CLL Lenalidomide Maintanence 002 - The Continuum Trial
A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF LENALIDOMIDE (REVLIMID®) AS MAINTENANCE THERAPY FOR PATIENTS WITH B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA FOLLOWING SECOND-LINE THERAPY (The Continuum Trial)
1. Must understand and voluntarily sign an informed consent form.
2. Age ≥ 18 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
5. Must have been treated with a purine analog-containing regimen in the first and/or second line induction therapy.
6. Must have achieved a minimum response of partial response (PR, CRi, CR and MRD-negative CR) following completion of second-line induction therapy prior to randomization. Second-line induction therapy must be documented to have been of sufficient duration (e.g. 3 cycles of treatment, 6 weeks of alemtuzumab given intravenously or 8 weeks of alemtuzumab given subcutaneously, etc.).
7. Must have completed last cycle of second-line induction no less than 8 weeks (56 days) and no greater than 16 weeks (112 days) prior to randomization.
8. Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2.
9. Females of childbearing potential must:
Have a negative medically supervised pregnancy test prior to starting of study therapy, agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject 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.
10. Male subjects must:
Agree to use a condom during sexual contact, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy.
Agree to not donate semen during study drug therapy and for a period after end of study drug therapy.
11. All subjects 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 medication with another person.
All subjects must be counseled about pregnancy precautions and risks of fetal exposure.
1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
2. Active infections requiring systemic antibiotics.
3. Systemic infection that has not resolved > 2 months prior to initiating lenalidomide treatment in spite of adequate anti-infective therapy
4. Autologous or allogeneic bone marrow transplant as second line therapy.
5. Pregnant or lactating females.
6. Systemic treatment for B-cell CLL in the interval between completing the last cycle of second-line induction therapy and randomization.
7. Participation in any clinical study or having taken any investigational therapy for a disease other than CLL within 28 days prior to initiating maintenance therapy.
8. Known presence of alcohol and/or drug abuse.
9. Central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging. Subjects 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.
10. Prior history of malignancies, other than CLL, unless the subject 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
11. History of renal failure requiring dialysis.
12. Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection.
13. Prior therapy with lenalidomide.
14. Evidence of TLS per the Cairo-Bishop definition of laboratory TLS (see Appendix 21.7 of)
15. Any of the following laboratory abnormalities:
Calculated creatinine clearance of <60 mL/min
Absolute neutrophil count < 2,000/μL (2.0 X 109/L)
Platelet count < 75,000/μL (75 X 109/L)
Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) > 3.0 x upper limit of normal
Serum total bilirubin > 2.0 mg/dL (with the exception of Gilbert’s Syndrome)
16. Grade 4 rash due to prior thalidomide treatment
17. Uncontrolled hyperthyroidism or hypothyroidism
18. Venous thromboembolism within one year
19. ≥ Grade-2 neuropathy
20. Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
21. Disease transformation (active) (i.e. Richter’s Syndrome, prolymphocytic leukemia)
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Other trials currently active for Chronic Lymphocytic Leukaemia
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RIAltO: A Randomised Investigation of Alternative Ofatumumabcontaining regimens in less fit patients with CLL
Combination FC plus Ofatumumab at Standard or Mega dose In CLL
GA-101 (obinutuzumab) monocLonal Antibody as Consolidation Therapy In CLL
A Phase 2, Single Arm Study Evaluating the Efficacy and Safety of Idelalisib in Combination with Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukemia with 17p Deletion