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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT06013423
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Months - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Marrow Aspirate — PROCEDURE
    Undergo bone marrow aspirate
  • Cyclophosphamide — DRUG
    Receive IV
  • Cyclosporine — DRUG
    Receive IV or PO
  • Diagnostic Imaging — PROCEDURE
    Undergo diagnostic imaging
  • Echocardiography — PROCEDURE
    Undergo ECHO
  • Fludarabine Phosphate — DRUG
    Receive IV
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Mycophenolate Mofetil — DRUG
    Receive IV
  • Survey Administration — OTHER
    Ancillary studies
  • Thiotepa — DRUG
    Receive IV
  • Total-Body Irradiation — RADIATION
    Undergo high-dose or middle-intensity TBI
  • Umbilical Cord Blood Transplantation — PROCEDURE
    Undergo UCBT

Study Details

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.

Key Dates

Start date
Jul 23, 2024
Status verified
Jan 2026
Primary completion
Oct 31, 2031
Completion
Oct 31, 2032

Study Design

Enrollment
54 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (myeloablative UCBT)
    See detailed description.
  • Experimental: Arm II (myeloablative UCBT)
    See detailed description.

Primary Outcome Measure

Overall survival [ Time Frame: At 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Ann Dahlberg
[email protected]
206-667-1959
Ann Dahlberg (PRINCIPAL_INVESTIGATOR)

Find similar trials in Seattle, WA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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