Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT00898456 |
| Other study ID # |
CALGB-20501 |
| Secondary ID |
CALGB-20501U10CA |
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 2006 |
Study information
| Verified date |
August 2023 |
| Source |
Alliance for Clinical Trials in Oncology |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
PRIMARY OBJECTIVES:
I. To investigate the association of common single nucleotide polymorphisms (SNPs) and
haplotypes of the three multidrug resistance (MDR) genes with treatment outcome in the
clinical studies.
II. To assess the effect of ATP-binding cassette (ABC) B1, ABCC1, and ABCG2 polymorphisms and
haplotypes on treatment outcome in younger patients enrolled on Cancer and Leukemia Group B
(CALGB) 9621 and 19808.
III. To assess the effect of ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes on
treatment outcome in older patients enrolled on CALGB 9720.
SECONDARY OBJECTIVES:
I. To test the hypothesis that ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes are
associated with phosphoglycolate phosphatase (Pgp), multidrug resistance protein 1 (MRP-1),
and ATP-binding cassette, sub-family G (WHITE), member 2 (Junior blood group) (BCRP) function
and expression in pre-treatment blasts from acute myeloid leukemia (AML) patients.
II. To assess the effect of ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes on PGP,
MRP-1, and BCRP function through CALGB 9760 in younger patients enrolled on CALGB 9621 and
19808.
III. To assess the effect of ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes on PGP,
MRP-1, and BCRP function through CALGB 9760 in older patients from CALGB 9720.
IV. To conduct an exploratory analysis of the association of additional candidate genes
relevant to etoposide, cytarabine, and daunorubicin with chemotherapy response and toxicity.
OUTLINE:
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.
PROJECTED ACCRUAL: Tissue samples from over 600 patients will be accrued for this study.
