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S0213 Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma

NCT00041132 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2012-11-01

Study results available
· View outcomes & findings →

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining rituximab with chemotherapy may kill more cancer cells.

PURPOSE: Phase II pilot study to study the effectiveness of combining chemotherapy with rituximab in treating patients who have newly diagnosed mantle cell lymphoma.

Conditions

Interventions

BIOLOGICAL

filgrastim

5 ug/kg

BIOLOGICAL

rituximab

375 mg/m\^2 on day 1 of cycles 1-6

DRUG

cyclophosphamide

300 mg/m\^2 on days 2-4 of cycles 1,3,5,7

DRUG

cytarabine

12 g/m\^2 over days 3-4 of cycles 2,4,6,8

DRUG

dexamethasone

40 mg on days 2-5 and 12-15 of cycles 1,3,5,7

DRUG

doxorubicin

16.6 mg/m\^2/day for days 5-7 of cycles 1,3,5,7

DRUG

leucovorin

170 mg over days 3-5 of cycles 2,4,6,8

DRUG

methotrexate

1000 mg/m\^2 over days 2-3 of cycles 2,4,6,8

DRUG

vincristine

1.4 mg/m\^2 on days 5 and 12 of cycles 1,3,5,7

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Elliot M. Epner, MD, PhD · OHSU Knight Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-09-30
Primary Completion
2007-11-30
Completion
2011-06-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00041132 on ClinicalTrials.gov