A Feasibility Study of Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells from Partially Matched Donors to Treat Acute Myelogenous Leukemia in Elderly Patients

Full Title

Treatment of Elderly AML Patients with Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells from Haploidentical Related Donors

Purpose

Acute myelogenous leukemia (AML) is a common bone marrow cancer in people over age 60. Chemotherapy may restore normal bone marrow function; however, less than half of patients will respond. Chemotherapy may also cause side effects from infections that occur when the white blood cell count is low. Patients who enter a remission may proceed to a bone marrow transplant (BMT). The purpose of a bone marrow transplant is to use the donor immune system to fight AML. A traditional BMT is a serious form of treatment, with side effects that may be too strong for some elderly patients.

In this study, researchers are evaluating the feasibility of using donor stem cells to fight AML without performing a full BMT. Stem cells donated by a family member, such as a sibling or adult child, are given to the patient after standard AML chemotherapy. The donor's immune cells may work with the chemotherapy to attack leukemia before the patient's own immune system recovers and rejects the donor cells. Because the patient¿s own immune system is restored, this treatment does not represent a full BMT.

This study will evaluate if donor stem cells can reduce the toxicity of chemotherapy by decreasing the period of low white blood cell count after treatment and increase the likelihood of reaching a remission. Researchers will monitor patients in this study to see how long the donor immune cells stay in the body before being destroyed by the patient's immune system.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have previously untreated AML and be age 60 or older.
  • Patients must have a child or other half-matched family member who is eligible to be a stem cell donor and is age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Brian Shaffer at 212-639-2212.

Protocol

15-141

Phase

Pilot

Investigator

Locations