patients with relapsed or refractory mantle cell lymphoma after or not eligible for myeloablative treatment MedDRA version: 12.0 Level: PT Classification code 10026800 Term: Mantle cell lymphoma recurrent MedDRA version: 12.0 Level: PT Classification code 10026801 Term: Mantle cell lymphoma refractory
Conditions
Interventions
Trade Name: Revlimid
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Current Sponsor code: LEN
Other descriptive name: Lenalidomide
Concentration unit: mg
Sponsors
Klinikum der Universität München, Klinikum Großhadern
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed, refractory or relapsed mantle cell lymphoma according to the World Health Organization (WHO) classification 2. Histological material available for reference pathology 3. Relapse or progression following at least one adequate prior line of anti-neoplastic therapy 4. Complete or partial remission after salvage induction of 3-4 courses R-FC(M), R-B(M), or 4-6 cycles R- CHOP 5. Prior high-dose chemotherapy treatment with autologous stem cell transplantation (at least 6 months ago) or not eligible for a high dose approach 6. Age >= 18 years at the time of signing the informed consent form 7. Written informed consent 8. ECOG performance status of =1.5 x 109/L • Platelet count >= 100 x 109/L • Serum Creatinine < 2.0 mg/dL • Total serum bilirubin <= 2.0 mg/dL • AST (SGOT) and ALT (SGPT) <=3 x ULN 11. Female subjects of childbearing† potential must: o Understand the study drug is expected to have a teratogenic risk o Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout the entire duration of study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhoea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. o Understand that even if she has amenorrhea, she must follow all the advice on effective contraception. o She understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy o Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml on the day of the study visit or in the 3 days prior to the study visit once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence. The test should ensure the subject is not pregnant when she starts treatment o Agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment, except in the case of confirmed tubal sterilization. These pregnancy tests should be performed on the day of the study visit or in the 3 days prior to the study visit.. This requirement also applies to women of childbearing potential who practice complete and continued abstinence † Definition: see section 8.1 of trial protocol 12. Male subjects must o Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study drug therapy if their partner is of childbearing potential and has no contraception. o Agree not to donate semen during study drug therapy and for one week after end of study drug therapy. 13. All subjects must o Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy. o Agree not to share study drug with another person and to return all unused study drug to the investigator or pharmacist. 14. Disease free of other malignancies for more than or equal to 3 years with exception of basal cell carcinoma of the skin, incidental histological finding of prostate cancer (TNM stage of T1a or T1b) or cervical cancer in si
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 4. Use of any other experimental drug or therapy within 28 days of begin of maintenance therapy or during study participation 5. Known hypersensitivity to thalidomide 6. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs 7. Any prior use of lenalidomide 8. Concurrent use of other anti-cancer agents or treatments 9. Known HIV or active hepatitis infection, type A, B or C 10. Known acute thrombosis 11. CNS involvement of MCL 12. Biologic or immunotherapy (interferon, IL-2, B-cell specific antibodies etc.) less than 4 weeks prior to entry on this study or persistent toxic side effects of such therapy 13. Known thrombophilia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: the primary objective ist to evaluate feasibility of lenalidomide maintenance;Secondary Objective: Secondary objectives are the assessment of efficacy and the toxicity profile of lenalidomide maintenance;Primary end point(s): Feasibility of lenalidomide maintenance determined by the percentage of patients in which lenalidomide maintenance is not stopped prematurely | — |
Countries
Germany
Outcome results
None listed