Study Of The Effectiveness & Safety Of Lenalidomide VersusChlorambucil As First Line Therapy For Elderly Patients With B-Cell CLL(The ORIGIN Trial)
Phase 1
- Conditions
- FIRST-LINE THERAPY FOR PREVIOUSLY UNTREATED ELDERLY PATIENTS WITH B-CELL CHRONIC LYMPHOCYTIC LEUKEMIAMedDRA version: 16.1Level: LLTClassification code 10009310Term: CLLSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2008-003079-32-BE
- Lead Sponsor
- Celgene Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
Inclusion Criteria
The study population consists of patients who were randomized under previous amendments and were ongoing during Amendment 6, Version dated 08 May 2013.
Enrollment was closed as of 20 February 2013, with last patient randomized 28 March 2013.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 450
Exclusion Criteria
The study population consists of patients who were randomized under previous amendments and were ongoing during Amendment 6, Version dated 08 May 2013.
Enrollment was closed as of 20 February 2013, with last patient randomized 28 March 2013.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - To continue to provide chlorambucil to subjects randomized to the chlorambucil arm and aged = 65 and < 81 years of age up to 13 cycles (approximately 12 months), at the discretion of the Investigator<br>- To compare the long term safety of lenalidomide versus chlorambucil in elderly CLL patients ;Secondary Objective: Not applicable;Primary end point(s): -Safety (type, frequency, and severity of adverse events (AEs) and relationship to study drug)<br>-During the survival follow-up, SPMs, OS, and other anti-cancer CLL therapies will be obtained for all randomized patients ;Timepoint(s) of evaluation of this end point: Regularly on patients' follow-up visits (every 4 months)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable