Ignite Creation Date:
2024-05-06 @ 8:58 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02863718
Status:
COMPLETED
Last Update Posted:
2022-11-07
First Post:
2014-06-10
Brief Title:
Ibrutinib in Previously Untreated Binet Stage A Chronic Lymphocytic Leukemia With Risk of Disease Progression
Sponsor:
German CLL Study Group
Organization:
German CLL Study Group
Study Overview
Official Title:
A Placebo-Controlled Double-Blind Randomized Multicenter Three Arm Phase III Trial to Compare the Efficacy and Safety of Ibrutinib vs Placebo in Previously Untreated Binet Stage A Chronic Lymphocytic Leukemia Patients With Risk of Early Disease Progression
Status:
COMPLETED
Status Verified Date:
2022-11
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:
CLL12
Brief Summary:
This is a prospective multicenter randomized placebo-controlled double-blind phase III study that compares the efficacy and safety of oral ibrutinib in previously untreated Binet stage A CLL patients without treatment indication according to iwCLL guidelines but risk of early disease progression
For event-free survival EFS an improvement from 24 months for untreated intermediate or very high risk CLL to 48 months for subjects treated with ibrutinib is considered clinically relevant Ibrutinib placebo is administered continuously orally until symptomatic disease progression unacceptable toxicity or voluntary treatment withdrawal whichever occurs first
For event-free survival EFS an improvement from 24 months for untreated intermediate or very high risk CLL to 48 months for subjects treated with ibrutinib is considered clinically relevant Ibrutinib placebo is administered continuously orally until symptomatic disease progression unacceptable toxicity or voluntary treatment withdrawal whichever occurs first
Detailed Description:
The primary objective of the study is to demonstrate superiority of ibrutinib over placebo in prolonging EFS for subjects with treatment-naïve CLL stage A and intermediate or very high risk of disease progression All subjects with intermediate very high risk randomized to the experimental treatment arm will be treated up to active progressive disease with treatment indication according to iwCLL-Guidelines with the objective to demonstrate prolongation of EFS for the ibrutinib arm EFS is defined as the time between randomization until active progressive disease with treatment indication according to the iwCLL-Guidelines with subsequent treatment for CLL or death
The secondary objectives are
To evaluate the prolongation of overall survival of ibrutinib versus placebo
To evaluate the safety of ibrutinib versus placebo
The secondary objectives are
To evaluate the prolongation of overall survival of ibrutinib versus placebo
To evaluate the safety of ibrutinib versus placebo
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 |
|---|---|---|---|
| 2013-003211-22 | EUDRACT_NUMBER | None | None |