STUDY OF LENALIDOMIDE IN MAINTENANCE VERSUS PLACEBO IN RESPONDING ELDERLY PATIENTS WITH B CELL LYMPHOMA AND PREVIOUSLY TREATED WITH R-CHOP

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 725

Inclusion Criteria

- For patients registered at the time of initial diagnosis:
• Patient with histologically proven CD20+ diffuse large B-cell
lymphoma (DLBCL) (WHO classification 2008) including clinical subtypes (primitive mediastinal, intravascular, etc.). Patients with De Novo Transformed DLBCL from low grade lymphoma (Follicular, other..) may also be included. Patients with DLBCL associated with some small cell infiltration in bone marrow may also be included
- Or CD20+ B-cell lymphoma with intermediate features between DLBCL and Burkitt or with intermediate features between DLBCL and classical Hodgkin lymphoma
- Or CD20+ Follicular lymphoma grade 3B
- Or CD20+ Agressive B-cell lymphoma unclassifiable
• Previously untreated with chemo- or radiotherapy
- For patients registered after response evaluation to first line treatment with R-CHOP:
• Patient with histologically proven CD20+ diffuse large B-cell
lymphoma (DLBCL) (WHO classification 2008) including clinical subtypes (primitive mediastinal, intravascular, etc.). Patients with De Novo Transformed DLBCL from low grade lymphoma (Follicular, other...) may also be included. Patients with DLBCL associated with some small cell infiltration in bone marrow may also be included
- Or CD20+ B-cell lymphoma with intermediate features between DLBCL and Burkitt or with intermediate features between DLBCL and classical Hodgkin lymphoma
- Or CD20+ Follicular lymphoma grade 3B
- Or CD20+ Agressive B-cell lymphoma unclassifiable
• Have reached a CR or PR (Cheson 2007) after first line treatment with at least 6 cycles of R-CHOP-14 regimens and up to 8 cycles of R-CHOP-21
• Previously untreated with Radiotherapy
For all patients:
• Aged from 60 to 80 years at time of registration
• Ann Arbor stages II-IV at time of initial diagnosis
• aaIPI = 1 at time of initial diagnosis
• Eastern Cooperative Oncology Group [ECOG] performance status 0-2
• Minimum life expectancy of 3 months
• Voluntary signed informed consent before performance of any study related procedure not part of normal medical care, with the
understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
• The following laboratory values at screening
- Absolute neutrophil count (ANC) = 1 000.106/L and Platelets = 60 000.106/L, unless these abnormalities are related to bone marrow infiltration.
- Aspartate transaminase (AST) = 5 x ULN; Alanine transaminase (ALT)
= 5 x ULN; Total bilirubin = 1.5 x ULN;
- Creatinine clearance > 30 ml/min (as calculated by the Cockcroft-
Gault formula)
• Females of childbearing potential (FCBP)† must:
- Have a negative medically supervised pregnancy test 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 patient practices complete and continued sexual abstinence.
- Either commit to continued abstinence from heterosexual intercours

Exclusion Criteria

For all patients:
1- Any other histological type of lymphoma, Burkitt included.
2- Any history of treated or non-treated small B-cell lymphoma
3- Central nervous system or meningeal involvement by lymphoma
4- Contraindication to any drug contained in the chemotherapy regimen
For example: cardiac contra-indication to anthracyclines (alteration of Left Ventricular Function defined by LVEF<50%) neurological contraindication to vincristine (peripheral neuropathy of WHO grade = 2).
5- Myocardial infarction during last 3 months or unstable coronary
disease or uncontrolled chronic symptomatic congestive heart
insufficiency NYHA III - IV
6- Uncontrolled hypertension
7- Uncontrolled diabetes mellitus as defined by the investigator
8- Active systemic infection requiring treatment.
9- Previously known HIV positive serology
10- Active hepatitis B or C
11- Prior history of malignancies other than lymphoma within 3 years (except for complete resection of basal cell carcinoma, squamous cell carcinoma of the skin, or in situ malignancy. Patients previously diagnosed with prostate cancer are eligible if (1) their disease was T1-T2a, N0, M0, with a Gleason score = 7, and a prostate specific antigen (PSA) = 10 ng/mL prior to initial therapy, (2) they had definitive curative therapy (ie, prostatectomy or radiotherapy) = 2 years before Day 1 of Cycle 1, and (3) at a minimum 2 years following therapy they
had no clinical evidence of prostate cancer, and their PSA was
undetectable if they underwent prostatectomy or <1 ng/mL if they did not undergo prostatectomy.
12- Serious medical or psychiatric illness likely to interfere with
participation in this clinical study.

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

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