central nervous system (CNS) involvement in cerebrospinal fluid (CSF) or CNS imaging at time of screening0

Prior checkpoint inhibitors/ blockade in the last 12 months.

Two prior stem cell transplants of any kind.

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Bone Marrow Aspirate
  • Cyclophosphamide
  • Cyclosporine
  • Diagnostic Imaging
  • Echocardiography
  • Fludarabine Phosphate
  • Multigated Acquisition Scan
  • Mycophenolate Mofetil
  • Survey Administration
  • Thiotepa
  • Total-Body Irradiation
  • Umbilical Cord Blood Transplantation

Treatment groups

54 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Fred Hutchinson Cancer Center

Lead sponsor

National Cord Blood Network

Collaborator

Source ClinicalTrials.gov