Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00486421
Status:
COMPLETED
Last Update Posted:
2014-10-17
First Post:
2007-06-13
Brief Title:
Rituximab and Prednisone as First-Line Therapy in Treating Patients With Immune Thrombocytopenic Purpura
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Pilot Study of Rituximab in Combination With Corticosteroids for the Initial Treatment of Immune Thrombocytopenic Purpura
Status:
COMPLETED
Status Verified Date:
2014-10
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 Rituximab and prednisone may increase the number of platelets in patients with immune thrombocytopenic purpura
PURPOSE This phase II trial is studying the side effects and how well giving rituximab together with prednisone works as first-line therapy in treating patients with immune thrombocytopenic purpura
PURPOSE This phase II trial is studying the side effects and how well giving rituximab together with prednisone works as first-line therapy in treating patients with immune thrombocytopenic purpura
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of rituximab when administered with standard prednisone treatment in maintaining a platelet count 50000mm³ at 6 months without further therapies eg splenectomy or other salvage therapies in patients with immune thrombocytopenic purpura
Determine the safety of this regimen in these patients
Secondary
Determine the time to platelet recovery in patients treated with this regimen
Determine the duration of platelet recovery in patients treated with this regimen
Assess efficacy of this regimen in preventing spontaneous bleeding events in these patients
Determine the response in patients treated with this regimen
OUTLINE This is a pilot study
Patients receive rituximab IV on days 1 8 15 and 22 and oral prednisone once daily on days 1-14 followed by a taper to day 56 Treatment is administered in the absence of disease relapse or unacceptable toxicity
After completion of study therapy patients are followed periodically for up to 3 years
Primary
Determine the efficacy of rituximab when administered with standard prednisone treatment in maintaining a platelet count 50000mm³ at 6 months without further therapies eg splenectomy or other salvage therapies in patients with immune thrombocytopenic purpura
Determine the safety of this regimen in these patients
Secondary
Determine the time to platelet recovery in patients treated with this regimen
Determine the duration of platelet recovery in patients treated with this regimen
Assess efficacy of this regimen in preventing spontaneous bleeding events in these patients
Determine the response in patients treated with this regimen
OUTLINE This is a pilot study
Patients receive rituximab IV on days 1 8 15 and 22 and oral prednisone once daily on days 1-14 followed by a taper to day 56 Treatment is administered in the absence of disease relapse or unacceptable toxicity
After completion of study therapy patients are followed periodically for up to 3 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 |
|---|---|---|---|
| U2985s | OTHER | Genentech protocol | httpsreporternihgovquickSearchP30CA015083 |
| P30CA015083 | NIH | None | None |
| MC0481 | OTHER | None | None |
| 2071-04 | OTHER | None | None |