Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003991
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
1999-11-01
Brief Title:
Interleukin-2 Plus Histamine Dihydrochloride in Treating Patients With Acute Myeloid Leukemia
Sponsor:
Maxim Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Multi-Center Randomized Open-Label Study to Evaluate the Safety and Efficacy of Immunotherapy With Subcutaneous Maxamine Histamine Dihydrochloride Plus Proleukin Interleukin-2 Versus No Treatment Standard of Care in Patients With Acute Myeloid Leukemia in First or Subsequent Complete Remission CR
Status:
COMPLETED
Status Verified Date:
2011-12
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 Interleukin-2 may stimulate a persons white blood cells to kill acute myeloid leukemia cells Histamine dihydrochloride may prolong remission and reduce the risk of relapse in patients with acute myeloid leukemia in remission
PURPOSE Randomized phase III trial to determine the effectiveness of interleukin-2 plus histamine dihydrochloride in treating patients who have acute myeloid leukemia that is in remission following previous therapy
PURPOSE Randomized phase III trial to determine the effectiveness of interleukin-2 plus histamine dihydrochloride in treating patients who have acute myeloid leukemia that is in remission following previous therapy
Detailed Description:
OBJECTIVES I Compare the efficacy of interleukin-2 plus histamine dihydrochloride Maxamine vs no further therapy in prolonging the leukemia free survival in patients with acute myeloid leukemia in first or subsequent complete remission CR following consolidation therapy II Compare the relapse rate overall survival and quality of life in this patient population treated with interleukin-2 plus Maxamine vs no further therapy III Compare the remission inversion rate in patients in subsequent CR with this treatment regimen vs no further therapy
OUTLINE This is a randomized open label parallel multicenter study Patients are stratified according to complete remission first vs subsequent Patients are randomized to one of two treatment arms Arm I Following consolidation chemotherapy or autologous stem cell transplantation patients receive interleukin-2 subcutaneously followed by histamine dihydrochloride subcutaneously over 5-7 minutes twice daily on days 1-21 Treatment repeats every 6 weeks for 3 courses and then every 9 weeks for 7 courses in the absence of disease relapse or unacceptable toxicity Arm II Patients receive no further therapy following consolidation chemotherapy or autologous stem cell transplantation Quality of life is assessed prior to study and at visits 6 7 10 11 16 17 and 22 Patients are followed for relapse and survival every 3 months for 25 years
PROJECTED ACCRUAL A total of 360 patients will be accrued for this study
OUTLINE This is a randomized open label parallel multicenter study Patients are stratified according to complete remission first vs subsequent Patients are randomized to one of two treatment arms Arm I Following consolidation chemotherapy or autologous stem cell transplantation patients receive interleukin-2 subcutaneously followed by histamine dihydrochloride subcutaneously over 5-7 minutes twice daily on days 1-21 Treatment repeats every 6 weeks for 3 courses and then every 9 weeks for 7 courses in the absence of disease relapse or unacceptable toxicity Arm II Patients receive no further therapy following consolidation chemotherapy or autologous stem cell transplantation Quality of life is assessed prior to study and at visits 6 7 10 11 16 17 and 22 Patients are followed for relapse and survival every 3 months for 25 years
PROJECTED ACCRUAL A total of 360 patients 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 |
|---|---|---|---|
| CWRU-MAXI-1998 | None | None | None |
| MAXIM-MP-MA-0201 | None | None | None |