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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by National Cancer Institute (NCI).
Recruitment status was:  Not yet recruiting
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: May 9, 2009
Last updated: NA
Last verified: October 2007
History: No changes posted

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.

Condition Intervention
Other: flow cytometry
Other: immunological diagnostic method
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Comparison of P-gp Efflux and Accumulation Assay Results With ECOG 3999 Leukemia Samples

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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

Estimated Enrollment: 40
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • Not specified


  • Not specified
  Contacts and Locations
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Please refer to this study by its identifier: NCT00900380

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Elisabeth Paietta, PhD Our Lady of Mercy Medical Center
  More Information Identifier: NCT00900380     History of Changes
Other Study ID Numbers: CDR0000478869
Study First Received: May 9, 2009
Last Updated: May 9, 2009

Keywords provided by National Cancer Institute (NCI):
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)

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms processed this record on April 28, 2017