Study of the efficacy and safety of lenalidomide as maintenance therapy for high risk patients with chronic lymphocytic leukemia.
- Conditions
- Maintenance therapy in high risk patients with CLLMedDRA version: 14.1Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10008958Term: Chronic lymphocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-004698-98-ES
- Lead Sponsor
- Deutsche CLL-Studiengruppe, Innere Medizin I, Uniklinik Köln
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 89
1. Must understand and voluntarily sign an informed consent form.
2. Age more or equal 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 CLL (IWCLL guidelines for the diagnosis and treatment of chronic lymphocytic leukemia1).
5. Must have been treated with one of the first line induction therapies: fludarabine/cyclophosphamide/rituximab, or bendamustine/rituximab or fludarabine/rituximab or fludarabine/cyclophosphamide,(in case of hypersensitivity reactions to Rituximab).
6. Must have achieved a response of at least PR (IWCLL guidelines for the diagnosis and treatment of chronic lymphocytic leukemia [Hallek, 2008]) following completion (minimum 4 cycles) of first-line induction therapy prior to randomization (documentation of response status must be available).
and have either:
a. MRD levels in the peripheral blood at final restaging of major or equal 10(-2) or
b. MRD levels in the peripheral blood major or equal 10(-4) - <10(-2) combined with at least one of the following factors: an unmutated IGHV-status , 17p-deletion or TP53 mutation.
7. Must have completed last cycle of at least 4 cycles of first-line induction no less than 8 weeks (56 days) and no greater than 20 weeks (140 days) prior to randomization.
8. Subjects who completed first line induction treatment with less than 6 but at least 4 cycles should document reason for early discontinuation
9. Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of minor or equal to 2.
10. Negative serological Hepatitis B test, negative testing of Hepatitis C RNA, negative HIV test within 6 weeks prior to randomization.
11. Females of childbearing potential (FCBP) must:
Have two negative medically supervised pregnancy tests prior to starting of study therapy. She must 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, two reliable forms of effective contraception simultaneously to achieve a PEARL-Index <1 without interruption (Highly effective methods: Intrauterine device (IUD), Hormonal (birth control pills, injections, implants), Tubal ligation, Partner?s vasectomy, Additional effective methods: Male condom, Diaphragm, Cervical Cap), 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy.
12. Male subjects 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 to not donate semen during study drug therapy and for a period after end of study drug therapy.
13. 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.
Be counseled about pregnancy precautions and risks of fetal exposure.
14. Willingness to inform the general practicioner
Are the trial subjects under 18? no
Number of sub
1. A CIRS Score of more than 6 or a single score of 4 for an organ system limiting the ability to receive an intensive therapy for CLL
2. Active infections requiring systemic antibiotics.
3. Systemic infection CTC grade 3 or 4 that has not resolved > 2 months prior to randomization in spite of adequate anti-infective therapy.
4. Autologous or allogeneic bone marrow transplant as first line therapy.
5. Pregnant or lactating females.
6. Systemic treatment for CLL in the interval between completing the last cycle of first-line induction therapy and randomization.
7. Participation in any clinical study or having taken any investigational therapy which would interfere with the study drug 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 major or equal than 5 years.
11. History of renal failure requiring dialysis.
12. Prior therapy with lenalidomide.
13. Any of the following laboratory abnormalities:
Calculated (method of Cockroft-Gault) creatinine clearance of <60 mL/min
absolute neutrophil count (ANC) < 1,000/microL (1.0 X 109/L)
Platelet count < 50,000/microL (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 > 2.0 mg/dL (with the exception of Gilberts Syndrome)
14. Uncontrolled hyperthyroidism or hypothyroidism
15. Venous thromboembolism within one year
16. Major or equal Grade-2 neuropathy
17. Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
18. Disease transformation (active) (i.e. Richters Syndrome, prolymphocytic leukemia)
19. Known allergy to allopurinol, if the subject has bulky disease
20. Prisoners or subjects who are institutionalized by regulatory or court order or persons who are in dependence to the sponsor or an investigator
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method