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NCT00900380 Clinical Trial

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

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00900380
Other study ID # CDR0000478869
Secondary ID ECOG-E3999T1
Status Completed
Phase N/A
First received May 9, 2009
Last updated May 17, 2017
Start date March 28, 2006
Est. completion date December 30, 2013

Study information
Verified date May 2017
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 30, 2013
Est. primary completion date December 30, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• flow cytometry

• immunological diagnostic method

• laboratory biomarker analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
ECOG-ACRIN Cancer Research Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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