MedTrace Logo

Study of Lenalidomide and Ofatumumab for the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma

NCT01060384 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-10-04

Study results available
· View outcomes & findings →

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.

Conditions

  • Non-Hodgkin's Lymphoma

Interventions

DRUG

Lenalidomide

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

DRUG

ofatumumab

8 weekly infusions of ofatumumab 1000mg.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • GlaxoSmithKline

    collaborator INDUSTRY

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Julie M Vose · University of Nebraska

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-29
Primary Completion
2016-10-25
Completion
2018-01-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01060384 on ClinicalTrials.gov