Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006045
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
2000-07-05
Brief Title:
Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia
Sponsor:
Facet Biotech
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Randomized Multicenter Study to Assess the Efficacy and Safety of HuM195 Recombinant Humanized Anti-CD33 Monoclonal Antibody in Combination With Standardized Chemotherapy Compared to Standardized Chemotherapy Alone in the Treatment of Patients With Refractory or First-Relapsed Acute Myelogenous Leukemia AML
Status:
UNKNOWN
Status Verified Date:
2010-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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 tumor cells from dividing so they stop growing or die Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells It is not yet known if chemotherapy is more effective with or without monoclonal antibody therapy for acute myelogenous leukemia
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without monoclonal antibody therapy in treating patients who have refractory or relapsed acute myelogenous leukemia
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without monoclonal antibody therapy in treating patients who have refractory or relapsed acute myelogenous leukemia
Detailed Description:
OBJECTIVES I Compare the efficacy safety pharmacokinetics and immunogenicity of mitoxantrone etoposide and cytarabine MEC with or without monoclonal antibody HuG1-M195 in patients with refractory or relapsed acute myelogenous leukemia
OUTLINE This is a randomized multicenter study Patients are stratified by age under 50 vs 50 and over and duration of previous complete remission CR 0-6 vs 7-12 months All patients receive induction chemotherapy comprised of cytarabine IV over 2 hours mitoxantrone IV over a maximum of 20 minutes and etoposide IV over 1-2 hours on days 1-6 On day 5 of induction patients are randomized to one of two treatment arms Arm I Patients receive day 6 of induction chemotherapy Patients then receive monoclonal antibody HuG1-M195 MOAB HuM195 IV over 4 hours on days 6-9 or 7-10 Treatment with MOAB HuM195 repeats every 2 weeks for 2 courses courses 1 and 2 in the absence of disease progression or unacceptable toxicity During course 1 MOAB HuM195 begins 30 minutes to 24 hours postchemotherapy Patients who do not achieve CR by day 70 of induction and show evidence of bone marrow progression regimen failure RF are taken off study Patients without RF are assigned to one of two consolidation groups based on response Group A CR Patients receive consolidation chemotherapy comprised of mitoxantrone IV over a maximum of 20 minutes on days 1 and 2 and cytarabine IV over 2 hours and etoposide IV over 1-2 hours on days 1-4 Patients with New York Heart Association class II heart disease preconsolidation receive no mitoxantrone during consolidation Patients receive MOAB HuM195 IV over 4 hours on days 4-7 or 5-8 Treatment with MOAB HuM195 repeats every 2 weeks for 2 additional courses courses 3 and 4 During course 3 MOAB HuM195 begins 30 minutes to 24 hours postchemotherapy Group B partial remission PR hematologic improvement HI or stable disease SD Patients receive MOAB HuM195 as in group A but no consolidation chemotherapy Patients without RF after treatment on group A or B receive maintenance MOAB HuM195 IV over 4 hours on days 1-4 Treatment repeats every month for 8 additional courses courses 5-12 Arm II Patients receive day 6 of induction chemotherapy Patients receive no MOAB HuM195 during the entire study Patients without RF at day 70 of induction are assigned to one of two consolidation groups based on response Group C CR Patients receive consolidation chemotherapy as in group A Group D PR HI or SD Patients receive no further treatment Patients may be eligible to receive MOAB HuM195 on PDL Study 195-302 Patients are followed every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A maximum of 200 patients 100 per arm will be accrued for this study
OUTLINE This is a randomized multicenter study Patients are stratified by age under 50 vs 50 and over and duration of previous complete remission CR 0-6 vs 7-12 months All patients receive induction chemotherapy comprised of cytarabine IV over 2 hours mitoxantrone IV over a maximum of 20 minutes and etoposide IV over 1-2 hours on days 1-6 On day 5 of induction patients are randomized to one of two treatment arms Arm I Patients receive day 6 of induction chemotherapy Patients then receive monoclonal antibody HuG1-M195 MOAB HuM195 IV over 4 hours on days 6-9 or 7-10 Treatment with MOAB HuM195 repeats every 2 weeks for 2 courses courses 1 and 2 in the absence of disease progression or unacceptable toxicity During course 1 MOAB HuM195 begins 30 minutes to 24 hours postchemotherapy Patients who do not achieve CR by day 70 of induction and show evidence of bone marrow progression regimen failure RF are taken off study Patients without RF are assigned to one of two consolidation groups based on response Group A CR Patients receive consolidation chemotherapy comprised of mitoxantrone IV over a maximum of 20 minutes on days 1 and 2 and cytarabine IV over 2 hours and etoposide IV over 1-2 hours on days 1-4 Patients with New York Heart Association class II heart disease preconsolidation receive no mitoxantrone during consolidation Patients receive MOAB HuM195 IV over 4 hours on days 4-7 or 5-8 Treatment with MOAB HuM195 repeats every 2 weeks for 2 additional courses courses 3 and 4 During course 3 MOAB HuM195 begins 30 minutes to 24 hours postchemotherapy Group B partial remission PR hematologic improvement HI or stable disease SD Patients receive MOAB HuM195 as in group A but no consolidation chemotherapy Patients without RF after treatment on group A or B receive maintenance MOAB HuM195 IV over 4 hours on days 1-4 Treatment repeats every month for 8 additional courses courses 5-12 Arm II Patients receive day 6 of induction chemotherapy Patients receive no MOAB HuM195 during the entire study Patients without RF at day 70 of induction are assigned to one of two consolidation groups based on response Group C CR Patients receive consolidation chemotherapy as in group A Group D PR HI or SD Patients receive no further treatment Patients may be eligible to receive MOAB HuM195 on PDL Study 195-302 Patients are followed every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A maximum of 200 patients 100 per arm will be accrued for this study
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 |
|---|---|---|---|
| NCI-G00-1819 | None | None | None |
| PDL-195-301 | None | None | None |
| MSKCC-00029 | None | None | None |
| UCLA-9910050 | None | None | None |