E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10012819 |
E.1.2 | Term | Diffuse large B-cell lymphomas |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 8 |