DOUBLE BLIND RANDOMIZED PHASE III STUDY OF LENALIDOMIDE (REVLIMID®) MAINTENANCE VERSUS PLACEBO IN RESPONDING ELDERLY PATIENTS WITH DLBCL AND TREATED WITH R-CHOP IN FIRST LINE
- Conditions
- Diffuse Large B Cell LymphomaMedDRA version: 21.0Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2008-008202-52-PT
- Lead Sponsor
- YSARC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 650
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 intercourse
(which must be reviewed on a monthly basis) or agree to use, and be
able to comply with, effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including
dose interruptions), and for 28 days after discontinuation of study
therapy.
• Male patients 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 or sperm during
For all patients:
• Any other histological type of lymphoma, Burkitt included.
• Any history of treated or non-treated small B-cell lymphoma
• Central nervous system or meningeal involvement by lymphoma
• 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).
• Myocardial infarction during last 3 months or unstable coronary
disease or uncontrolled chronic symptomatic congestive heart
insufficiency NYHA III - IV
• Uncontrolled hypertension
• Uncontrolled diabetes mellitus as defined by the investigator
• Active systemic infection requiring treatment.
• Previously known HIV positive serology
• Active hepatitis B or C
• 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.
• 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