Stem Cell Transplant after Chemotherapy and Radiation for Blood Cancers

Recruiting in Palo Alto (17 mi)

Overseen byUsama Gergis, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This clinical trial studies the use of reduced intensity chemotherapy and radiation therapy before donor stem cell transplant in treating patients with hematologic malignancies. Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine phosphate, before a donor stem cell transplant may help stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Reducing the intensity of the chemotherapy and radiation may also reduce the side effects of the donor stem cell transplant.

Eligibility Criteria

This trial is for patients with various blood cancers or bone marrow disorders who have responded to initial treatments. They must have a partially matched related donor, good heart and lung function, normal liver enzymes, adequate kidney function, and agree to use contraception if needed. Excluded are those with other active cancers (except minor skin cancer), HIV positive individuals, certain performance status levels based on age, or anyone unable to consent.

Inclusion Criteria

You have aplastic anemia.

You have certain types of anemia called refractory anemia or refractory anemia with ring sideroblasts, or isolated 5q-.

Patients must be willing to use contraception if they have childbearing potential

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Exclusion Criteria

You have taken alemtuzumab or antithymocyte globulin within 8 weeks before the transplant.

You have HIV.

You have a lower level of physical ability based on your age.

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Treatment Details

Interventions

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

Trial OverviewThe study tests whether lower doses of chemotherapy drugs like cyclophosphamide and fludarabine followed by radiation therapy can prepare patients for a stem cell transplant from a donor. The goal is to reduce cancer growth while minimizing rejection of the transplanted cells and side effects.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: RIC HSCT, GVHD prophylaxisExperimental Treatment9 Interventions

RIC: Patients receive fludarabine phosphate IV on days -10 to -8 and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI followed by a DLI on day -6. TRANSPLANT: Patients undergo CD34+ peripheral blood stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus PO beginning day -1 with a taper initiated on day 42 and mycophenolate mofetil IV BID on days -1 to 28 in the absence of GVHD.

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

🇺🇸 Approved in United States as Cytoxan for: