Ignite Creation Date:
2024-05-06 @ 12:08 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01496976
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2011-12-16
Brief Title:
Ofatumumab High Dose Methylprednisolone Ofatumumab and Lenalidomide Consolidative Therapy for Untreated CLLSLL
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase II Study of Ofatumumab in Combination With High Dose Methylprednisolone Followed by Ofatumumab and Lenalidomide Consolidative Therapy for the Treatment of Untreated CLLSLL The HiLOG Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
The main purpose of this study is to see if ofatumumab with methylprednisolone followed by additional treatment with ofatumumab and lenalidomide can help people with Chronic Lymphocytic Leukemia CLL get rid of their CLL for a long period of time Researchers also want to find out if the combination of ofatumumab with methylprednisolone followed by additional treatment with ofatumumab and lenalidomide is safe and tolerable
Detailed Description:
This is a phase II single institution and non-randomized study of patients with untreated CLLSLL utilizing a two-stage trial design The primary endpoint for this trial is the combined complete and partial response rate at 3 months-the end of cycle 3 to the protocol therapy We anticipate this trial will have a complete response CR and partial response PR rate of at least 80
A two-stage design is employed for this trial The nullunacceptable CRPR response rate is 60 while the anticipated true response rate to the protocol treatment is at least 80 for each disease cohort At the first stage 26 patients will be accrued to the trial If 15 or fewer of these patients respond then the trial will be terminated early and the response rate to the protocol treatment will be deemed unacceptable 60 Otherwise if more than 15 patients respond during the first stage an additional 19 patients will be enrolled to this trial during stage 2 for a total of 45 patients If 32 or fewer of these 45 patients respond to the protocol treatment at the end of stage 2 no further investigation of the protocol treatment is considered warranted On the other hand if more than 32 patients out of the 45 enrolled patients respond the protocol treatment will be considered promising If the true response rate is 60 the probability of ending the trial at stage 1 is 048 If however the true response rate is at least 80 then the probability of ending the trial at stage 1 is only 001 This two-stage design has an overall alpha level of 0045 and a power of 090
A two-stage design is employed for this trial The nullunacceptable CRPR response rate is 60 while the anticipated true response rate to the protocol treatment is at least 80 for each disease cohort At the first stage 26 patients will be accrued to the trial If 15 or fewer of these patients respond then the trial will be terminated early and the response rate to the protocol treatment will be deemed unacceptable 60 Otherwise if more than 15 patients respond during the first stage an additional 19 patients will be enrolled to this trial during stage 2 for a total of 45 patients If 32 or fewer of these 45 patients respond to the protocol treatment at the end of stage 2 no further investigation of the protocol treatment is considered warranted On the other hand if more than 32 patients out of the 45 enrolled patients respond the protocol treatment will be considered promising If the true response rate is 60 the probability of ending the trial at stage 1 is 048 If however the true response rate is at least 80 then the probability of ending the trial at stage 1 is only 001 This two-stage design has an overall alpha level of 0045 and a power of 090
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RV-CLL-PI-0560 | OTHER_GRANT | Celgene Corp | None |
| COMB157BUS21T | OTHER_GRANT | None | None |