Combination Therapy for Blood Cancer

Recruiting in Palo Alto (17 mi)

Overseen bySophia Balderman

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Roswell Park Cancer Institute

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This phase II trial studies how well fludarabine phosphate, cyclophosphamide, total body irradiation, and donor stem cell transplant work in treating patients with blood cancer. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also 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. The donated stem cells may also replace the patient?s immune cells and help destroy any remaining cancer cells.

Eligibility Criteria

This trial is for patients with various blood cancers or related conditions who have a suitable related half-matched (haploidentical) donor. They must be able to tolerate radiation, have decent organ function, and not be pregnant. Those with uncontrolled diseases, recent other treatments, or prior allogeneic transplants are excluded.

Inclusion Criteria

Suitable related haploidentical donor identified per transplant service

Disease response noted (i.e. CR, non-CR, or not applicable): Assessed as per disease specific criteria

Have a Karnofsky (adult) or Lansky (for =< 16 years) performance status >= 60%

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Exclusion Criteria

You have a brain or spinal cord condition that is not under control, as determined by the principal investigator.

Pregnant or nursing female participants

Patients who in the opinion of the treating physician are unlikely to comply with the restrictions of allogeneic stem cell transplantation based on formal psychosocial screening

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Participant Groups

The study tests if fludarabine phosphate and cyclophosphamide chemotherapy combined with total body irradiation followed by stem cell transplant from a half-matched donor can treat blood cancer effectively. It aims to see if this approach helps the bone marrow recover and fight cancer better.

1Treatment groups

Experimental Treatment

Group I: Treatment (fludarabine, cyclophosphamide, TBI, PBSCT)Experimental Treatment5 Interventions

Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo TBI on days -1 and PBSCT on day 0.

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

🇺🇸 Approved in United States as Cytoxan for: