Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005074
Status:
COMPLETED
Last Update Posted:
2020-04-09
First Post:
2000-04-06
Brief Title:
Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase II Study of Flavopiridol HMR 1275 NSC 649890 in Patients With Untreated or Relapsed Mantle Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2020-04
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
PURPOSE Phase II trial to study the effectiveness of flavopiridol in treating patients who have previously untreated or relapsed mantle cell lymphoma
PURPOSE Phase II trial to study the effectiveness of flavopiridol in treating patients who have previously untreated or relapsed mantle cell lymphoma
Detailed Description:
OBJECTIVES
Assess the efficacy of flavopiridol in terms of response rate in patients with previously untreated or relapsed mantle cell lymphoma
Assess the toxicity of this regimen in this patient population
Determine the time to progression and if responses are observed response duration in these patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive flavopiridol IV over 1 hour daily for 3 days Treatment continues every 3 weeks in the absence of unacceptable toxicity or disease progression Patients with a complete response CR receive 2 additional courses after documented CR Patients with a partial response receive 2 additional courses after documented maximal tumor shrinkage Patients with stable disease receive a maximum of 4 courses
Patients are followed at 4 weeks and then every 3 months until relapse or death
PROJECTED ACCRUAL A total of 14-30 patients will be accrued for this study within 18-24 months
Assess the efficacy of flavopiridol in terms of response rate in patients with previously untreated or relapsed mantle cell lymphoma
Assess the toxicity of this regimen in this patient population
Determine the time to progression and if responses are observed response duration in these patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive flavopiridol IV over 1 hour daily for 3 days Treatment continues every 3 weeks in the absence of unacceptable toxicity or disease progression Patients with a complete response CR receive 2 additional courses after documented CR Patients with a partial response receive 2 additional courses after documented maximal tumor shrinkage Patients with stable disease receive a maximum of 4 courses
Patients are followed at 4 weeks and then every 3 months until relapse or death
PROJECTED ACCRUAL A total of 14-30 patients will be accrued for this study within 18-24 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000067679 | OTHER | PDQ | None |
| CAN-NCIC-IND127 | OTHER | None | None |
| NCI-100 | OTHER | None | None |