A Study of MabThera (Rituximab) in Primary Central Nervous System Lymphoma.

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-03-31

Brief Summary

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This study will evaluate the efficacy and safety of MabThera plus high dose methotrexate plus high dose cytarabine in patients with central nervous system non-Hodgkin's lymphoma. Eligible patients will receive a treatment regimen consisting of MabThera (750mg/m2 iv) plus methotrexate (8g/m2 iv) given at intervals up to week 22, plus cytarabine (2g/m2 iv) at week 11 and week 22. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

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Detailed Description

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Conditions

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Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

rituximab [MabThera/Rituxan]

Intervention Type DRUG

750mg/m2 iv

Methotrexate

Intervention Type DRUG

8g/m2 iv

Cytarabine

Intervention Type DRUG

2g/m2 iv

Interventions

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rituximab [MabThera/Rituxan]

750mg/m2 iv

Intervention Type DRUG

Methotrexate

8g/m2 iv

Intervention Type DRUG

Cytarabine

2g/m2 iv

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, 18-80 years of age;
* histological diagnosis of primary central nervous system lymphoma;
* B-cell proliferation verified by positive staining for CD20;
* \>=1 measurable lesion.

Exclusion Criteria

* prior chemotherapy, other than corticosteroids, \>=6 weeks before and after diagnosis or surgery;
* history of prior cranial irradiation;
* evidence of plurisystemic non-Hodgkin's lymphoma;
* other active malignant disease (other than basal cell or squamous cell cancer of skin,or cancer in situ of cervix;
* uncontrolled active infection.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No