Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136591
Status:
TERMINATED
Last Update Posted:
2010-10-26
First Post:
2005-08-26
Brief Title:
A Phase 2 Study of Velcade in Subjects With Relapsed or Refractory Follicular B-Cell Lymphoma
Sponsor:
Lymphoma Study Association
Organization:
Lymphoma Study Association
Study Overview
Official Title:
A Phase 2 Study of Velcade in Subjects With Relapsed or Refractory Follicular B-Cell Lymphoma
Status:
TERMINATED
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
An arm closed due to lack of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective randomized sequential international multicentric 2-arm non-comparative open-label 2-stage clinical study to determine disease response rates to Velcade therapy in subjects who have relapsed or refractory follicular B-cell lymphoma
Qualitative comparisons of the 2 treatment arms based on safety efficacy and dosing convenience will be made in order to recommend a dose schedule for further clinical study
Qualitative comparisons of the 2 treatment arms based on safety efficacy and dosing convenience will be made in order to recommend a dose schedule for further clinical study
Detailed Description:
This is a prospective randomized sequential international multicentric 2-arm non-comparative open-label 2-stage clinical study to determine disease response rates therapy of Velcade in subjects who have relapsed or refractory follicular B-cell lymphoma FLL
Qualitative comparisons of the 2 treatment arms based on safety efficacy and dosing convenience will be made in order to recommend a dose schedule for further clinical study
It is anticipated that approximatively 120 subjects will be enrolled to achieve the required 110 evaluable subjects 55 in each treatment arm Patients who receive any amount of Velcade are evaluable Subjects not evaluable for response will be replaced
A central randomization will be used in this study Subjects will be randomized and stratified with factors for prior therapies 1 or 2 versus 2 and time to progression TPP for the last given anti-neoplastic therapy 12 months versus 12 months
The eligible subjects will be randomized to either Treatment Arm A or Treatment Arm B in a 11 ratio
Subjects randomized to Treatment Arm A will receive 15 mgm² Velcade administered biweekly on Days 1 4 8 and 11 of a 21-day cycle Patients will receive 8 cycles The dose of Velcade received in schedule A will be 48 mgm² over 24 weeks
Subjects randomized to Treatment Arm B will receive 16 mgm² Velcade administered weekly on Days 1 8 15 and 22 of a 35-day cycle Patients will receive 6 cycles The dose of Velcade received in schedule B will be 384 mgm² over 30 weeks
Two additional cycles may be administered if the patient shows improvement to PR after 8 or 6 cycles for arm A or B respectively
Study drug dose and schedule reduction for toxicity will be allowed during the study
A two stage interim analysis will be conducted in each treatment arm to determine whether either of the 2 treatments lacks sufficient efficacy
The final analysis will be conducted when all subjects have had the opportunity to complete the 30 day post-treatment evaluation visit All data from all visits up until this point will be used in the final analysis including data from any follow-up visits that have occurred
Patients will be recruited approximately over 2 years and followed until all data are available for final analysis
The total duration of the study is expected to be 5 years
Qualitative comparisons of the 2 treatment arms based on safety efficacy and dosing convenience will be made in order to recommend a dose schedule for further clinical study
It is anticipated that approximatively 120 subjects will be enrolled to achieve the required 110 evaluable subjects 55 in each treatment arm Patients who receive any amount of Velcade are evaluable Subjects not evaluable for response will be replaced
A central randomization will be used in this study Subjects will be randomized and stratified with factors for prior therapies 1 or 2 versus 2 and time to progression TPP for the last given anti-neoplastic therapy 12 months versus 12 months
The eligible subjects will be randomized to either Treatment Arm A or Treatment Arm B in a 11 ratio
Subjects randomized to Treatment Arm A will receive 15 mgm² Velcade administered biweekly on Days 1 4 8 and 11 of a 21-day cycle Patients will receive 8 cycles The dose of Velcade received in schedule A will be 48 mgm² over 24 weeks
Subjects randomized to Treatment Arm B will receive 16 mgm² Velcade administered weekly on Days 1 8 15 and 22 of a 35-day cycle Patients will receive 6 cycles The dose of Velcade received in schedule B will be 384 mgm² over 30 weeks
Two additional cycles may be administered if the patient shows improvement to PR after 8 or 6 cycles for arm A or B respectively
Study drug dose and schedule reduction for toxicity will be allowed during the study
A two stage interim analysis will be conducted in each treatment arm to determine whether either of the 2 treatments lacks sufficient efficacy
The final analysis will be conducted when all subjects have had the opportunity to complete the 30 day post-treatment evaluation visit All data from all visits up until this point will be used in the final analysis including data from any follow-up visits that have occurred
Patients will be recruited approximately over 2 years and followed until all data are available for final analysis
The total duration of the study is expected to be 5 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 |
|---|---|---|---|
| Eudrac 2005-000734-21 | None | None | None |
| Janssen 28866138-LYM-2003 | None | None | None |