09MRD - The Role of Minimal Residual Disease Testing before and after Hematopoietic Cell Transplantation for Pediatric Acute Myeloid Leukemia (IRB# 38709)
- Principal Investigator: Robert J. Greiner, M.D.
For this study, we will be looking at how well two different tests (flow cytometry and WT1 testing) measure small amounts of cancer cells that may still be in the patient's blood and/or bone marrow before and after transplant. In flow cytometry, a sample of bone marrow is run through a machine which analyzes the cells to see if any abnormal cells are present. If there are abnormal cells present, an additional test called a chimerism assay will be done to see if the abnormal cells are from the donor or from the patient. WT1 is a marker that is often seen on leukemia cells. WT1 testing will use a sample of the patient's blood and marrow to look for that cancer marker. Looking at the results of flow cytometry and WT1 testing before and after the transplant may give us a better idea of how well the patient's disease responds to the transplant.
- informed consent
- Age 0-21 at time of transplant
- Karnofsky score = 70% (age = 16 years old), or Lansky score = 70% (age<16 years old)
- Patients with adequate physical function as measured by: (Cardiac, Hepatic, Renal and Pulmonary)
- AML at the following stages (High risk first complete remission, Intermediate risk first complete remission, High risk based upon COG AAML 1031 criteria, Second or greater CR, Therapy-related AML at any stage)
- Myeloablative preparative regimen
- Graft source.
Additional Study Details:
To participate in this research study, the patient will be asked to give about 1 teaspoon (6-8ml) of bone marrow from a bone marrow test. The patient will also be asked to give about 2 teaspoons (10ml) of blood for research purposes. The doctors will try to schedule these tests for the same time as the patient's regular transplant follow-up exams.
These tests will be done at the following times:
- Before patient's transplant
- About 42 days after patient's transplant
- About 100 days after patient's transplant
Penn State Milton S. Hershey Medical Center
Pediatric Clinical Research Office