CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 86 enrolled
Drug / intervention
rituximab +5 morebiological
Likely dose
I-131 tositumomab in combination with cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (specific doses not stated in interventions or arms)AI-extracted
Key inclusion· 6
  • Diagnosis of diffuse large B-cell non-Hodgkin's lymphoma at bulky stage II, stage III, or stage IV
  • CD20 antigen-positive disease confirmed
  • Bidimensionally measurable disease present
  • Circulating lymphoid cells <20,000/mcL on WBC differential
Key exclusion· 8
  • Prior antibody therapy for lymphoma
  • Prior chemotherapy for lymphoma
  • Prior radiotherapy for lymphoma
  • Clinical evidence of CNS involvement by lymphoma

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

Search/NCT00107380
NCT00107380Phase 2Completed

Iodine-131-Labeled Monoclonal Anti-B1 Antibody (I-131 Tositumomab) in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients ≥ Age 60 With Advanced Stage Diffuse Large B-Cell NHL: A Phase II Study

SWOG Cancer Research Network·interventional·Posted Apr 6, 2005·Updated Mar 7, 2016

In Brief

A Phase 2 clinical trial evaluating rituximab, cyclophosphamide, and 4 other interventions for Lymphoma. Completed, enrolled 86 participants across 78 sites.

Detailed Summary

RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can find cancer cells and carry cancer-killing substances to them without harming normal cells. 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, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving a radiolabeled monoclonal antibody together with rituximab and combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving iodine I 131 tositumomab together with rituximab and combination chemotherapy works in treating older patients with stage II, stage III, or stage IV B-cell non-Hodgkin's lymphoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesUnited States

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 6, 2005
Enrollment StartNov 1, 2005
Primary CompletionNov 1, 2013
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8 yearsPosted 21.2 years ago

Interventions

rituximabbiological

cyclophosphamidedrug

doxorubicin hydrochloridedrug

prednisonedrug

vincristine sulfatedrug

tositumomab and iodine I 131 tositumomabradiation