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Chemotherapy With Monoclonal Antibody and Radioimmunotherapy for High-Risk B-Cell Non-Hodgkins Lymphoma

NCT00577629 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2017-05-30

Study results available
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Summary

The purpose of this study is to determine whether using high-dose chemotherapy, monoclonal antibodies, and targeted radioimmunotherapy will slow the progression of disease in patients with high-risk Non-Hodgkin's Lymphoma (NHL).

Conditions

  • Lymphoma, B-Cell

Interventions

DRUG

cyclophosphamide

1.5g/m2 IV over 1 hour on days 1-4 of induction for a total dose of 6.0g/m2

DRUG

etoposide

300mg/m2 IV over 1 hour every 12 on days 1-3 of induction for a total dose of 1.8 g/m2.

DRUG

rituximab

375mg/m2 each week x 4 weeks of induction, beginning on day 1

DRUG

cytarabine

3g/m2 IV over 1 hour every 12 during consolidation for a total of 8 doses

DRUG

doxorubicin

45mg/m2/day IV over 30 minutes on days 1, 2, 3 during consolidation

DRUG

tositumomab

450mg unlabeled tositumomab over 1 hour, followed by 5 millicurie (mCi) Iodine I-131 labeled tositumomab over 20 minutes on day 0. Therapeutic dose of labeled tositumomab will be administered on day 15.

Sponsors & Collaborators

Principal Investigators

  • David Rizzieri, MD · Duke Unversity Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-18
Primary Completion
2012-04-08
Completion
2016-11-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT00577629 on ClinicalTrials.gov