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

May 17, 2017 updated by: ECOG-ACRIN Cancer Research Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Samples submitted for research from patients participating in E3999

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ECOG-ACRIN Cancer Research Group

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 28, 2006

Primary Completion (ACTUAL)

December 30, 2013

Study Completion (ACTUAL)

December 30, 2013

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (ESTIMATE)

May 12, 2009

Study Record Updates

Last Update Posted (ACTUAL)

May 19, 2017

Last Update Submitted That Met QC Criteria

May 17, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000478869
  • ECOG-E3999T1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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