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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Marrow Aspirate

    Procedure/Surgery

    Undergo bone marrow aspirate

  • Cyclophosphamide

    Drug

    Receive IV

  • Cyclosporine

    Drug

    Receive IV or PO

  • Diagnostic Imaging

    Procedure/Surgery

    Undergo diagnostic imaging

  • Echocardiography

    Procedure/Surgery

    Undergo ECHO

  • Fludarabine Phosphate

    Drug

    Receive IV

  • Multigated Acquisition Scan

    Procedure/Surgery

    Undergo MUGA

  • Mycophenolate Mofetil

    Drug

    Receive IV

  • Survey Administration

    Other intervention

    Ancillary studies

  • Thiotepa

    Drug

    Receive IV

  • Total-Body Irradiation

    Radiation

    Undergo high-dose or middle-intensity TBI

  • Umbilical Cord Blood Transplantation

    Procedure/Surgery

    Undergo UCBT

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: Arm I (myeloablative UCBT)Experimental treatment 12 interventions
Group B: Arm II (myeloablative UCBT)Experimental treatment 13 interventions

Trial outcomes

Primary outcomes

1

Overall survival

Will be assessed after optimized cord blood transplant (CBT) in adults and children with hematologic malignancies. Will be calculated using the Kaplan-Meier method.

Time frame
At 1 year

Secondary outcomes

1

Cumulative incidence of neutrophil and platelet engraftment

Will be calculated within the competing risks framework considering death without neutrophil or platelet recovery, respectively, as completing events

Time frame
Up to 1 year
2

Incidences of graft failure

Will be calculated within the competing risks framework considering death without engraftment before day 21 as a competing event.

Time frame
Up to 1 year
3

Incidence of grade II-IV and III-IV acute graft-versus-host disease (aGVHD)

Will be calculated within the competing risks framework considering relapse/ death without developing GVHD, death in the absence of relapse, and relapse as competing events, respectively.

Time frame
At day 100
4

Incidence of grade II-IV and III-IV aGVHD

Will be calculated within the competing risks framework considering relapse/ death without developing GVHD, death in the absence of relapse, and relapse as competing events, respectively.

Time frame
At day 180

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fred Hutchinson Cancer Center

Lead sponsor

National Cord Blood Network

Collaborator

Source ClinicalTrials.gov
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