Clinical trial · Interventional
Phase II Study to Evaluate the Combination of Rituximab and DepoCyte® in the C5R Chemotherapy Protocol in Patients Between the Ages of 18 and 60 Years With Primary Cerebral Non-Hodgkin Lymphoma and Systemic Diffuse Large B-cell Lymphoma With Neuromeningeal Invasion at Diagnosis
Prospective Multicentre Phase II Study to Evaluate the Combination of Rituximab and DepoCyte® by Intrathecal Injection in the C5R Chemotherapy Protocol in Patients Between the Ages of 18 and 60 Years With Primary Cerebral Non-Hodgkin Lymphoma and Systemic Diffuse Large B-cell Lymphoma With Neuromeningeal Invasion at Diagnosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to measure the rate of complete response (CR and UCR) at the end of a course of immuno-chemotherapy: * before cerebral radiotherapy for PCL * after the course of immuno-chemotherapy for aggressive lymphomas with neuromeningeal involvement Toxicity of the protocol Overall survival Survival without relapse Long-term incidence of neurocognitive toxicity
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytarabine | Drug | Cytarabine | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rituximab + Cytarabine
- interventionNames
- Drug: Rituximab
- Drug: Cytarabine
Primary outcomes (1)
- measure
- Response to treatment (CR/PR)
- timeFrame
- End of treatment - 5 months
Secondary outcomes (1)
- measure
- Toxicity, Overall survival, Time to progression
- timeFrame
- End of study - 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available