Radiation Therapy + Chemotherapy Before Stem Cell Transplant for Leukemia

Recruiting in Palo Alto (17 mi)

Overseen byJoseph Rosenthal

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?This phase I trial studies the side effects and best dose of total bone marrow and lymphoid irradiation when given together with chemotherapy before donor stem cell transplant in treating patients with myelodysplastic syndrome or acute leukemia. Total marrow and lymphoid irradiation is a type of radiation therapy that targets bone marrow and blood, where the cancer is, instead of applying radiation to the whole body. Stem cell transplants use high doses of chemotherapy and radiation therapy, such as total marrow and lymphoid irradiation, to kill cancer cells, but these treatments kill normal cells as well. After chemotherapy, healthy cells from a donor are given to the patient to help the patient grow new blood cells.

Eligibility Criteria

This trial is for patients with myelodysplastic syndrome or acute leukemia who are in remission but at high risk of relapse, have good heart function and overall health, and no severe organ damage. They must be able to use birth control and have a partially matched related donor ready for stem cell donation. People with active infections or unable to tolerate certain therapies cannot participate.

Inclusion Criteria

I have been diagnosed with acute myelogenous leukemia or acute lymphocytic leukemia.

My condition is a high-risk type of blood disorder.

Patients with the ability to understand and sign a written informed consent

+5 more

Exclusion Criteria

I have a donor who is a complete or partial HLA match.

I currently have an active infection.

I have undergone more than 3 treatments to induce cancer remission.

+12 more

Participant Groups

The study tests the safety and optimal dose of total marrow and lymphoid irradiation combined with chemotherapy before a stem cell transplant from a donor. The goal is to target cancer cells in the bone marrow without harming other parts of the body too much.

1Treatment groups

Experimental Treatment

Group I: Treatment (TMLI, chemotherapy, transplant, GVHD prophylaxis)Experimental Treatment8 Interventions

CONDITIONING: Patients undergo TMLI BID on days -7 to -4 or -3 (depending on the dose level). Patients also receive fludarabine phosphate IV on days -7 to -3 and cyclophosphamide IV on days -7, -6, 3, and 4. TRANSPLANT: Patients undergo bone marrow or peripheral blood stem cell transplant on day 0. GHVD PROPHYLAXIS: Patients receive tacrolimus\* IV QD or PO BID on days 5-180. Patients also receive mycophenolate mofetil PO TID or IV on days 5-35. Treatment with tacrolimus and mycophenolate mofetil may continue in the presence of active GVHD. \*NOTE: Patients intolerant of tacrolimus may receive cyclosporine.

Bone Marrow Transplantation is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Bone Marrow Transplant for: