Mantle Cell Lymphoma
Conditions
Interventions
addition of lenalidomide to maintenance treatment.
Sponsors
LYSARC (The Lymphoma Academic Research Organisation)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Randomization 1: 1. signed informed consent form 2. Biopsy-proven mantle cell lymphoma according to WHO classification, including evidence of cyclin D1 overexpression or the translocation t(11;14)(q13;q32), 3. >= 60 years of age and ineligible for autologous transplant 4. Ann Arbor stage II-IV 5. previously untreated (except for patients randomized directly for maintenance treatment who will receive 8 RCHOP before registration in the trial) 6. ECOG performance status
Exclusion criteria
Exclusion criteria: Randomization 1: 1. Female of child-bearing potential (without natural menopause for at least 24 consecutive months, a hysterectomy or bilateral oophorectomy) 2. Any of the following laboratory abnormalities, if not related to lymphoma: - Absolute neutrophils count (ANC) 3.0 x upper limit of normal (ULN). - Serum total bilirubin > 1.5 UNL (except if due to Gilbert*s syndrome) 3. Calculated creatinine clearance (Cockcroft-Gault formula or MDRD) = 5 years (Exceptions: Basal or squamous cell carcinoma of the skin, Carcinoma in situ of the cervix or of the breast, Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b). 7. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient to receive the study medication as planned. 8. Poor cardiac function (LVEF = Grade 3 allergic hypersensitivity to thalidomide. 12. Prior >= Grade 3 rash or any desquamating (blistering) rash while taking thalidomide. 13. Subjects with >= Grade 2 neuropathy. 14. Known anti-murine antibody (HAMA) reactivity or known hypersensitivity to murine antibodies 15. Prior use of lenalidomide. 16. Participation in another clinical trial within three weeks before randomization in this study., Randomization 2: The presence of any exclusion criteria of randomization 1 or of the following criteria will exclude a subject from enrollment in the maintenance phase: 17. SD or PD after induction treatment determined as per Cheson 1999 criteria assessed by investigator. 18. Patients who had not received at least 6 cycles of R-CHOP21 or 2 cycles of R-CHOP21 / 2 cycles of R-HAD28 (alternating) 19. Patients with serious underlying medical conditions, which could impair the ability to receive maintenance treatment 20. Calculated creatinine clearance (Cockcroft-Gault formula or MDRD) of < 30 mL /min a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) from randomization for maintenance to progression or death from any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| • Time to event : - overall survival from induction randomization to death from any cause - overall survival from maintenance randomization to death from any cause - time to treatment failure, progression-free survival from induction randomization, remission duration • PR/CRu to CR and PR to CRu conversion during maintenance • Minimal residual disease (MRD) status and levels in peripheral blood and bone marrow at midterm and at the end of induction, after one and two years from end of induction and during follow-up until progression or up to 2.5 years of follow-up whichever comes first • complete and overall response rates (based on Cheson 1999 criteria) at midterm and end of induction, • safety according to NCI CTCAE (v 4.0) • secondary primary malignancies rates after lenalidomide vs. no lenalidomide • Exploratory : response assessment according to Cheson 2007 criteria including FDG-PET evaluation | — |
Countries
Netherlands
Outcome results
None listed