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NCT01004965 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

Leukemia Clinical Trial

Official title:
Multidrug Resistance Studies in Acute Myeloid Leukemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01004965
Other study ID # CALGB-9760
Secondary ID U10CA031946CALGB
Status Completed
Phase
First received
Last updated
Start date March 15, 1997
Est. completion date June 16, 2010

Study information
Verified date August 2022
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 2034
Est. completion date June 16, 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• laboratory biomarker analysis

Locations
Country Name City State
United States CancerCare of Maine at Eastern Maine Medical Center Bangor Maine
United States Roswell Park Cancer Institute Buffalo New York
United States Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill North Carolina
United States Blumenthal Cancer Center at Carolinas Medical Center Charlotte North Carolina
United States University of Chicago Cancer Research Center Chicago Illinois
United States University of Illinois Cancer Center Chicago Illinois
United States CCOP - Hematology-Oncology Associates of Central New York East Syracuse New York
United States Union Hospital Cancer Program at Union Hospital Elkton Maryland
United States McLeod Regional Medical Center Florence South Carolina
United States Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana
United States Wayne Memorial Hospital, Incorporated Goldsboro North Carolina
United States Holden Comprehensive Cancer Center at University of Iowa Iowa City Iowa
United States Queens Cancer Center of Queens Hospital Jamaica New York
United States CCOP - Kansas City Kansas City Missouri
United States Heartland Hematology Oncology Associates, Incorporated Kansas City Missouri
United States North Kansas City Hospital Kansas City Missouri
United States Research Medical Center 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 Truman Medical Center - Hospital Hill Kansas City Missouri
United States Kinston Medical Specialists Kinston North Carolina
United States Monter Cancer Center of the North Shore-LIJ Health System Lake Success New York
United States CCOP - Nevada Cancer Research Foundation Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Saint Luke's East - Lee's Summit Lee's Summit Missouri
United States Tunnell Cancer Center at Beebe Medical Center Lewes Delaware
United States Liberty Hospital Liberty Missouri
United States CCOP - North Shore University Hospital Manhasset New York
United States Don Monti Comprehensive Cancer Center at North Shore University Hospital Manhasset New York
United States Masonic Cancer Center at University of Minnesota Minneapolis Minnesota
United States Long Island Jewish Medical Center New Hyde Park New York
United States Mount Sinai Medical Center New York New York
United States CCOP - Christiana Care Health Services Newark Delaware
United States Methodist Estabrook Cancer Center Omaha Nebraska
United States Menorah Medical Center Overland Park Kansas
United States Saint Luke's Hospital - South Overland Park Kansas
United States Memorial Hospital of Rhode Island Pawtucket Rhode Island
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Saint Joseph Oncology, Incorporated Saint Joseph Missouri
United States Naval Medical Center - San Diego San Diego California
United States Shawnee Mission Medical Center Shawnee Mission Kansas
United States SUNY Upstate Medical University Hospital Syracuse New York
United States Cancer Institute of New Jersey at Cooper - Voorhees Voorhees New Jersey
United States Walter Reed Army Medical Center Washington District of Columbia
United States Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary completion rate Up to 5 years
Secondary duration of completion rate Up to 5 years
Secondary survival Up to 5 years
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