Acute Myeloid Leukemia Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

2034

Study ID:

NCT01004965

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 45 Locations for this study

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Naval Medical Center - San Diego
San Diego California, 92134, United States
Tunnell Cancer Center at Beebe Medical Center
Lewes Delaware, 19958, United States
CCOP - Christiana Care Health Services
Newark Delaware, 19713, United States
Walter Reed Army Medical Center
Washington District of Columbia, 20307, United States
University of Illinois Cancer Center
Chicago Illinois, 60612, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne Indiana, 46845, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City Iowa, 52242, United States
Menorah Medical Center
Overland Park Kansas, 66209, United States
Saint Luke's Hospital - South
Overland Park Kansas, 66213, United States
Shawnee Mission Medical Center
Shawnee Mission Kansas, 66204, United States
CancerCare of Maine at Eastern Maine Medical Center
Bangor Maine, 04401, United States
Union Hospital Cancer Program at Union Hospital
Elkton Maryland, 21921, United States
Masonic Cancer Center at University of Minnesota
Minneapolis Minnesota, 55455, United States
Truman Medical Center - Hospital Hill
Kansas City Missouri, 64108, United States
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City Missouri, 64111, United States
St. Joseph Medical Center
Kansas City Missouri, 64114, United States
North Kansas City Hospital
Kansas City Missouri, 64116, United States
Heartland Hematology Oncology Associates, Incorporated
Kansas City Missouri, 64118, United States
CCOP - Kansas City
Kansas City Missouri, 64131, United States
Research Medical Center
Kansas City Missouri, 64132, United States
Saint Luke's East - Lee's Summit
Lee's Summit Missouri, 64086, United States
Liberty Hospital
Liberty Missouri, 64068, United States
Heartland Regional Medical Center
Saint Joseph Missouri, 64506, United States
Saint Joseph Oncology, Incorporated
Saint Joseph Missouri, 64507, United States
Methodist Estabrook Cancer Center
Omaha Nebraska, 68114, United States
University Medical Center of Southern Nevada
Las Vegas Nevada, 89102, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees New Jersey, 08043, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse New York, 13057, United States
Queens Cancer Center of Queens Hospital
Jamaica New York, 11432, United States
Monter Cancer Center of the North Shore-LIJ Health System
Lake Success New York, 11042, United States
CCOP - North Shore University Hospital
Manhasset New York, 11030, United States
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset New York, 11030, United States
Long Island Jewish Medical Center
New Hyde Park New York, 11040, United States
Mount Sinai Medical Center
New York New York, 10029, United States
SUNY Upstate Medical University Hospital
Syracuse New York, 13210, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill North Carolina, 27599, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte North Carolina, 28232, United States
Wayne Memorial Hospital, Incorporated
Goldsboro North Carolina, 27534, United States
Kinston Medical Specialists
Kinston North Carolina, 28501, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem North Carolina, 27157, United States
Memorial Hospital of Rhode Island
Pawtucket Rhode Island, 02860, United States
McLeod Regional Medical Center
Florence South Carolina, 29501, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

2034

Study ID:

NCT01004965

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

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