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 TRIA
- Conditions
- FIRST-LINE THERAPY FOR PREVIOUSLY UNTREATED ELDERLY PATIENTS WITH B-CELL CHRONIC LYMPHOCYTIC LEUKEMIAMedDRA version: 9.1Level: LLTClassification code 10009310Term: C
- Registration Number
- EUCTR2008-003079-32-FR
- Lead Sponsor
- Celgene Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 428
1.Must understand and voluntarily sign an informed consent form.
2.Age = 65 years at the time of signing the informed consent form.
3.Must be able to adhere to the study visit schedule and other protocol requirements.
4.Must have a documented diagnosis of B-cell CLL [IWCLL guidelines for diagnosis and treatment of CLL ] meeting at least one of the following criteria:
•Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia
•Massive (i.e. > 6 cm below the left costal margin) or progressive or symptomatic splenomegaly
•Massive nodes (i.e. > 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy
•Progressive lymphocytosis with an increase of > 50% over a 2 month period, or lymphocyte doubling time (LDT) of less than 6 months
•A minimum of any one of the following disease-related symptoms must be present:
Unintentional weight loss = 10% within the previous 6 months
Significant fatigue (i.e., ECOG PS 2; cannot work or unable to perform usual activities)
Fevers of greater than 100.5° F or 38.0° C for 2 or more weeks without other evidence of infection
Night sweats for more than 1 month without evidence of infection
5.Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of =2.
6.Females of childbearing potential (FCBP) must:
•Have a negative medically supervised pregnancy test prior to starting of study therapy and agree to ongoing pregnancy testing during the course of the study and after end of study therapy. This applies even if the patient practices complete and continued sexual abstinence.
•Either commit to continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy.
7.Male patients must:
•Agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy.
•Agree not to donate semen during study drug therapy and for a period after end of study drug therapy.
8.All patients must:
•Have an understanding that the study drug could have a potential teratogenic risk.
•Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy.
•Agree not to share study drug with another person.
•All patients must be counseled about pregnancy precautions and risks of fetal exposure: Education and Counseling Guidance Document.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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
1.Prior treatment for B-cell CLL.
2.Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form.
3.Active infections requiring systemic antibiotics.
4.Systemic infection that has not resolved > 2 months prior to initiating study treatment in spite of adequate anti-infective therapy
5.Pregnant or lactating females.
6.Participation in any clinical study or having taken any investigational therapy within 28 days prior to initiating study therapy.
7.Known presence of alcohol and/or drug abuse.
8.Central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging. Patients who have signs or symptoms suggestive of leukemic meningitis or a history of leukemic meningitis must have a lumbar puncture procedure performed within two weeks prior to randomization.
9.Prior history of malignancies, other than CLL, unless the patient has been free of the disease for =3 years. Exceptions include the following:
•Basal cell carcinoma of the skin
•Squamous cell carcinoma of the skin
•Carcinoma in situ of the cervix
•Carcinoma in situ of the breast
•Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
10.History of renal failure requiring dialysis.
11.Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection.
12.Prior therapy with lenalidomide.
13.Evidence of TLS per the Cairo-Bishop definition of laboratory TLS (patients may be enrolled upon correction of electrolyte abnormalities).
14.Any of the following laboratory abnormalities:
•Calculated (method of Cockroft-Gault) creatinine clearance of <30 mL/min
•Absolute neutrophil count (ANC) < 1,000/µL (1.0 X 109/L)
•Platelet count < 50,000/µL (50 X 109/L)
•Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) > 5 x upper limit of normal (ULN)
•Serum total bilirubin > 1.5 x ULN, except in cases of Gilbert’s syndrome.
15.Uncontrolled hyperthyroidism or hypothyroidism
16.Venous thromboembolism within one year
17.= Grade 2 neuropathy
18.Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
19.Disease transformation [i.e. Richter’s Syndrome (lymphomas) or prolymphocytic leukemia]
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Progression Free Survival (PFS);Main Objective: To compare the efficacy of lenalidomide versus chlorambucil as first-line therapy in elderly patients ;Secondary Objective: To evaluate the safety of lenalidomide versus chlorambucil as first-line therapy in elderly patients
- Secondary Outcome Measures
Name Time Method