CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
denileukin diftitox +1 morebiological
Likely dose
Not stated in record
Key inclusion· 8
  • Pathologically confirmed follicular B-cell non-Hodgkin's lymphoma
  • Stage III or IV disease
  • Grade 1 or 2 disease
  • Previously untreated disease
Key exclusion· 5
  • CNS lymphoma
  • HIV infection
  • Other active malignancies
  • Active uncontrolled infection

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

Search/NCT00460109
NCT00460109Phase 2Completed

A Phase II Clinical Trial of Denileukin Diftitox in Combination With Rituximab in Previously Untreated Follicular B-Cell Non-Hodgkin's Lymphoma

Alliance for Clinical Trials in Oncology·interventional·Posted Apr 13, 2007·Updated Apr 18, 2017

In Brief

A Phase 2 clinical trial evaluating denileukin diftitox and rituximab for Lymphoma. Completed, enrolled 24 participants across 165 sites.

Detailed 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. Combinations of biological substances in denileukin diftitox may be able to carry cancer-killing substances directly to cancer cells. Giving rituximab together with denileukin diftitox may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with denileukin diftitox works in treating patients with previously untreated stage III or stage IV follicular B-cell non-Hodgkin's lymphoma.

Study Details

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

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 13, 2007
Enrollment StartApr 1, 2008
Primary CompletionOct 1, 2010
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 19.2 years ago

Interventions

denileukin diftitoxbiological

rituximabbiological