Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096148
Status:
TERMINATED
Last Update Posted:
2013-01-24
First Post:
2004-11-09
Brief Title:
Idarubicin and Cytarabine With or Without Bevacizumab in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Phase II Trial of Idarubicin Ara-C - Bevacizumab in Patients Age 60 With Untreated Acute Myeloid Leukemia
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Drugs used in chemotherapy such as idarubicin and cytarabine work in different ways to stop cancer cells from dividing so they stop growing or die Bevacizumab may stop the growth of cancer by stopping blood flow to the leukemic cells in the bone marrow Giving idarubicin and cytarabine with bevacizumab may kill more cancer cells It is not yet know whether giving idarubicin together with cytarabine is more effective with or without bevacizumab in treating acute myeloid leukemia This randomized phase II trial is studying how well giving idarubicin and cytarabine together with bevacizumab works compared to idarubicin and cytarabine alone in treating patients with newly diagnosed acute myeloid leukemia
Detailed Description:
PRIMARY OBJECTIVES
I Compare the activity of idarubicin and cytarabine with or without bevacizumab in patients with newly diagnosed acute myeloid leukemia
II Compare the proportion of patients who survive and remain in first complete remission CR one year from achieving CR after treatment with these regimens
SECONDARY OBJECTIVES
I Compare the safety of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to age 45 vs 45 to 59 cytogenetics normal vs -5-7 vs other flt 3 status normal vs mutated and type of acute myeloid leukemia AML de novo vs secondary arising after cytotoxic therapy or after an antecedent hematologic disorder defined as a documented abnormality in blood count for 3 months before diagnosis of AML Patients who require treatment before cytogenetics or flt 3 status is known eg patients with WBC 50000 OR with organ dysfunction thought to be due to blast infiltration are stratified only according to age and type of AML Induction therapy Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive idarubicin IV over 1 hour on days 1-3 and cytarabine IV continuously over 24 hours on days 1-4
Arm II Patients receive idarubicin and cytarabine as in arm I Patients also receive bevacizumab IV over 30-90 minutes on day 1 Patients who do not achieve complete remission CR after the first induction course may receive a second induction course approximately 28 days later Patients who do not achieve CR after 2 courses are removed from the study
NOTE Patients in arm II receive bevacizumab independently of chemotherapy administration schedule once every 21 days for 1 year from CR date
Post-CR therapy All patients receive 4 post-CR chemotherapy courses approximately every 28 days in the absence of disease progression or unacceptable toxicity
Course 1 Patients receive cytarabine IV continuously over 24 hours on days 1-5
Course 2 and 4 Patients receive idarubicin IV over 1 hour and cytarabine IV continuously over 24 hours on days 1-4
Course 3 Patients receive idarubicin IV over 1 hour and cytarabine IV continuously over 24 hours on days 1-2 After completion of the 4 post-CR chemotherapy courses patients in arm I induction therapy do not receive further therapy Patients in arm II induction therapy continue to receive bevacizumab as described aboveAfter completion of study treatment patients are followed every 3 months for 2 years
PROJECTED ACCRUAL A total of 60-120 patients 30-60 per treatment arm will be accrued for this study within 12-30 months
I Compare the activity of idarubicin and cytarabine with or without bevacizumab in patients with newly diagnosed acute myeloid leukemia
II Compare the proportion of patients who survive and remain in first complete remission CR one year from achieving CR after treatment with these regimens
SECONDARY OBJECTIVES
I Compare the safety of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to age 45 vs 45 to 59 cytogenetics normal vs -5-7 vs other flt 3 status normal vs mutated and type of acute myeloid leukemia AML de novo vs secondary arising after cytotoxic therapy or after an antecedent hematologic disorder defined as a documented abnormality in blood count for 3 months before diagnosis of AML Patients who require treatment before cytogenetics or flt 3 status is known eg patients with WBC 50000 OR with organ dysfunction thought to be due to blast infiltration are stratified only according to age and type of AML Induction therapy Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive idarubicin IV over 1 hour on days 1-3 and cytarabine IV continuously over 24 hours on days 1-4
Arm II Patients receive idarubicin and cytarabine as in arm I Patients also receive bevacizumab IV over 30-90 minutes on day 1 Patients who do not achieve complete remission CR after the first induction course may receive a second induction course approximately 28 days later Patients who do not achieve CR after 2 courses are removed from the study
NOTE Patients in arm II receive bevacizumab independently of chemotherapy administration schedule once every 21 days for 1 year from CR date
Post-CR therapy All patients receive 4 post-CR chemotherapy courses approximately every 28 days in the absence of disease progression or unacceptable toxicity
Course 1 Patients receive cytarabine IV continuously over 24 hours on days 1-5
Course 2 and 4 Patients receive idarubicin IV over 1 hour and cytarabine IV continuously over 24 hours on days 1-4
Course 3 Patients receive idarubicin IV over 1 hour and cytarabine IV continuously over 24 hours on days 1-2 After completion of the 4 post-CR chemotherapy courses patients in arm I induction therapy do not receive further therapy Patients in arm II induction therapy continue to receive bevacizumab as described aboveAfter completion of study treatment patients are followed every 3 months for 2 years
PROJECTED ACCRUAL A total of 60-120 patients 30-60 per treatment arm will be accrued for this study within 12-30 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000391189 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM62204 |
| MDA-2004-0342 | None | None | None |
| N01CM62202 | NIH | None | None |
| N01CM62204 | NIH | None | None |