Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016159
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2001-05-06
Brief Title:
Chemotherapy Plus Monoclonal Antibody in Treating Patients With Acute Promyelocytic Leukemia
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Study Of Combined Modality Postremission Therapy As Determined By Molecular Response Adaptive Regulation In The Treatment Of Acute Promyelocytic Leukemia APL
Status:
COMPLETED
Status Verified Date:
2013-01
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 can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy and monoclonal antibody in treating patients who have acute promyelocytic leukemia
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy and monoclonal antibody in treating patients who have acute promyelocytic leukemia
Detailed Description:
OBJECTIVES
Determine the disease-free and overall survival of patients with acute promyelocytic leukemia in clinical complete remission following tretinoin-based induction therapy treated with monoclonal antibody HuG1-M195 arsenic trioxide idarubicin and tretinoin
Determine the rate of molecular complete remission in patients treated with this regimen
Determine the toxicity of this regimen in this patient population
Determine the number and length of hospitalizations of patients treated with this regimen
OUTLINE Patients receive monoclonal antibody HuG1-M195 MOAB HuM195 IV over 40-60 minutes twice weekly for 3 weeks Approximately 2-4 weeks after completion of MOAB HuM195 patients receive arsenic trioxide IV over 1-4 hours daily for a total of 25 days with no more than 5 days between doses
Beginning approximately 4-6 weeks after completion of arsenic trioxide patients receive idarubicin IV daily on days 1-3 or 1-4 and filgrastim G-CSF subcutaneously daily beginning on day 5 or 6 and continuing until blood counts recover Treatment repeats every 4 weeks for patients who remain RT-PCR positive or are newly converted to RT-PCR negative molecular complete remission following a prior course of idarubicin for a maximum of 3 courses Patients who remain RT-PCR positive following course 3 of idarubicin receive no further treatment on study
Beginning 3 months after completion of idarubicin patients in molecular complete remission receive oral tretinoin daily for 14 days Treatment repeats every 3 months for a total of 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed monthly
PROJECTED ACCRUAL Approximately 35 patients will be accrued for this study within 2-3 years
Determine the disease-free and overall survival of patients with acute promyelocytic leukemia in clinical complete remission following tretinoin-based induction therapy treated with monoclonal antibody HuG1-M195 arsenic trioxide idarubicin and tretinoin
Determine the rate of molecular complete remission in patients treated with this regimen
Determine the toxicity of this regimen in this patient population
Determine the number and length of hospitalizations of patients treated with this regimen
OUTLINE Patients receive monoclonal antibody HuG1-M195 MOAB HuM195 IV over 40-60 minutes twice weekly for 3 weeks Approximately 2-4 weeks after completion of MOAB HuM195 patients receive arsenic trioxide IV over 1-4 hours daily for a total of 25 days with no more than 5 days between doses
Beginning approximately 4-6 weeks after completion of arsenic trioxide patients receive idarubicin IV daily on days 1-3 or 1-4 and filgrastim G-CSF subcutaneously daily beginning on day 5 or 6 and continuing until blood counts recover Treatment repeats every 4 weeks for patients who remain RT-PCR positive or are newly converted to RT-PCR negative molecular complete remission following a prior course of idarubicin for a maximum of 3 courses Patients who remain RT-PCR positive following course 3 of idarubicin receive no further treatment on study
Beginning 3 months after completion of idarubicin patients in molecular complete remission receive oral tretinoin daily for 14 days Treatment repeats every 3 months for a total of 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed monthly
PROJECTED ACCRUAL Approximately 35 patients will be accrued for this study within 2-3 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-H01-0073 | None | None | None |
| MSKCC-00072 | None | None | None |