Etude prospective multicentrique de phase II évaluant l’adjonction du rituximab et du DepoCyte® en intrathécal au protocole de chimiothérapie C5R chez les patients âgés de 18 à 60 ans porteurs de lymphomes non hodgkiniens cérébraux primitifs et de lymphomes systémiques diffus à grandes cellules B avec envahissement neuro-méningé au diagnostic.
- Conditions
- Patiens with primary cerebral or oculocerebral NHL not previously treated with chemotherapy or radiotherapy and diffuse large B-cell lymphomas, with cerebral and / or neuromeningeal involvement at diagnosisMedDRA version: 9.1Level: LLTClassification code 10012820Term: Diffuse large B-cell lymphoma NOS
- Registration Number
- EUCTR2006-000454-44-FR
- Lead Sponsor
- Groupe d’Etude des Lymphomes de l’Adulte (GELA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
-Primary cerebral or oculocerebral NHL not previously treated with chemotherapy or radiotherapy and diffuse large B-cell lymphomas, with cerebral and / or neuromeningeal involvement at diagnosis.
-Diagnosis proved by histological or cytological examination of cerebral specimens, CSF or vitreous humour.
-Diffuse large cell CD20+ lymphoma.
-Men or women between the ages of 18 and 60 years.
-Presence of a measurable target to evaluate response.
-Negative serological tests for HIV, hepatitis B (except in cases of vaccination), hepatitis C.
-Life-expectancy = 3 months
-Patient having given written consent to participate in this study.
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) no
F.1.3.1 Number of subjects for this age range
-CD20- lymphoma.
-History of indolent lymphoma, treated or untreated.
-Contraindication for one of the products used in polychemotherapy.
-Known hypersensitivity to mouse antibodies.
-Absence of measurable target to evaluate response.
-History of cancer in the 5 years prior to inclusion except for cutaneous basocellular carcinomas and non-invasive carcinomas of the neck of the uterus.
-Cardiac contraindication to treatment with anthracyclines or to hyperhydration:
- SEVERE DISTURBANCE OF HEART RHYTHM
- VENTRICULAR EJECTION FRACTION BELOW 50%
- HISTORY OF RECENT MYOCARDIAL INFARCTION
-Previously known severe renal insufficiency and/or creatinaemia >150 µM/L (apart from invasion of the kidneys by the lymphoma).
-Total bilirubin >30 µmol/L, ASAT, ALAT >2.5 times the upper normal value (apart from invasion of the liver by the lymphoma).
-Insufficient medullary reserve: PNL < 1 G/L and platelets <100 G/L (apart from invasion of the medulla by the lymphoma).
-History of organ transplantation or other causes of severe immunosuppression.
-Pregnant woman.
-Patient incapable of keeping to regular monitoring.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To measure the rate of complete response (CR and UCR) at the end of a course of immuno-chemotherapy:<br>-before cerebral radiotherapy for PCL<br>-after the course of immuno-chemotherapy for aggressive lymphomas with neuromeningeal involvement<br>;Secondary Objective: Toxicity of the protocol<br>Overall survival<br>Survival without relapse<br>Long-term incidence of neurocognitive toxicity<br>;Primary end point(s): To evaluate the complete response rate after the immuno-chemotherapy. A 50% response rate is expected.
- Secondary Outcome Measures
Name Time Method