Studying Tissue Samples to Learn More About Drug Resistance in Patients With Acute Myeloid Leukemia

Comparison of P-gp Efflux and Accumulation Assay Results With ECOG 3999 Leukemia Samples

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00900380

Enrollment

Registered

2009-05-12

Start date

2006-03-28

Completion date

2013-12-30

Last updated

2017-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

adult acute monocytic leukemia (M5b), adult acute megakaryoblastic leukemia (M7), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), secondary acute myeloid leukemia, untreated adult acute myeloid leukemia, adult acute minimally differentiated myeloid leukemia (M0), 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 erythroleukemia (M6a), adult pure erythroid leukemia (M6b)

Brief summary

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients. PURPOSE: This laboratory study is examining tissue samples from patients with acute myeloid leukemia to learn more about drug resistance in these patients.

Detailed description

OBJECTIVES: * Ascertain whether assessments of P-glycoprotein (P-gp) status using the accumulation assay find greater than 10% positive specimens among 30 specimens (collected from patients with acute myeloid leukemia enrolled on clinical trial ECOG-E3999) found to be negative using only the efflux assay. OUTLINE: This is a multicenter study. Cryopreserved bone marrow specimens are examined for P-glycoprotein (P-gp) by the accumulation assay and the efflux assay using DiOC\_2 dye. Flow cytometry is used for measuring activity in both assays. PROJECTED ACCRUAL: A total of 40 specimens will be accrued for this study.

Interventions

OTHERflow cytometry

OTHERimmunological diagnostic method

OTHERlaboratory biomarker analysis

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Cryopreserved bone marrow specimens collected from patients with acute myeloid leukemia enrolled on clinical trial ECOG-E3999 meeting the following criteria: * Appreciable levels of either CD34+ OR CD117+ blasts * Appreciable staining with anti-P-gp antibodies * 30 specimens must exhibit low to moderate dye loading for the Rh123 efflux assay * 10 specimens must exhibit positive Rh123 efflux activities PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Design outcomes

Primary

Measure	Time frame
Percentage of specimens collected from patients that are found to be P-glycoprotein (P-gp)-positive by accumulation assay that were found to be negative using efflux assay	1 day

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026