Study of frontline-prophylatic darbepoetin alpha treatment versus usual symptomatic treatment of anemia in non previously treated patients aged 60 to 80 years, with CD20+ diffuse large B-cell lymphoma MedDRA version: 9.1 Level: HLT Classification code 10012819 Term: Diffuse large B-cell lymphomas
Conditions
Interventions
Trade Name: Aranesp 150 mcg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: darbepoetin alfa
CAS Number: 11096-26-7
Other descriptive name: DARBEPOETIN ALFA
Concentration unit: Bq/µg
Sponsors
Groupe d'Etudes des Lymphomes de l'Adult
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO Classification). DLBCL with some small cell infiltration in bone marrow or lymph node may be included; Aged from 60 to 80; patient not previously treateed; Ann Arbor stage II, III and IV;Age-adjusted IPI 1, 2 or 3; ECOG Performance status 0 to 2; with a minimum life expectancy of 3 months; negative HIV, HBV and HCV serologies « weeks (except after vacination) and having previously signed a written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any other histological type of lymphoma; Any history of threated or non-treated indolent lymphoma; 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 > 150 mmol/l), poor hepatic function (total bilirrubin level > 30 mmol/l, transaminases > 2.5 maximum normal level) unless these abnormalitiesare related to the lymphoma; Poor bone marrow reserve as defined by neutrophils < 1.5 G/l or platelets < 100 G/l, unless related to none marrow infiltration; Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma; Uncontrolled hypertension, Myocardial infarction during the last 3 months or unstable coronary disease or uncontrolled cardiac insuffiency; Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study; Adult patient under tutelage.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the efficacy and the safety of intensified R-CHOP (R-CHOP 14) versus R-CHOP 21 and evaluation of the efficacy of frontline/prophilatic darbepoetin alfa treatment versus treatment of symptomatic anemia.;Secondary Objective: Efficacy of treatment with darbepoetin alfa (ARANESP) to improve EFS. Efficacy and safety measured as response rate at the end of the treatment, progression rate, relapse rate, disease-free survival for complete responders, overall survival amd additional toxicities with R-CHOP 14. Efficacy and safety measured as response rate, overall survival, disease-free survival for complete responders and predictive factors of haemotological response with frontline/prophylatic darbepoetin alfa (ARANESP) compared to treatment of symptomatic anemia (transfusion or darbepoetin alfa).;Primary end point(s): Comparison (R-CHOP 14 versus R-CHOP 21) of the event-free survival, using the log-rank test. Kaplan-Meier plot of time to first event of each treatment group will also produce. An improvement of 10% in EFS at 3 years is expected by R-CHOP 14. | — |
Countries
Portugal
Outcome results
None listed