RecruitingPhase 2NCT06013423

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

Optimized Cord Blood Transplantation for the Treatment of High-Risk Hematologic Malignancies in Adults and Pediatrics


Sponsor

Fred Hutchinson Cancer Center

Enrollment

54 participants

Start Date

Jul 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 6 MonthsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing cord blood transplantation (using blood stem cells from donated umbilical cord blood) combined with a preparation regimen of cyclophosphamide, fludarabine, and total-body irradiation for people with high-risk blood cancers and other serious blood disorders. **You may be eligible if...** - You are between 6 months and 65 years old - You have a high-risk blood cancer or blood disorder such as: AML or ALL in remission, certain forms of leukemia, myelodysplastic syndrome, lymphoma, or inherited blood or immune disorders - Your cancer is in remission or at low blast count at the time of transplant - You do not have a fully matched related donor available (cord blood is used instead) **You may NOT be eligible if...** - Your leukemia is not in remission - You have serious organ dysfunction that would make transplant too risky - You have uncontrolled infection - You are pregnant or breastfeeding - Your overall health is too poor to tolerate the transplant procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspirate

Undergo bone marrow aspirate

DRUGCyclophosphamide

Receive IV

DRUGCyclosporine

Receive IV or PO

PROCEDUREDiagnostic Imaging

Undergo diagnostic imaging

PROCEDUREEchocardiography

Undergo ECHO

DRUGFludarabine Phosphate

Receive IV

PROCEDUREMultigated Acquisition Scan

Undergo MUGA

DRUGMycophenolate Mofetil

Receive IV

OTHERSurvey Administration

Ancillary studies

DRUGThiotepa

Receive IV

RADIATIONTotal-Body Irradiation

Undergo high-dose or middle-intensity TBI

PROCEDUREUmbilical Cord Blood Transplantation

Undergo UCBT


Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06013423


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