Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00085124 |
| Other study ID # |
NCI-2012-02805 |
| Secondary ID |
CALGB-10201CDR36 |
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
December 2003 |
Study information
| Verified date |
May 2024 |
| Source |
National Cancer Institute (NCI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This randomized phase III trial is studying daunorubicin, cytarabine, and oblimersen to see
how well they work compared to daunorubicin and cytarabine in treating older patients with
previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as daunorubicin
and cytarabine, work in different ways to stop cancer cells from dividing so they stop
growing or die. Oblimersen may increase the effectiveness of daunorubicin and cytarabine by
making cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and
cytarabine are more effective with or without oblimersen in treating acute myeloid leukemia.
Description:
OBJECTIVES: Primary
I. Compare outcome, in terms of overall survival, disease-free survival, event-free survival,
and complete response rate, in older patients with previously untreated acute myeloid
leukemia treated with daunorubicin and cytarabine with or without oblimersen.
Secondary I. Determine the significance of expression of select Bcl-2 family member proteins
known to be modulated by oblimersen (e.g., Bcl-2) or which potentially mediate resistance to
oblimersen (e.g., Bcl-XL or Mcl-1) in predicting clinical outcomes in patients treated with
these regimens.
II. Correlate clinical outcomes with serial changes in levels of mRNA and protein expression
of Bcl-2, its pro-apoptotic binding partner Bax, and other anti-apoptotic Bax-binding
proteins (e.g., Bcl-XL or Mcl-1) in patients treated with these regimens.
III. Determine the effect of pre-treatment characteristics (e.g., morphology, cytogenetics,
molecular features, expression of multidrug resistance molecules, functional assays of drug
efflux, prior myelodysplastic syndromes, age, and white blood cells) on toxicity of these
regimens and outcomes in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment
arms.
Arm I:
Remission induction therapy: Patients receive oblimersen IV continuously on days 1-10,
cytarabine IV continuously on days 4-10, and daunorubicin IV on days 4-6.
Patients who achieve complete remission (CR) proceed to consolidation therapy. Patients who
do not achieve CR receive a second course of induction therapy.
Second remission induction therapy: Patients receive oblimersen IV continuously on days 1-8,
cytarabine IV continuously on days 4-8, and daunorubicin IV on days 4-5.
Patients who achieve CR proceed to consolidation therapy.
Consolidation therapy: Patients receive oblimersen IV continuously on days 1-8 and high-dose
cytarabine IV over 3 hours on days 4-8. Patients with a continuing CR receive a second course
of consolidation therapy.
Arm II:
Remission induction therapy: Patients receive cytarabine IV continuously on days 1-7 and
daunorubicin IV on days 1-3.
Patients who achieve CR proceed to consolidation therapy. Patients who do not achieve CR
receive a second course of induction therapy.
Second remission induction therapy: Patients receive cytarabine IV continuously on days 1-5
and daunorubicin IV on days 1 and 2.
Patients who achieve CR proceed to consolidation therapy.
Consolidation therapy: Patients receive high-dose cytarabine IV over 3 hours on days 1-5.
Patients with a continuing CR receive a second course of consolidation therapy.
In both arms, treatment continues in the absence of disease progression, unacceptable
toxicity, failure to achieve CR after 2 courses of remission induction therapy, the presence
of leukemic cells in the cerebrospinal fluid, leukemic regrowth, or relapse during
consolidation therapy.
Patients are followed every 2 months for 2 years, every 3 months for 2 years, and then
annually for 10 years.
PROJECTED ACCRUAL: A total of 500 patients (250 per treatment arm) will be accrued for this
study within 4.2 years.
