Multidrug Resistance Genes in Patients With Acute Myeloid Leukemia

NCT00898456 | Active Not Recruiting

• 4 other identifiers: CALGB-20501U10CA031946U10CA180821CDR0000514506
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

This research trial studies multidrug resistance genes in patients with acute myeloid leukemia. Studying samples of bone marrow or blood from patients with cancer in the laboratory may help doctors learn more about changes that may occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer. It may also help doctors learn more about drug resistance and how patients respond to treatment.

Conditions

Leukemia

Keywords

adult acute myeloid leukemia; adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); adult acute minimally differentiated myeloid leukemia (M0); adult acute myeloblastic leukemia without maturation (M1); adult acute myeloblastic leukemia with maturation (M2); adult acute myelomonocytic leukemia (M4); adult acute monoblastic leukemia (M5a); adult acute monocytic leukemia (M5b); adult erythroleukemia (M6a); adult pure erythroid leukemia (M6b); adult acute megakaryoblastic leukemia (M7); adult acute basophilic leukemia; adult acute eosinophilic leukemia

Outcome Measures

Primary Outcomes (2)

• Correlation of common single nucleotide polymorphisms (SNPs) and haplotypes of the 3 multidrug resistance genes (P-glycoprotein [Pgp], multidrug resistance-associated protein (MRP-1) and breast cancer resistance protein [BCRP]) with treatment outcome

  Baseline

• Effect of ATP-binding cassette (ABC) B1, ABCC1, and ABCG2 polymorphisms on treatment outcome

  Baseline

Secondary Outcomes (3)

• Association of ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes with Pgp, MRP-1, and BCRP function and expression in pre-treatment blasts

  Baseline

• Effect of ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes on Pgp, MRP-1, and BCRP function

  Baseline

• Association of additional candidate genes relevant to etoposide, cytarabine, and daunorubicin with chemotherapy response and toxicity

  Baseline

Study Arms (1)

Group 1

Leukemia blast cells obtained from bone marrow aspirate or peripheral blood at diagnosis are used to study polymorphisms and haplotypes of ATP-binding cassette (ABC) B1, ABCC1, ABCG2, and other candidate genes. Multidrug resistance (MDR) protein expression and function are also analyzed using leukemia blast cells from patients enrolled on CALGB-9760.

Genetic: gene expression analysis; Genetic: molecular genetic technique; Genetic: polymorphism analysis; Genetic: protein expression analysis; Other: diagnostic laboratory biomarker analysis

Interventions

gene expression analysis GENETIC

Group 1

molecular genetic technique GENETIC

Group 1

polymorphism analysis GENETIC

Group 1

protein expression analysis GENETIC

Group 1

diagnostic laboratory biomarker analysis OTHER

Group 1

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute myeloid leukemia enrolled on CALGB-9621, CALGB-9720, or CALGB-19808

DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia * Treated on protocols CALGB-9621, CALGB-9720, or CALGB-19808 * Registered on the mandatory companion Leukemia Tissue Bank Protocol CALGB-9665 * Registration on another companion trial, CALGB-9760, (Multidrug Resistance Studies in Acute Leukemia) allowed PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46845, United States

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute; Congenital Abnormalities; Leukemia, Myelomonocytic, Acute; Leukemia, Monocytic, Acute; Leukemia, Erythroblastic, Acute; Leukemia, Megakaryoblastic, Acute; Leukemia, Basophilic, Acute; Leukemia, Eosinophilic, Acute

Interventions

Gene Expression Profiling; Genetic Testing; Amplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Myeloproliferative Disorders; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services; DNA Fingerprinting; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques

Study Officials

• Maria R. Baer, MD

  University of Maryland Greenebaum Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: October 1, 2006
• Primary Completion (Estimated): January 1, 2100
• Last Updated: August 18, 2023

Record last verified: 2023-08

Locations

US (1)