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Rituximab and Combination Chemotherapy in Treating Older Patients With Diffuse Large B-Cell Lymphoma

NCT00101010 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-10-19

Study results available
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Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating older patients with diffuse large B-cell lymphoma.

Conditions

Interventions

BIOLOGICAL

Filgrastim

5 mcg/kg, SC daily, start 24 hours after chemotherapy

BIOLOGICAL

Pegfilgrastim

6 mg SC one time (24 hours after chemotherapy)

BIOLOGICAL

Rituximab

375 mg/m\^2 intravenous piggy back (IVPB) on day 1, administered 1st

DRUG

Cyclophosphamide

750 mg/m\^2 IVPB on day 1

DRUG

Pegylated liposomal doxorubicin hydrochloride

40 mg/m\^2 IV (maximum dose 90 mg) infusion over 1 hour on day 1

DRUG

Prednisone

40 mg/m\^2 oral days 1 - 5.

DRUG

Vincristine Sulfate

2 mg IV, day 1

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Ortho Biotech, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Maria A. Rodriguez, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
61 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT00101010 on ClinicalTrials.gov