Study on Clofarabine and Melphalan Before Donor Stem Cell Transplant for Patients with Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT01885689

This clinical trial is testing how well the drugs clofarabine and melphalan work when given before a donor stem cell transplant in patients whose myelodysplasia or acute leukemia is in remission, or who have chronic myelomonocytic leukemia. The treatment aims to stop cancer cells from growing and help the body accept the donor's stem cells.

Patient Parameters

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Program Overview

The purpose of this study is to see if using the chemotherapy drugs clofarabine and melphalan before a donor stem cell transplant can help treat patients with myelodysplasia or acute leukemia in remission, or chronic myelomonocytic leukemia. These drugs may help stop cancer cells from growing and prevent the patient's immune system from rejecting the donor's stem cells. The healthy stem cells from the donor can help the patient's bone marrow produce new blood cells. This approach may also reduce the risk of cancer returning and cause fewer side effects than standard treatments.

Description

The study has several main goals:

To determine if clofarabine and melphalan, given before a stem cell transplant, can help patients live longer without the cancer coming back.
To estimate overall survival rates and the chances of cancer returning or other complications within 100 days, 1 year, and 2 years after treatment.
To summarize any side effects or complications, including graft-vs-host disease (GVHD) and infections.

Treatment Plan:

Preparation: Patients will receive clofarabine through an IV for 2 hours each day from day -9 to day -5, and melphalan through an IV for 30 minutes on day -4.
Transplant: Patients will receive the donor stem cell transplant on day 0.
GVHD Prevention: Starting on day -3, patients will take medications (tacrolimus and sirolimus) to prevent GVHD, either through an IV or by mouth.

After the treatment, patients will have follow-up visits once a week for 60 days, then at 100 and 180 days, at one year, and yearly for up to 5 years.

Eligibility Criteria

Inclusion Criteria

Patients in 1st or 2nd remission with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) eligible for stem cell transplant.
High-risk myelodysplastic syndrome (MDS) based on specific scoring systems.
Patients with chronic myelomonocytic leukemia (CMML) can join.
MDS that has evolved to AML must be in remission.
Patients not eligible for full ablative regimens.
Performance status of 70% or higher on the Karnofsky scale.
Women and men must agree to use effective birth control during and for six months after the study.
Bone marrow and blood tests must confirm diagnosis and remission status.
Adequate kidney, liver, heart, and lung function as determined by specific tests.
Availability of a suitable donor for stem cell transplant.
All patients must have a psychosocial evaluation and be able to understand and sign informed consent.

Exclusion Criteria

Patients who have had a previous stem cell transplant.
Significant liver problems or MDS that has turned into AML not in remission.
Patients with certain types of leukemia or other active cancers.
Patients with central nervous system leukemia or uncontrolled illnesses.
Pregnant or breastfeeding women.
Patients who do not agree to use effective contraception.
HIV-positive patients or those with active hepatitis B or C.
Patients who have had radiation therapy for leukemia may be ineligible.
Any medical or psychiatric issues that may interfere with treatment or follow-up.
Known allergies to study drugs or components.
Cord blood as a donor source is not allowed.

Locations

FACILITY	ZIP	CITY	STATE
City of Hope Medical Center	91010	Duarte	California

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