Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
- Conditions
- For the treatment of patients with B-cell chronic lymphocytic leukemia who have failed at least 1 prior therapyMedDRA version: 18.0Level: LLTClassification code 10003946Term: B-Lymphocytic, CLL (Kiel Classification)System Organ Class: 100000004864Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2009-009836-54-SE
- Lead Sponsor
- Celgene Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 105
• Must understand and voluntarily sign an informed consent form
• Age = 18 years at the time of signing the informed consent form
• Must be able to adhere to the study visit schedule and other protocol requirements
Must have a documented diagnosis of B-cell CLL [iwCLL guidelines for diagnosis and treatment of CLL (Hallek, 2008)] 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
- Must be relapsed or refractory to at least 1 prior regimen for treatment of CLL [relapsed / refractory as defined per the iwCLL guidelines for diagnosis and treatment of CLL (Hallek, 2008)]. At least one of the prior treatments must have included a purine-analog or bendamustine based treatment regimen
- Relapsed is defined as a subject who has previously achieved the criteria of a complete remission (CR) or partial remission (PR), but after a period of =6 months, demonstrates evidence of disease progression
- Refractory is defined as treatment failure [e.g. Stable disease (SD), non response, or progressive disease] or disease progression within 6 months to the last antileukemic therapy
• Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of =2.
• Females of childbearing potential (FCBP) must:
- Have a negative medically supervised pregnancy test prior to starting study drug. She must agree to ongoing pregnancy testing during study therapy and after discontinuation of study drug. 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, prior to starting study drug, during study drug therapy, and after discontinuation of study drug.
• Male subjects must:
- Agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, during study drug therapy and after discontinuation of study drug.
- Agree to not donate semen or sperm during study drug therapy and after discontinuation of study drug.
• All subjects must:
- Have an understanding that the study drug could have a potential teratogenic risk
- Agree to abstain from donating blood during study drug therapy and after discontinuation of study drug.
- Agree not to share study drug with another person
- Be counseled about pregnancy precautions and risks of fetal exposure.
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 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for thi
• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
• Active infections requiring systemic antibiotics
• Systemic treatment for B-cell CLL within 28 days of initiation of lenalidomide treatment
• Alemtuzumab therapy within 60 days of initiating lenalidomide treatment
• Prior therapy with lenalidomide
• History of grade 4 rash due to prior thalidomide treatment
• Planned autologous or allogeneic bone marrow transplantation
• Pregnant or lactating females
• 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 initiating study drug
• Prior history of malignancies, other than CLL, unless the subject has been free of the disease for =5 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
- Carcinoma in situ of the bladder
- Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
• History of renal failure requiring dialysis
• Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection
• Evidence of TLS per the Cairo-Bishop definition of laboratory TLS (subjects may be enrolled upon correction of electrolyte abnormalities)
• Any of the following laboratory abnormalities:
- Calculated (method of Cockroft-Gault) creatinine clearance of <60 mL/min (creatinine clearance may also be obtained by the 24-hour collection method at the investigator’s discretion)
- 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) > 3.0 x upper limit of normal (ULN)
- Serum total bilirubin > 1.5 x ULN
• Uncontrolled hyperthyroidism or hypothyroidism
• Venous thromboembolism within 12 months
• = Grade-2 neuropathy
• Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
• Disease transformation [i.e. Richter’s Syndrome (lymphomas) or prolymphocytic leukemia]
• Participation in any clinical study or having taken any investigational therapy within 28 days prior to initiating lenalidomide therapy
Known presence of alcohol and/or drug abuse
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety of different lenalidomide dose regimens in subjects with relapsed or refractory B-cell CLL. ;Secondary Objective: To evaluate the efficacy of different lenalidomide dose regimens in subjects with relapsed or refractory B-cell CLL. ;Primary end point(s): Safety [type, frequency, and severity of adverse events (AEs) and relationship of AEs to lenalidomide].;Timepoint(s) of evaluation of this end point: 24 months post LPFV
- Secondary Outcome Measures
Name Time Method Secondary end point(s): *Response rate [per the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines for diagnosis and treatment of CLL (Hallek, 2008)<br><br>*Duration of response, Time to response, Time to progression, Event-free survival, Progression-free survival, Overall survival ;Timepoint(s) of evaluation of this end point: 24 months post LPFV