CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
Lenalidomide +1 moredrug
Likely dose
Lenalidomide 10mgfrom 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/NCT01060384
NCT01060384Phase 2Completed
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Phase I/II Study of Lenalidomide and Ofatumumab for the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma

University of Nebraska·interventional·Posted Feb 2, 2010·Updated Oct 4, 2023

In Brief

A Phase 2 clinical trial evaluating Lenalidomide and ofatumumab for Non-Hodgkin's Lymphoma. Completed, enrolled 46 participants across 2 sites.

Detailed Summary

The purpose of this trial is to investigate the efficacy (how well the drug works) of ofatumumab and lenalidomide in patients with lymphoma and to investigate if any possible unwanted side effects may occur. The purpose of the Phase I portion of this trial will be to determine the maximum dose of these medications that can be given with minimal side effects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Hodgkin's Lymphoma
CountriesUnited States
CollaboratorsCelgene Corporation, GlaxoSmithKline

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2, 2010
Enrollment StartMar 29, 2010
Primary CompletionOct 25, 2016
Study CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 16.4 years ago

Interventions

Lenalidomidedrug

Dose Cohort -1\^ 10mg daily on Days 1-21 every 28 days Dose Cohort +1\^\^ 15mg daily on Days 1-21, every 28 days Dose Cohort +2 20 mg daily on Days 1-21, every 28 days Dose Cohort #3 25 mg daily on Days 1-21, every 28 days \^Used only if Dose Cohort +1 requires further reduction \^\^Starting Dose Cohort in Phase I

ofatumumabdrug

8 weekly infusions of ofatumumab 1000mg.