Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With Diffuse Large B cell Lymphoma (DLBCL) and Treated With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)
Double blind randomized phase III study of Lenalidomide (Revlimid Registered Trademark) maintenance versus Placebo in responding elderly patients with diffuse large B cell lymphoma (DLBCL) and treated with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in first line
Australasian Leukaemia and Lymphoma Group
80 participants
Mar 8, 2011
Interventional
Conditions
Summary
In patients between 60-80 years with diffuse large B cell lymphoma (DLBCL), the current standard treatment is R-CHOP chemotherapy (consisting of the drugs Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone). However the probability of being alive and free of lymphoma 5 years after diagnosis is only 54%. Lenalidomide is an immune system modulating drug that has anti-lymphoma properties demonstrated in smaller studies of patients with relapsed/refractory DLBCL. Given the high risk of relapsed DLBCL in this older patient population this study is aimed at determining whether Lenalidomide maintenance taken orally for 21 days every 4 weeks can safely reduce the risk of progression/relapse of DLBCL. Who is it for? This study is open to patients aged between 60 and 80 years and currently underoing R-CHOP combination therapy for diffuse large B-cell lymphoma. Trial details Participants will be randomised into one of two arms, (1) 25mg daily lenalidomide for 21 days of a 28 day cycle of maintenenace therapy for up to 26 cycles, or (2) a placebo instead of the active drug over the same period. The aim of the study is to reduce the risk of progression/relapse of DLBCL
Eligibility
Inclusion Criteria19
- For patients registered at the time of initial diagnosis
- initial diagnosis of histologically confirmed CD20+ DLBCL
- previously untreated with chemo- or radiotherapy
- For patients registered after response evaluation to first line treatment with R-CHOP:
- Diagnosis of histologically confirmed CD20+ diffuse large B-Cell Lymphoma
- Have reached a CR or PR after first line treatment with at least 6 cycles of R-CHOP 14 regimen or up to 8 cycles of R-CHOP21
- Previously untreated with Radiotherapy
- For all patients:
- aged from 60 to 80 years at time of initial diagnosis
- Ann Arbor stages II-IV at time of initial diagnosis
- age-adjusted International Prognostic Index greater than 1 at time of initial diagnosis
- Eastern Cooperative Oncology Group performance status 0-2
- Minimum life expectancy of 3 months
- Following laboratory values at screening:
- absoloute neutrophil count greater than or equal to 1000x10^6/Litre and Platelets greater than or equal to 60000x10^6/Litre
- Aspartate transaminase (AST) less than or equal to 5x Upper limit of normal (ULN), Alanine transaminase (ALT) less than or equal to 5xULN, Total Bilirubin less than or equal to 1.5xULN
- Creatinine clearance>30mL/min
- Women of childbearing potential are using effective contraception, are not pregnant and agree not to become pregnant during participation in the trial and after end of study. Men agree to use a condom during sexual contact with a female, even if they have had a vasectomy, and to not donate semen or sperm throughout study drug therapy, during any dose interruption and during the 12 months thereafter.
- Having previously signed a written informed consent form
Exclusion Criteria13
- 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.
- Myocardial infarction during last 3 months or unstable coronary disease or uncontrolled chronic
- symptomatic congestive heart insufficiency New York Heart Association III-IV
- Uncontrolled hypertension
- Uncontrolled diabetes mellitus as defined by the investigator
- Active systemic infection requiring treatment.
- Previously known human immunodeficiency virus (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)
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
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Interventions
25mg daily lenalidomide for 21 days of a 28 day cycle of maintenance therapy for up to 26 cycles. Lenalidomide is an oral tablet.
Locations(3)
View Full Details on ANZCTR
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ACTRN12611000085976