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An Open Label Study of the Effect of Rituxan, High Dose Methotrexate and High Dose Cytarabine on Response Rate in Patients With Primary Central Nervous System Lymphoma.


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

An Open Label Study of the Effect of Rituxan, High Dose Methotrexate and High Dose Cytarabine on Response Rate in Patients With Primary Central Nervous System Lymphoma.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response rate;overall response rate

Outcome Time Frame:

Event driven

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Canada: Health Canada

Study ID:

ML19652

NCT ID:

NCT00517699

Start Date:

September 2007

Completion Date:

March 2009

Related Keywords:

  • Lymphoma
  • Lymphoma

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