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Study Evaluating Inotuzumab Ozogamicin [CMC-544] Administered In Combination With Rituximab In Subjects With Non-Hodgkin's Lymphoma (NHL)

NCT00299494 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2018-03-08

Study results available
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Summary

The purpose of the study is to determine the tolerability, the initial safety profile and maximum tolerated dose, and to obtain preliminary information on the antitumor activity of inotuzumab ozogamicin \[CMC-544\] in combination with rituximab in subjects with follicular, diffuse large B-Cell, or mantle cell NHL.

Conditions

Interventions

DRUG

inotuzumab ozogamicin

IV, 1.8 mg/m2, q4w

DRUG

inotuzumab ozogamicin

IV, 1.8 mg/m2, q4w

DRUG

inotuzumab ozogamicin

IV, 1.8 mg/m2, q4w

DRUG

Rituximab

rituximab 375 mg/m\^2 via IV infusion on Day 1

Sponsors & Collaborators

  • UCB Pharma

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-04
Primary Completion
2014-05-19
Completion
2014-06-02

Countries

  • United States
  • Australia
  • Belgium
  • France
  • Germany
  • Hong Kong
  • Italy
  • Netherlands
  • Poland
  • South Korea
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT00299494 on ClinicalTrials.gov