CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 39 enrolled
Drug / intervention
cyclophosphamide +5 moredrug
Likely dose
cyclophosphamide 1.5gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00577629
NCT00577629Phase 2Completed
CompareCT.gov

Dose-Intensive Chemotherapy Combined With Monoclonal Antibody Therapy and Targeted Radioimmunotherapy for Untreated Patients With High-Risk B-Cell Non-Hodgkin's Lymphoma

Duke University·interventional·Posted Dec 20, 2007·Updated May 30, 2017

In Brief

A Phase 2 clinical trial evaluating cyclophosphamide, etoposide, and 4 other interventions for Lymphoma, B-Cell. Completed, enrolled 39 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, B-Cell
CountriesUnited States
CollaboratorsGlaxoSmithKline

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 20, 2007
Enrollment StartJun 18, 2005
Primary CompletionApr 8, 2012
Study CompletionNov 3, 2016
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 18.5 years ago

Interventions

cyclophosphamidedrug

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

etoposidedrug

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

rituximabdrug

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

cytarabinedrug

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

doxorubicindrug

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

tositumomabdrug

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.