Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112983
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2005-06-02
Brief Title:
Eculizumab in Treating Patients With Paroxysmal Nocturnal Hemoglobinuria
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
TRIUMPH A Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation Randomized Multi-Center Double-Blind Placebo-Controlled Using Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients
Status:
COMPLETED
Status Verified Date:
2005-06
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 Chemoprevention is the use of certain drugs to keep cancer from forming growing or coming back The use of eculizumab may prevent leukemia and stop the destruction of red blood cells in patients with paroxysmal nocturnal hemoglobinuria
PURPOSE This randomized phase III trial is studying how well eculizumab works in treating patients with paroxysmal nocturnal hemoglobinuria
PURPOSE This randomized phase III trial is studying how well eculizumab works in treating patients with paroxysmal nocturnal hemoglobinuria
Detailed Description:
OBJECTIVES
Primary
Determine the safety of eculizumab in patients with transfusion-dependent hemolytic paroxysmal nocturnal hemoglobinuria
Determine the efficacy of this drug in terms of hemoglobin stabilization and the number of packed red blood cell units transfused during the 26-week treatment period in these patients
Secondary
Compare the occurrence of transfusion avoidance hemolysis measured by lactate dehydrogenase LDH area under the curve and the changes in fatigue during the 26-week treatment period in patients treated with this drug vs placebo
Compare LDH changes quality of life changes thrombosis platelet activity nitric oxide and free hemoglobin measures during the 26-week treatment period in patients treated with these regimens
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to the number of packed red blood cell PRBC units transfused 1 year prior to screening 15 units vs 15-25 units vs 25 units Patients are randomized to 1 of 2 treatment arms
Arm I Within 10 days after PRBC transfusion administered during the study observation period patients receive placebo IV over 30 minutes once a week for 5 weeks and then once every 2 weeks for 21 weeks
Arm II Within 10 days after PRBC transfusion administered during the study observation period patients receive eculizumab IV over 30 minutes once a week for 5 weeks and then once every 2 weeks for 21 weeks
Quality of life is assessed at baseline at weeks 0-4 12 20 and 26 during study treatment then at weeks 1 2 4 and 8 after completion of study treatment
After completion of study treatment patients are followed at weeks 1 2 4 and 8
PROJECTED ACCRUAL Approximately 75 patients 37 per treatment arm will be accrued for this study
Primary
Determine the safety of eculizumab in patients with transfusion-dependent hemolytic paroxysmal nocturnal hemoglobinuria
Determine the efficacy of this drug in terms of hemoglobin stabilization and the number of packed red blood cell units transfused during the 26-week treatment period in these patients
Secondary
Compare the occurrence of transfusion avoidance hemolysis measured by lactate dehydrogenase LDH area under the curve and the changes in fatigue during the 26-week treatment period in patients treated with this drug vs placebo
Compare LDH changes quality of life changes thrombosis platelet activity nitric oxide and free hemoglobin measures during the 26-week treatment period in patients treated with these regimens
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to the number of packed red blood cell PRBC units transfused 1 year prior to screening 15 units vs 15-25 units vs 25 units Patients are randomized to 1 of 2 treatment arms
Arm I Within 10 days after PRBC transfusion administered during the study observation period patients receive placebo IV over 30 minutes once a week for 5 weeks and then once every 2 weeks for 21 weeks
Arm II Within 10 days after PRBC transfusion administered during the study observation period patients receive eculizumab IV over 30 minutes once a week for 5 weeks and then once every 2 weeks for 21 weeks
Quality of life is assessed at baseline at weeks 0-4 12 20 and 26 during study treatment then at weeks 1 2 4 and 8 after completion of study treatment
After completion of study treatment patients are followed at weeks 1 2 4 and 8
PROJECTED ACCRUAL Approximately 75 patients 37 per treatment arm will be accrued for this study
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 |
|---|---|---|---|
| UCLA-0406101-01 | None | None | None |
| CDR0000409569 | REGISTRY | PDQ Physician Data Query | None |