Status:
COMPLETED
R-CHOP-14 Versus R-CHOP-21 and Darbepoetin Alpha in Patients Aged 60-80 Years With Diffuse Large B-cell Lymphoma
Lead Sponsor:
Lymphoma Study Association
Collaborating Sponsors:
Amgen
Conditions:
Diffuse Large Cell Lymphoma
Eligibility:
All Genders
60-80 years
Phase:
PHASE3
Brief Summary
This study is a multicentric randomized trial evaluating the efficacy and safety of R-CHOP given every 14 days compared to R-CHOP given every 21 days in association or not with darbepoetin alfa in ord...
Detailed Description
In patients aged 60 to 75 years with diffuse large B-cell lymphoma, the shortening of interval between the courses of CHOP combination (CHOP-14), improves the complete response rate, the progression f...
Eligibility Criteria
Inclusion
- Patients with histologically proven CD20+ diffuse large B cell lymphoma (WHO Classification).
- Aged 66 to 80 years old. Patients not previously treated. Ann Arbor stage II, III, IV. ECOG performance status 0 to 2. Age-adjusted IPI equal to 1, 2, or 3. With a minimum life expectancy of 3 months. Negative HIV, HBV and HCV serologies test \< 4 weeks (except after vaccination for HBV).
- Having signed a written informed consent.
Exclusion
- Any other histological type of lymphoma. Any history of treated or non-treated indolent lymphoma. However, patients not previously diagnosed and having a diffuse large B-cell lymphoma with some small cell infiltration in bone marrow or lymph node may be included.
- Central nervous system or meningeal involvement by lymphoma. Contra-indication to any drug contained in the chemotherapy regimens. Any serious co-morbid active disease (according to the investigator's decision).
- Poor renal function (creatinin level \> 150 micromol/l), poor hepatic function (total bilirubin level \> 30mmol/l, transaminases \> 2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
- Poor bone marrow reserve as defined by neutrophils \< 1.5 G/l or platelets \< 100 G/l, unless related to bone marrow infiltration.
- Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
- Uncontrolled hypertension. Known hypersensitivity to erythropoietin. Myocardial infarction during last 3 month, or unstable coronary disease, or uncontrolled cardiac insufficiency.
- Venous thrombosis or pulmonary embolism during last 3 months. Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
- Pregnant or lactating women. Adult patient under tutelage.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00144755
Start Date
December 1 2003
End Date
December 1 2012
Last Update
September 2 2015
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
Université de Gent
Ghent, Belgium
2
Groupe d'Etude des Lymphomes de l'adulte
Mont-Godinne, Belgium
3
Polyclinique Bordeaux Nord
Bordeaux, France, 33300
4
Hôpital Henri Mondor
Créteil, France, 94010