Study Of The Effectiveness & Safety Of Lenalidomide Versus Chlorambucil As First Line Therapy For Elderly Patients With B-Cell CLL (The ORIGIN Trial)

A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF LENALIDOMIDE (REVLIMID®) VERSUS CHLORAMBUCIL AS FIRST-LINE THERAPY FOR PREVIOUSLY UNTREATED ELDERLY PATIENTS WITH B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA (THE ORIGIN TRIAL) - THE ORIGIN TRIAL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-003079-32-GB

Enrollment

450

Registered

2009-05-29

Start date

2010-02-05

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

FIRST-LINE THERAPY FOR PREVIOUSLY UNTREATED ELDERLY PATIENTS WITH B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA MedDRA version: 20.0 Level: LLT Classification code 10009310 Term: CLL System Organ Class: 100000004864

Interventions

Trade Name: Leukeran Tablets 2 mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Chlorambucil CAS Number: 305-03-03 Concen

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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 - 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) -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)	—

Measure

Time frame

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 - 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) -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

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, France, Hungary, Italy, Netherlands, Portugal, Serbia, Slovakia, South Africa, Spain, United Kingdom, United States

Contacts

Public ContactClinicalTrialDisclosure

Celgene Corporation

ClinicalTrialDisclosure@celgene.com+1-888-260-1599

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026