Pre-Transplant Clofarabine + Melphalan for Myelodysplastic Syndrome and Leukemia

Recruiting in Palo Alto (17 mi)

Overseen byMonzr Al Malki

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well clofarabine and melphalan before a donor stem cell transplant works in treating patients with a decrease in or disappearance of signs and symptoms of myelodysplasia or acute leukemia (disease is in remission), or chronic myelomonocytic leukemia. Giving chemotherapy, such as clofarabine and melphalan, before a donor stem cell transplant helps stop the growth of 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 a patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving clofarabine and melphalan before transplant may help prevent the cancer from coming back after transplant, and they may cause fewer side effects than standard treatment.

Research Team

Monzr Al Malki

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for patients with myelodysplasia, acute leukemia in remission, or chronic myelomonocytic leukemia who haven't had a previous transplant. They must have good kidney and liver function, heart and lung capacity, an HLA-matched donor available, and be able to understand the study. Pregnant women or those with significant health issues like HIV are excluded.

Inclusion Criteria

The stem cells used for donation can come from either the blood or the bone marrow.

You rely on regular blood transfusions to maintain your health.

You have a type of blood disorder called therapy-related MDS or MDS that developed from another blood disorder, except for myelofibrosis.

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Exclusion Criteria

Patients who have received a prior autologous or allogeneic transplant are excluded

Patients with significant hepatic dysfunction (not meeting liver function tests [LFT] eligibility criteria)

Patients with MDS evolved into AML that is not in remission

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Treatment Details

Interventions

Clofarabine (Alkylating agents)
Melphalan (Alkylating agents)
Sirolimus (Immunosuppressant)
Tacrolimus (Immunosuppressant)

Trial OverviewThe effectiveness of clofarabine and melphalan chemotherapy before receiving stem cells from a donor is being tested. The goal is to see if this treatment can help stop cancer growth while preventing rejection of the new stem cells which could rebuild healthy blood cells.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (clofarabine, melphalan, transplant)Experimental Treatment6 Interventions

CONDITIONING REGIMEN: Patients receive clofarabine IV over 2 hours on days -9 to -5 and melphalan IV over 30 minutes on day -4. TRANSPLANT: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS: Beginning on day -3, patients receive tacrolimus IV or PO and sirolimus PO once daily with taper per City of Hope standard operating procedure.