Cord Blood Transplant + Chemo/Radiation for Leukemia and Lymphoma

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byAnn E. Dahlberg

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Fred Hutchinson Cancer Research Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of 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 disease. Giving chemotherapy, such as cyclophosphamide and fludarabine, and TBI before a donor umbilical cord blood transplant 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.

Eligibility Criteria

This trial is for patients with various hematologic diseases who have a specific match of human leukocyte antigens (HLA) with the umbilical cord blood donor. Adults must have a performance status score indicating they can carry out daily activities, and children must be able to perform most activities. Patients up to 65 years old may qualify depending on their disease, health conditions, and doctor's assessment. Pregnant or breastfeeding individuals, those with uncontrolled infections or HIV, or certain prior treatments are excluded.

Inclusion Criteria

I am mostly active and can care for myself.

My liver, lungs, and heart are functioning well.

I am between 6 months and 65 years old.

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Exclusion Criteria

Pregnant or breastfeeding

I have not received Y-90 ibritumomab or I-131 tostumomab as part of my treatment.

I have not had a high-dose radiation bone marrow transplant.

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Treatment Details

Interventions

Cyclophosphamide (Alkylating agents)
Cyclosporine (Immunosuppressant)
Fludarabine (Anti-metabolites)
Mycophenolate Mofetil (Immunosuppressant)
Total-Body Irradiation (Radiation Therapy)

Trial OverviewThe study tests if chemotherapy drugs like cyclophosphamide and fludarabine combined with total-body irradiation (TBI), followed by an umbilical cord blood transplant can effectively treat hematologic diseases. It also looks at preventing immune reactions against the patient's body using medications such as cyclosporine and mycophenolate mofetil after the transplant.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Treatment (myeloablative UCBT)Experimental Treatment8 Interventions

Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single- or double-unit UCBT on day 0. Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD.

Group II: Arm II (myeloablative UCBT)Experimental Treatment9 Interventions

Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single- or double-unit UCBT on day 0. Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD.

Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Cytoxan for: