CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled
Drug / intervention
ONTAKdrug
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Pathologically confirmed low-grade (indolent) B-cell non-Hodgkin's lymphoma
  • ✓CD25 expression >20% of malignant cells by immunohistochemistry on lymph node biopsy
  • ✓Ann Arbor Stage I, II, III, or IV
  • ✓2–5 prior therapies: at least one cytotoxic chemotherapy and at least one monoclonal antibody
Key exclusion· 8
  • ✕Cutaneous T-cell lymphoma
  • ✕Prior treatment with ONTAK or related agents (DAB389IL-2, DAB486IL-2)
  • ✕HIV seropositive
  • ✕Active hepatitis B or C infection

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

Search/NCT00051025
NCT00051025Phase 2Completed
CompareCT.gov

A Randomized, Multicenter, Phase II Evaluation of ONTAK (Denileukin Diftitox) in Patients With Previously Treated, Indolent, B-Cell, Non-Hodgkin's Lymphoma

Eisai Inc.·interventional·Posted Jan 3, 2003·Updated Jul 13, 2012

In Brief

A Phase 2 clinical trial evaluating ONTAK for Non-Hodgkin's Lymphoma and 2 related conditions. Completed, enrolled 9 participants across 2 sites.

Detailed Summary

The purpose of this study is to look at the safety and effectiveness of ONTAK in previously treated patients with NHL.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Hodgkin's Lymphoma, Lymphoma, B-cell, Lymphoma, Low-grade
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 3, 2003
Enrollment StartMay 1, 2000
Primary CompletionJan 1, 2001
Study CompletionSep 1, 2006
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 23.5 years ago

Interventions

ONTAKdrug