Clinical Protocols
Protocol Number 1690 - Examination of Genetic Markers for the Development of Relapse in Patients with Leukemia and Immunological Responses to Leukemia
Investigators
- (PI) Derek Stirewalt, MD, Assistant Member, FHCRC (667-5386), Assistant Professor, UW
- Kathleen K Shannon Dorcy (Clinical Research Coordinator) FHCRC (phone 667-3648, pager 994-6628)
- Shelly Heimfeld, PhD, Associate Member, FHCRC; Brent Wood, MD, PhD, Assistant Professor, UW
- Thomas Chauncey, MD, PhD, Associate Member, FHCRC, Assistant Professor, UW
- Stephen Petersdorf, MD, Associate Member, FHCRC, Associate Professor, UW
- Michael Linenberger, MD, Associate Member, FHCRC, Associate Professor, UW
- Soheil Meshinchi, MD, PhD, Assistant Member, FHCRC, Assistant Professor
- Vivian Oehler, MD, Hematology Fellow, FHCRC, (667-1340
- Jerald Radich, MD, Member, FHCRC, Professor, UW
- Stanley Riddell, MD, Member, F.H.C.R.C, Professor U.W
- Marie Bleakley, MD, Acting Instructor, UW, Research Associate, FHCRC
- Michael Liao, MD, PhD, Affiliate (253-841-4296)
- Colette Chaney, RN, Clinical Research Nurse
Objectives
- Assess the prognostic significance of mutations, translocations, and gene expression patterns in patients with leukemia.
- Identify novel genes that may be important in predicting relapse after treatment and may be potential markers for MRD.
- Retrospectively evaluate the sensitivity and clinical relevance of newly identified molecular markers following treatment for leukemia.
- Evaluate the effect of antigen specific T cells on leukemia in vitro, and in NOD SCID mice.
Patient Selection Inclusions: All adult patients with a suspected diagnosis or confirmed diagnosis of either acute or chronic leukemia are eligible. Patients must have evidence of active leukemia at the time of the initial sample acquisition. Patients with newly diagnosed, relapsed, refractory, or persistent leukemia are eligible. Because many forms of leukemia are relatively uncommon, we will also include previously collected diagnostic samples from patients treated at the SCCA and UW. These retrospective samples will only be used if the patient signed consent allowing the use and distribution of biological materials for research purposes.
Exclusions: Adult leukemia patients who have not consented or those deemed unable to give consent for the study as judged by their attending physician.
Study Design and Sample Collection
Initial Peripheral Blood and Bone Marrow Samples
Patients at the time of initial evaluation will have an additional 5 ml (1 teaspoon) of bone marrow aspirate and 42 ml ( 8 teaspoons) of peripheral blood collected prior to treatment. If patients require leukapheresis prior to starting treatment, the leukapheresis samples can also be used for this study. As per standard practice, all patients undergo an extensive evaluation for treatment of their leukemia in either the outpatient or inpatient department. Blood tests and bone marrow evaluation prior to treatment are standard practice for the treatment of leukemia; thus, the samples required for this study will not necessitate additional bone marrow procedures or peripheral blood "sticks."
Future Blood Samples
Patients with leukemia routinely have daily blood draws during their induction or treatment. All patients will have an additional 14-21 ml (2-3 teaspoons) of blood drawn the day after their first dose of treatment. For patients with acute leukemia undergoing induction chemotherapy or patients undergoing transplantation, the patient will then have an additional 14-21 ml (2-3 teaspoons) of peripheral blood obtained once patients have recovered their neutrophil count (ANC > 1500) and are off of growth factors. For patients with chronic leukemia or patients receiving chronic daily chemotherapy, an additional 14-21 ml (2-3 teaspoons) of peripheral blood will be obtained one month after the first dose of treatment. Also, an additional 42 ml ( 8 teaspoons) of blood will be obtained at the time of any leukemia relapse. Blood tests are standard practice for follow-up of patients with leukemia; thus, the peripheral blood samples required for this study will probably not necessitate additional peripheral blood "sticks."
Future Bone Marrow Samples
Patients routinely have bone marrow aspiration post-treatment to determine disease states. An additional 5 ml (1 teaspoons) of bone marrow aspirate will be obtained at the time of any scheduled bone marrow aspiration deemed clinically necessary. Our collection will not require additional needle "sticks" or procedures.
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