Study Of The Effectiveness & Safety Of Lenalidomide Versus Chlorambucil 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: 20.0 Level: LLT Classification code 10009310 Term: CLL System Organ Class: 100000004864Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2008-003079-32-GB
- Lead Sponsor
- Celgene Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- 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
- Secondary Outcome Measures
Name Time Method