Stem Cell Transplant + Chemotherapy for Leukemia and Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen byMaureen Ross

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Roswell Park Cancer Institute

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase Ib/2 trial studies how well chemotherapy, total body irradiation, and post-transplant cyclophosphamide work in reducing rates of graft versus host disease in patients with hematologic malignancies undergoing a donor stem cell transplant. Drugs used in the chemotherapy, such as fludarabine phosphate and melphalan hydrochloride, 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. Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer 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 (called graft versus host disease). Giving cyclophosphamide after the transplant may stop this from happening.

Eligibility Criteria

This trial is for patients with various blood cancers or bone marrow disorders who have a compatible donor for stem cell transplant. They should be in certain disease states, like remission or very good partial response, and have adequate organ function. Participants must not be HIV positive, pregnant, nursing, or have severe myelofibrosis; they need to understand the study and agree to use birth control.

Inclusion Criteria

My leukemia is in partial remission, or my multiple myeloma is responding well to treatment.

Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately

I am able to care for myself but cannot do normal activities or work.

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Exclusion Criteria

Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study intervention

Your doctor thinks you may have a hard time following the rules for stem cell transplantation due to serious mental health issues or difficult social circumstances.

I am HIV positive.

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Treatment Details

Interventions

Cyclophosphamide (Alkylating agents)
Fludarabine Phosphate (Anti-metabolites)
Melphalan Hydrochloride (Alkylating agents)
Mycophenolate Mofetil (Other)
Sirolimus (Other)
Total-Body Irradiation (Radiation)

Trial OverviewThe trial tests if chemotherapy combined with total body irradiation and post-transplant cyclophosphamide can reduce graft versus host disease after a donor stem cell transplant. It includes drugs like fludarabine phosphate and melphalan hydrochloride that stop cancer cells from growing.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Prevention (chemotherapy, TBI, cyclophosphamide)Experimental Treatment8 Interventions

CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1. STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.