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Study Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator's Choice In Follicular Non-Hodgkin's Lymphoma (NHL)

NCT00562965 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2018-01-09

Study results available
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Summary

This protocol is designed to assess the efficacy and safety of inotuzumab ozogamicin given with rituximab compared to a defined investigator's choice therapy. Subjects will be randomized to one of these two arms of the study.

Conditions

  • Lymphoma, Follicular

Interventions

DRUG

inotuzumab ozogamicin

IV administration, 1.8mg/m² on day 2 of each cycle every 28 days, for up to 8 cycles.

DRUG

rituximab

IV administration, 375 mg/m² on day 1 of each cycle every 28 days, for up to 8 cycles.

DRUG

rituximab

intravenous rituximab at a dose of 375 mg/m2 on day 1

DRUG

cyclophosphamide

intravenous cyclophosphamide at a dose of 750 mg/m2 on day 1

DRUG

vincristine

intravenous vincristine at a dose of 1.4 mg/m2 (not to exceed 2 mg) on day 1

DRUG

prednisone/prednisolone

oral prednisone/prednisolone at a dose of 40 mg/m2 on days 1 through 5

DRUG

mitoxantrone

mitoxantrone 10 mg/m2 intravenous on day 2

DRUG

fludarabine

fludarabine 25 mg/m2 intravenous on days 2 through 4

DRUG

dexamethasone

oral dexamethasone 20 mg/day on days 1-5

Sponsors & Collaborators

  • UCB Pharma

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States
  • Argentina
  • Belgium
  • Canada
  • Hong Kong
  • India
  • Italy
  • Mexico
  • Poland
  • Portugal
  • Russia
  • South Africa
  • South Korea
  • Spain

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 NCT00562965 on ClinicalTrials.gov