Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00046930
Status:
COMPLETED
Last Update Posted:
2023-07-05
First Post:
2002-10-03
Brief Title:
Daunorubicin Cytarabine - Zosuquidar inTreating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Randomized Placebo-Controlled Double Blind Trial of the Administration of the MDR Modulator Zosuquidar Trihydrochloride LY335979 During Conventional Induction and Post-Remission Therapy in Patients Greater Than 60 Years of Age With Newly Diagnosed Acute Myeloid Leukemia Refractory Anemia With Excess Blasts in Transformation or High-Risk Refractory Anemia With Excess Blasts
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Zosuquidar trihydrochloride a modulator of multidrug resistance MDR may help daunorubicin and cytarabine kill more cancer cells by making cancer cells more sensitive to the drugs It is not yet known whether daunorubicin and cytarabine are more effective with or without zosuquidar trihydrochloride in treating acute myeloid leukemia or anemia
PURPOSE This randomized phase III trial is studying how well giving zosuquidar trihydrochloride together with daunorubicin and cytarabine works compared to daunorubicin and cytarabine alone in treating older patients with newly diagnosed acute myeloid leukemia or anemia that has not responded to previous treatment
PURPOSE This randomized phase III trial is studying how well giving zosuquidar trihydrochloride together with daunorubicin and cytarabine works compared to daunorubicin and cytarabine alone in treating older patients with newly diagnosed acute myeloid leukemia or anemia that has not responded to previous treatment
Detailed Description:
OBJECTIVES
Compare the overall survival and progression-free survival of elderly patients with newly diagnosed acute myeloid leukemia refractory anemia with excess blasts RAEB in transformation or high-risk RAEB treated with daunorubicin and cytarabine with or without zosuquidar trihydrochloride
Compare the complete remission rate of patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the systemic exposure of daunorubicin and cytarabine in patients treated with zosuquidar trihydrochloride vs placebo
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to age 60-69 years vs 70 years and over disease refractory anemia with excess blasts RAEB vs RAEB in transformation or acute myeloid leukemia AML and disease type de novo vs secondary Patients are randomized to 1 of 2 treatment arms
Induction
Arm I Patients receive daunorubicin via intravenous IV infusion over 10-15 minutes and zosuquidar trihydrochloride IV over 6 hours on days 1-3 Patients also receive cytarabine IV continuously on days 1-7
Arm II Patients receive daunorubicin and cytarabine as in arm I Patients also receive placebo IV over 6 hours on days 1-3
Beginning on day 12 patients who achieve aplasia receive filgrastim G-CSF or sargramostim GM-CSF subcutaneously SC or IV daily until blood counts recover Patients who have evidence of persistent AML are eligible to receive a second identical course of induction chemotherapy
Consolidation I beginning within 8 weeks after documentation of complete remission CR or measurable remission MR Patients who achieve a CR or MR receive cytarabine IV over 1 hour once or twice daily on days 1-6 and GM-CSF or G-CSF SC or IV beginning on day 7 and continuing until blood counts recover
Consolidation II Patients who have maintained peripheral blood evidence of a remission receive daunorubicin cytarabine and zosuquidar trihydrochloride or placebo as in induction chemotherapy Patients also receive GM-CSF or G-CSF SC or IV beginning on day 8 or after last cytarabine dose and continuing until blood counts recover
Patients are followed monthly for 1 year every 2 months for 1 year every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL Approximately 450 patients 225 per treatment arm accrued over 41 years
Compare the overall survival and progression-free survival of elderly patients with newly diagnosed acute myeloid leukemia refractory anemia with excess blasts RAEB in transformation or high-risk RAEB treated with daunorubicin and cytarabine with or without zosuquidar trihydrochloride
Compare the complete remission rate of patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the systemic exposure of daunorubicin and cytarabine in patients treated with zosuquidar trihydrochloride vs placebo
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to age 60-69 years vs 70 years and over disease refractory anemia with excess blasts RAEB vs RAEB in transformation or acute myeloid leukemia AML and disease type de novo vs secondary Patients are randomized to 1 of 2 treatment arms
Induction
Arm I Patients receive daunorubicin via intravenous IV infusion over 10-15 minutes and zosuquidar trihydrochloride IV over 6 hours on days 1-3 Patients also receive cytarabine IV continuously on days 1-7
Arm II Patients receive daunorubicin and cytarabine as in arm I Patients also receive placebo IV over 6 hours on days 1-3
Beginning on day 12 patients who achieve aplasia receive filgrastim G-CSF or sargramostim GM-CSF subcutaneously SC or IV daily until blood counts recover Patients who have evidence of persistent AML are eligible to receive a second identical course of induction chemotherapy
Consolidation I beginning within 8 weeks after documentation of complete remission CR or measurable remission MR Patients who achieve a CR or MR receive cytarabine IV over 1 hour once or twice daily on days 1-6 and GM-CSF or G-CSF SC or IV beginning on day 7 and continuing until blood counts recover
Consolidation II Patients who have maintained peripheral blood evidence of a remission receive daunorubicin cytarabine and zosuquidar trihydrochloride or placebo as in induction chemotherapy Patients also receive GM-CSF or G-CSF SC or IV beginning on day 8 or after last cytarabine dose and continuing until blood counts recover
Patients are followed monthly for 1 year every 2 months for 1 year every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL Approximately 450 patients 225 per treatment arm accrued over 41 years
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 |
|---|---|---|---|
| U10CA021115 | NIH | Eastern Cooperative Oncology Group | httpsreporternihgovquickSearchU10CA021115 |
| E3999 | OTHER | None | None |