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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


Phase 2
18 Years
60 Years
Open (Enrolling)
Both
Lymphoma, Non-Hodgkin, Diffuse Large B-cell Lymphoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response to treatment (CR/PR)

Outcome Time Frame:

End of treatment

Safety Issue:

No

Principal Investigator

Herve Ghesquieres, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Groupe d'Etude des Lymphomes de l'Adulte (GELA)

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

R-C5R 2006

NCT ID:

NCT00553943

Start Date:

July 2007

Completion Date:

June 2013

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • Diffuse Large B-Cell Lymphoma
  • lymphoma
  • cerebral lymphoma
  • central nervous system
  • cytarabine
  • rituximab
  • Diffuse large B-cell lymphomas, with cerebral or neuromeningeal involvement
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

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