Study of Bone Marrow and Blood Samples in Patients With Untreated Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Enrolled on Clinical Trial CALGB-9621 or CALGB-9720
- Conditions
- Leukemia
- Interventions
- Other: laboratory biomarker analysis
- Registration Number
- NCT01004965
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
This research study is looking at bone marrow and blood samples in patients with untreated acute myeloid leukemia or acute lymphoblastic leukemia enrolled on clinical trial CALGB-9621, CALGB-9720, CALGB 19808, and CALGB 10201. Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
- Detailed Description
OBJECTIVES:
I. Determine Pgp antigen expression and Pgp-mediated functional multidrug resistance (MDR) in pretreatment acute myeloid leukemia (AML) cells from adult patients enrolled on CALGB clinical trials of PSC-833 Pgp modulation.
II. Correlate Pgp-mediated MDR with patient pretreatment characteristics including age, immunophenotype, and karyotype.
III. Correlate Pgp expression, function, and in vitro modulation by PSC-833 with treatment outcome in previously untreated AML patients treated on CALGB Pgp modulation trials.
IV. Determine Pgp expression and function in AML cells from patients with refractory or relapsed leukemia following induction chemotherapy administered with or without PSC-833.
V. Correlate acquisition of drug resistance with changes in expression of other antigens and gain or loss of leukemic populations at relapse in these patients.
VI. Determine the role of other mediators, including multidrug resistance-associated protein (MRP) and lung-resistance protein (LRP), in mediating MDR in these patients at diagnosis and with relapsed or refractory disease after induction chemotherapy with or without PSC-833.
VII. Determine the frequency of Pgp-, MRP-, and LRP- mediated MDR in adult acute lymphoblastic leukemia cells and correlate this frequency with pretreatment characteristics and treatment outcome in these patients.
OUTLINE:
Samples are obtained: 1) pretreatment, 2) at the time of documentation of refractory disease in acute myeloid leukemia (AML) patients who do not achieve complete response (CR) after induction therapy, and 3) at the time of first relapse in patients who achieve CR.
Marrow cells are preferentially used for all samples, but peripheral blood is acceptable if marrow is not available and the blood contains 20% or more blasts. Pgp expression is measured using flow cytometry. AML samples are analyzed by immunoenzyme techniques (IET) using antibodies to CD33, CD34, and MRK16. B-lineage acute lymphoblastic leukemia (ALL) samples are analyzed by IET using antibodies to CD19, CD34, and MRK16. The antibodies used to analyze T-cells include CD7 and CD34. Pgp function is measured by growing cells in the presence of PSC-833 in vitro and then measuring Pgp expression as above. Multidrug resistance-associated protein (MRP) is measured using IET with the MRPm6 antibody. Lung-resistance protein (LRP) is measured with IET and the LRP56 antibody. These results are correlated with flow cytometry results.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2034
- Previously untreated patients eligible for and registered to a CALGB multidrug resistance modulation treatment protocol for acute myeloid leukemia (CALGB 9621, CALGB-9720, CALGB-19808, and CALGB 10201) OR protocols for previously untreated acute lymphocytic leukemia
- Performance status: not specified
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 laboratory biomarker analysis Samples are obtained: 1) pretreatment, 2) at the time of documentation of refractory disease in acute myeloid leukemia (AML) patients who do not achieve complete response (CR) after induction therapy, and 3) at the time of first relapse in patients who achieve CR. Marrow cells are preferentially used for all samples, but peripheral blood is acceptable if marrow is not available and the blood contains 20% or more blasts.
- Primary Outcome Measures
Name Time Method completion rate Up to 5 years
- Secondary Outcome Measures
Name Time Method duration of completion rate Up to 5 years survival Up to 5 years
Trial Locations
- Locations (46)
CancerCare of Maine at Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Shawnee Mission Medical Center
🇺🇸Shawnee Mission, Kansas, United States
Union Hospital Cancer Program at Union Hospital
🇺🇸Elkton, Maryland, United States
Saint Luke's East - Lee's Summit
🇺🇸Lee's Summit, Missouri, United States
Menorah Medical Center
🇺🇸Overland Park, Kansas, United States
Liberty Hospital
🇺🇸Liberty, Missouri, United States
Don Monti Comprehensive Cancer Center at North Shore University Hospital
🇺🇸Manhasset, New York, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Queens Cancer Center of Queens Hospital
🇺🇸Jamaica, New York, United States
Fort Wayne Medical Oncology and Hematology
🇺🇸Fort Wayne, Indiana, United States
Saint Luke's Hospital - South
🇺🇸Overland Park, Kansas, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Tunnell Cancer Center at Beebe Medical Center
🇺🇸Lewes, Delaware, United States
Heartland Regional Medical Center
🇺🇸Saint Joseph, Missouri, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Cancer Institute of New Jersey at Cooper - Voorhees
🇺🇸Voorhees, New Jersey, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Memorial Hospital of Rhode Island
🇺🇸Pawtucket, Rhode Island, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States
Monter Cancer Center of the North Shore-LIJ Health System
🇺🇸Lake Success, New York, United States
Saint Joseph Oncology, Incorporated
🇺🇸Saint Joseph, Missouri, United States
CCOP - Hematology-Oncology Associates of Central New York
🇺🇸East Syracuse, New York, United States
Kinston Medical Specialists
🇺🇸Kinston, North Carolina, United States
Naval Medical Center - San Diego
🇺🇸San Diego, California, United States
Masonic Cancer Center at University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
University of Illinois Cancer Center
🇺🇸Chicago, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Methodist Estabrook Cancer Center
🇺🇸Omaha, Nebraska, United States
CCOP - Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Truman Medical Center - Hospital Hill
🇺🇸Kansas City, Missouri, United States
Saint Luke's Cancer Institute at Saint Luke's Hospital
🇺🇸Kansas City, Missouri, United States
St. Joseph Medical Center
🇺🇸Kansas City, Missouri, United States
North Kansas City Hospital
🇺🇸Kansas City, Missouri, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Research Medical Center
🇺🇸Kansas City, Missouri, United States
Heartland Hematology Oncology Associates, Incorporated
🇺🇸Kansas City, Missouri, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
McLeod Regional Medical Center
🇺🇸Florence, South Carolina, United States