Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005962
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2000-07-05
Brief Title:
Comparison of Three Treatment Regimens in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase II Randomized Trial of Immunologic and Chemotherapeutic Agents for Treatment of Patients With Relapsed or Refractory Acute Myelogenous Leukemia
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 Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Combining more than one drug or combining monoclonal antibody with chemotherapy may kill more cancer cells It is not yet known which treatment regimen is more effective for acute myelogenous leukemia
PURPOSE Randomized phase II trial to compare the effectiveness of three treatment regimens in treating patients who have relapsed or refractory acute myelogenous leukemia
PURPOSE Randomized phase II trial to compare the effectiveness of three treatment regimens in treating patients who have relapsed or refractory acute myelogenous leukemia
Detailed Description:
OBJECTIVES
Compare the rates of complete response CR and CR without full platelet recovery in patients with relapsed or refractory acute myelogenous leukemia treated with gemtuzumab ozogamicin and cytarabine vs daunorubicin liposomal and cytarabine vs cyclophosphamide cytarabine and topotecan
Compare the toxicities of these 3 regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified by disease status relapse less than 6 months after first complete response CR vs relapse 6-12 months after first CR vs refractory to conventional initial induction chemotherapy no more than 2 courses or first reinduction no more than 1 course vs second or greater relapse
Induction Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive cytarabine IV over 2 hours on days 1-4 and gemtuzumab ozogamicin IV over 2 hours on day 5
Arm II Patients receive daunorubicin liposomal IV over a minimum of 2 hours on days 1-3 and cytarabine IV over 2 hours beginning immediately after completion of daunorubicin liposomal infusion on days 1-4
Arm III Patients receive cyclophosphamide IV over 1 hour every 12 hours on days 1-3 cytarabine IV over 2 hours beginning immediately after completion of cyclophosphamide infusion on days 2-6 and topotecan IV continuously on days 2-6
Consolidation Patients who achieve complete remission CR receive 1 additional course of induction therapy on the same arm to which they were originally randomized beginning within 4-6 weeks after initial documentation of CR Patients on arm II receive no additional daunorubicin liposomal if resting ejection fraction is less than 50 preconsolidation All patients receive sargramostim GM-CSF IV over 4 hours or SQ daily beginning 24 hours after completion of consolidation therapy and continuing until blood counts recover
Patients are followed every 3 months through year 2 every 6 months through year 5 and then annually thereafter until death
PROJECTED ACCRUAL A maximum of 150-165 patients 50-55 per arm will be accrued for this study within 2 years
Compare the rates of complete response CR and CR without full platelet recovery in patients with relapsed or refractory acute myelogenous leukemia treated with gemtuzumab ozogamicin and cytarabine vs daunorubicin liposomal and cytarabine vs cyclophosphamide cytarabine and topotecan
Compare the toxicities of these 3 regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified by disease status relapse less than 6 months after first complete response CR vs relapse 6-12 months after first CR vs refractory to conventional initial induction chemotherapy no more than 2 courses or first reinduction no more than 1 course vs second or greater relapse
Induction Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive cytarabine IV over 2 hours on days 1-4 and gemtuzumab ozogamicin IV over 2 hours on day 5
Arm II Patients receive daunorubicin liposomal IV over a minimum of 2 hours on days 1-3 and cytarabine IV over 2 hours beginning immediately after completion of daunorubicin liposomal infusion on days 1-4
Arm III Patients receive cyclophosphamide IV over 1 hour every 12 hours on days 1-3 cytarabine IV over 2 hours beginning immediately after completion of cyclophosphamide infusion on days 2-6 and topotecan IV continuously on days 2-6
Consolidation Patients who achieve complete remission CR receive 1 additional course of induction therapy on the same arm to which they were originally randomized beginning within 4-6 weeks after initial documentation of CR Patients on arm II receive no additional daunorubicin liposomal if resting ejection fraction is less than 50 preconsolidation All patients receive sargramostim GM-CSF IV over 4 hours or SQ daily beginning 24 hours after completion of consolidation therapy and continuing until blood counts recover
Patients are followed every 3 months through year 2 every 6 months through year 5 and then annually thereafter until death
PROJECTED ACCRUAL A maximum of 150-165 patients 50-55 per arm will be accrued for this study within 2 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 |
|---|---|---|---|
| E-4999 | None | None | None |