IRB #

IRB00007422

Title

A Randomized, Multi-Center, Phase III Study of Allogeneic Stem Cell Transplantation Comparing Regimen Intensity in Patients with Myelodysplastic Syndrome or Acute Myeloid Leukemia

Principal Investigator

Gabrielle Meyers

Study Purpose

The purpose of this study is to find out what effects (good and bad) the two kinds of treatments prior to transplant has on patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). This research is being done to improve the outcomes of patients diagnosed with AML and MDS.

The standard treatments to destroy diseased cells and prepare the body before transplant are called the conditioning regimens. They are used by stem cell transplant doctors worldwide and are not experimental. This research study will attempt to use different regimens and measure how well the disease (AML or MDS) responds to it.

Combinations of chemotherapy drugs and sometimes radiation are used as a treatment to destroy undetectable cancer cells and help donor cells engraft and start growing in your bone marrow. In stem cell transplant, donor’s immune cells can also recognize cancer cells and kill them. Depending on the combination used, each treatment can have a different intensity or strength. High intensity treatment uses high doses of chemotherapy or radiation and reduced intensity treatment uses lower doses. Subjects will be randomly assigned with either a high or a reduced intensity regimen before their transplant.

High intensity regimens (myeloablative conditioning – MAC) work well to destroy cancer cells but can also have more side effects during and after the transplant because of very high amounts of chemotherapy/radiation used. On the other hand, studies have shown that with reduced intensity conditioning (RIC) regimens, immune cells during the transplant can help destroy remaining cancer cells. Because the killing effects may be lower, patients can have fewer serious problems from the chemotherapy drugs. Some people require RIC regimens over MAC regimens due to their age or medical problems.

Medical Condition(s)

Myelodysplastic Syndrome or Acute Myeloid Leukemia

Eligibility Criteria

Age ≤ 65 years and ≥ 18 years

Patients with the diagnosis of high grade MDS (>5% myeloblasts at any time), or AML in morphologic complete remission.

Patients with the diagnosis of low grade MDS (bone marrow myeloblasts never >5%) in morphologic complete remission.

 Patients must be undergoing a related or unrelated bone marrow or peripheral blood transplant.

Patient must not have had a prior allograft or autograft.

Other eligibility criteria will apply.

Age Range

18 - 65

Healthy Volunteers Needed

No

Duration of Participation

Participant's general health, medical history, and current medications will be evaluated. They will need to go to clinic for evaluations. These evaluations will be done if they are in the hospital ward or clinic, or if their disease becomes active again after the transplant. After their transplant they will have weekly evaluations for the first 3 months of this study. After 3 months, they will have an evaluation at 6, 12 and 18 months after their transplant. Patients will be followed for 5 years post-transplant.

Minors Included

No

Contact

Carmen Dahlberg: 503-494-3358 or dahlberg@ohsu.edu

Sponsor

Blood and Marrow Transplant Clinical Trials Network (BMT CTN).

Recruitment End

Compensation Provided

No