Refractory or relapsed chronic lymphocytic leukemia (CLL) MedDRA version: 9.1 Level: LLT Classification code 10008976 Term: Chronic lymphocytic leukemia
Conditions
Interventions
Trade Name: Revlimid
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Lenalidomide
CAS Number: 191732-72-6
Concentration unit: mg milligram(s)
Concentration type: equal
Product Name: Revlimid
Sponsors
Deptartment of Hematology, Karolinska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Understand and voluntarily sign an informed consent form. 2. Age >=18 years at the time of signing the informed consent form. 3. Able to adhere to the study visit schedule and other protocol requirements. 4. Diagnosed with CLL and failed chemotherapy for CLL defined as refractory or relapsed with new need of treatment within 12 months after chemotherapeutic regimens in use for CLL therapy. 5. All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to first treatment dose in this study. 6. ECOG performance status of =0.5 x 109/L - Platelet count >=25 x 109/L - Serum creatinine 177 µmol/L - Total bilirubin 26 µmol/L - ASAT (SGOT) and ALAT (SGPT) = 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix or breast. 9. Able to take aspirin (75 or 160 mg) daily as prophylactic anticoagulation, unless patients intolerant to ASA may use low molecular weight heparin. If platelet count =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. 2. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide). 3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. 4. Use of any other experimental therapy within 28 days of baseline. 5. Any prior use of lenalidomide or thalidomide. 6. Concurrent use of other anti-cancer agents or treatments. 7. Known positive for HIV or infectious hepatitis, type A, B or C. 8. Opportunistic infections within the last 4 months. 9. Previous alemtuzumab therapy within the last 4 months. 10. Renal impairment, defined as calculated creatinine clearance below 60mL/min as defined by the method of Cockroft-Gault. 11. Evidence of pre-existing TLS per the Cairo-Bishop definition of laboratory TLS(Subjects may be enrolled upon correction of electrolyte abnormalities). 12. History of renal failure requiring dialysis. 13. Uncontrolled hemolytic anemia or autoimmune thrombocytopenia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of the combination of lenalidomide and alemtuzumab in subjects with relapsed or refractory CLL.;Secondary Objective: To evaluate the efficacy of the combination of lenalidomide and alemtuzumab in subjects with relapsed or refractory CLL.;Primary end point(s): To evaluate the safety (type, frequency, and severity) of adverse events (AEs) and relationship of AEs to lenalidomide and alemtuzumab treatment. | — |
Countries
Sweden
Outcome results
None listed