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)
- Conditions
- Diffuse large B cell lymphoma (DLBCL) in elderly patientsCancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
- Registration Number
- ACTRN12611000085976
- Lead Sponsor
- Australasian Leukaemia and Lymphoma Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 54
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method to determine the benefit estimated by the progression-free survival associated with lenalidomide maintenance compared to placebo in responding patients treated with R-CHOP for diffuse large B-cell lymphoma. Progression will be measured by tests such as CT scan, PET scan and Bone Marrow examination.[The primary endpoint will be analysed when a total of 160 progression or death events have occurred, or at the latest, when 5 years median follow-up has been met.]
- Secondary Outcome Measures
Name Time Method