Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070291
Status:
TERMINATED
Last Update Posted:
2023-06-29
First Post:
2003-10-03
Brief Title:
Cyclosporine in Treating Patients With Recurrent or Refractory Angioimmunoblastic T-Cell Lymphoma
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase II Study of Cyclosporine in the Treatment of Angioimmunoblastic T-Cell Lymphoma
Status:
TERMINATED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Cyclosporine may help the immune system slow the growth of angioimmunoblastic T-cell lymphoma
PURPOSE This phase II trial is studying how well cyclosporine works in treating patients with recurrent or refractory angioimmunoblastic T-cell lymphoma
PURPOSE This phase II trial is studying how well cyclosporine works in treating patients with recurrent or refractory angioimmunoblastic T-cell lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the response rate complete and partial in patients with recurrent or refractory angioimmunoblastic T-cell lymphoma treated with cyclosporine
Secondary
Determine the disease-free progression-free and overall survival of patients treated with this drug
Determine the toxicity of this drug in these patients
OUTLINE Patients receive oral cyclosporine twice daily for up to 36 weeks in the absence of unacceptable toxicity or disease progression during weeks 1-6 Patients experiencing disease progression during weeks 7-36 receive an additional 36 weeks of therapy
Patients are followed every 3 months for 2 years and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 27 patients will be accrued for this study within 25 years
Primary
Determine the response rate complete and partial in patients with recurrent or refractory angioimmunoblastic T-cell lymphoma treated with cyclosporine
Secondary
Determine the disease-free progression-free and overall survival of patients treated with this drug
Determine the toxicity of this drug in these patients
OUTLINE Patients receive oral cyclosporine twice daily for up to 36 weeks in the absence of unacceptable toxicity or disease progression during weeks 1-6 Patients experiencing disease progression during weeks 7-36 receive an additional 36 weeks of therapy
Patients are followed every 3 months for 2 years and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 27 patients will be accrued for this study within 25 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 |
|---|---|---|---|
| U10CA021115 | NIH | None | None |
| E2402 | OTHER | Eastern Cooperative Oncology Group ECOG | httpsreporternihgovquickSearchU10CA021115 |