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

Sponsor
Lymphoma Study Association
Study ID
NCT00553943
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    375 mg/m2 D1
  • Cytarabine — DRUG
    50 mg D3

Study Details

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

Key Dates

Start date
Jul 31, 2007
Status verified
Aug 2018
Primary completion
Jun 30, 2012
Completion
Mar 31, 2017

Study Design

Enrollment
60 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab + Cytarabine

Primary Outcome Measure

Response to treatment (CR/PR) [ Time Frame: End of treatment - 5 months ]

Related Studies