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Study of Veltuzumab and 90Y-Epratuzumab in Relapsed/Refractory, Aggressive NHL

NCT01101581 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2021-08-18

No results posted yet for this study

Summary

The goal of this study is to evaluate a new approach to immunotherapy in NHL by combining two antibodies, veltuzumab and epratuzumab. For treatment, epratuzumab has also been attached to a radioactive isotope called 90yttrium (90Y-epratuzumab). Veltuzumab and 90Y-epratuzumab attack different areas on lymphoma cells. Because of this, treatment with the combination may provide more effective treatment in NHL than either veltuzumab or 90Y-epratuzumab given alone.

Conditions

  • Non Hodgkin's Lymphoma
  • NHL
  • Aggressive NHL
  • Diffuse Large B-cell Lymphoma

Interventions

DRUG

Veltuzumab and 90Y-Epratuzumab Tetraxetan

Veltuzumab will be administered subcutaneously in phase 2. 90Y-Epratuzumab tetraxetan will be administered intravenously. Veltuzumab is given once weekly for 4 weeks. 90Y-Epratuzumab is also given at treatment weeks 2 \& 3 (days 8 \& 15).

DRUG

90Y-epratuzumab tetraxetan

DRUG

veltuzumab

Veltuzumab will be administered subcutaneously on days 1, 8, 15 and 23

Sponsors & Collaborators

Principal Investigators

  • William Wegener, MD, PhD · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2016-12-31
Completion
2017-03-31

Countries

  • United States

Study Locations

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Entities

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 NCT01101581 on ClinicalTrials.gov