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

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2008-003079-32-BG
• Date of registration: 28/04/2010
• Prospective Registration: Yes
• Primary sponsor: Celgene Corporation
• Public title: Study Of The Effectiveness & Safety Of Lenalidomide Versus Chlorambucil As First Line Therapy For Elderly Patients With B-Cell CLL (The ORIGIN Trial)
• Scientific title: 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
• Date of first enrolment: 21/05/2010
• Target sample size: 450
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-003079-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

• Name: ClinicalTrialDisclosure
• Affiliation: Celgene Corporation

• Name: ClinicalTrialDisclosure
• Affiliation: Celgene Corporation

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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: 100000012990

Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Intervention(s)

Trade Name: Leukeran Tablets 2 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Chlorambucil
CAS Number: 305-03-03
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-

Primary Outcome(s)

Main Objective: To compare the efficacy of lenalidomide versus chlorambucil as first-line therapy in elderly patients

Secondary Objective: N/A

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 Outcome(s)

Timepoint(s) of evaluation of this end point: N/A

Secondary end point(s): N/A

Secondary ID(s)

2008-003079-32-ES

CC-5013-CLL-008

Source(s) of Monetary Support

Celgene Corporation

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 25/05/2019
• Date Completed: 09/05/2018
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2008-003079-32/results