Phase II Study to Evaluate the Combination of Rituximab and DepoCyte® in the C5R Chemotherapy Pro… (NCT00553943) | Clinical Trial Compass
CompletedPhase 2
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
Belgium, France60 participantsStarted 2007-07
Plain-language summary
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
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 fro…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.