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A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy

NCT01232556 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 338

Last updated 2019-01-08

Study results available
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Summary

The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin plus rituximab in relapsed/refractory aggressive Non-Hodgkin lymphoma patients who are not candidates for intensive high-dose chemotherapy. Specifically, the goal is to demonstrate the superiority of this combination compared with an active comparator arm (investigator's choice of rituximab+bendamustine or rituximab+gemcitabine) using the primary endpoint of overall survival.

Conditions

  • Lymphoma, Non-Hodgkin

Interventions

DRUG

Inotuzumab ozogamicin

1.8 mg/m2 on day 2 every 28 days by IV infusion, 3 to 6 cycles

DRUG

Rituximab

375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles

DRUG

rituximab + gemcitabine

rituximab 375 mg/m2 on days 1, 8, 15, and 22 of cycle 1, and day 1 of cycles 2 to 6, every 28 days by IV infusion, 3 to 6 cycles; gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 28 days, 3 to 6 cycles

DRUG

rituximab +bendamustine

rituximab 375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles; bendamustine 120 mg/m2 on days 1 and 2 by IV infusion every 28 days, 3 to 6 cycles

Sponsors & Collaborators

  • UCB Pharma

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-04
Primary Completion
2014-03-28
Completion
2014-03-28

Countries

  • United States
  • Belgium
  • Bulgaria
  • Canada
  • Croatia
  • Czechia
  • France
  • Germany
  • Hungary
  • India
  • Ireland
  • Japan
  • Lithuania
  • Mexico
  • Poland
  • Puerto Rico
  • Russia
  • Singapore
  • Slovakia
  • Spain
  • Sweden
  • Taiwan
  • Thailand
  • Ukraine
  • United Kingdom

Study Locations

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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 NCT01232556 on ClinicalTrials.gov