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Study of Bone Marrow and Bloo...

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

Last Updated: 2022-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2034 participants

Study Classification

OBSERVATIONAL

Study Start Date

1997-03-15

Study Completion Date

2010-06-16

Brief Summary

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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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Detailed Description

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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.

Conditions

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Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

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.

laboratory biomarker analysis

Intervention Type OTHER

Interventions

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laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria R. Baer, MD

Role: STUDY_CHAIR

University of Maryland Greenebaum Cancer Center

Locations

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Naval Medical Center - San Diego

San Diego, California, United States

Site Status

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, United States

Site Status

CCOP - Christiana Care Health Services

Newark, Delaware, United States

Site Status

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Site Status

University of Illinois Cancer Center

Chicago, Illinois, United States

Site Status

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Site Status

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States

Site Status

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, United States

Site Status

Menorah Medical Center

Overland Park, Kansas, United States

Site Status

Saint Luke's Hospital - South

Overland Park, Kansas, United States

Site Status

Shawnee Mission Medical Center

Shawnee Mission, Kansas, United States

Site Status

CancerCare of Maine at Eastern Maine Medical Center

Bangor, Maine, United States

Site Status

Union Hospital Cancer Program at Union Hospital

Elkton, Maryland, United States

Site Status