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Genes in Predicting Outcome of Patients With DLBCL Treated With Rituximab and Combination Chemotherapy (R-CHOP)

NCT00450385 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2017-06-23

Study results available
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Summary

The investigators hypothesize that survival of newly diagnosed DLBCL (diffuse large B-cell lymphoma) patients treated with R-CHOP can be predicted by RNA or protein gene expression or by presence of biomarkers associated with the anti-tumor effects of Rituximab.

Conditions

Interventions

DRUG

Rituximab

Rituximab 375 mg/m2 on day 1 for 6 to 8 cycles

DRUG

Cyclophosphamide

Cyclophosphamide 750 mg/m2 IV on day 1 for 6 to 8 cycles

DRUG

Doxorubicin

Doxorubicin 50 mg/m2 on day 1 for 6 to 8 cycles

DRUG

Prednisone

Prednisone 40 mg/m2 orally days 1-5, repeated every 21 days for 6 to 8 cycles.

DRUG

Vincristine

Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1 for 6 to 8 cycles

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Izidore S. Lossos, MD · University of Miami

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2007-04-24
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00450385 on ClinicalTrials.gov