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A Study Of Inotuzumab Ozogami...

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

Last Updated: 2019-01-08

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

338 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-04

Study Completion Date

2014-03-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Lymphoma, Non-Hodgkin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Inotuzumab ozogamicin+rituximab

Group Type EXPERIMENTAL

Inotuzumab ozogamicin

Intervention Type DRUG

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

Rituximab

Intervention Type DRUG

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

2

Investigator's choice of (1) rituximab+gemcitabine, or (2) rituximab+bendamustine

Group Type ACTIVE_COMPARATOR

rituximab + gemcitabine

Intervention Type DRUG

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

rituximab +bendamustine

Intervention Type DRUG

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

Interventions

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Inotuzumab ozogamicin

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

Intervention Type DRUG

Rituximab

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

Intervention Type DRUG

rituximab + gemcitabine

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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CMC-544

Eligibility Criteria

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Inclusion Criteria

Exclusion Criteria

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Disney Family Cancer Center at Providence St Joseph Medical Center

Burbank, California, United States

Site Status

Providence St Joseph Medical Center

Burbank, California, United States

Site Status

Hematology-Oncology Medical Group of Fresno Inc

Fresno, California, United States

Site Status

Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services

Los Angeles, California, United States

Site Status

Clinical Research Unit

Los Angeles, California, United States

Site Status

Peter Morton Medical Plaza

Los Angeles, California, United States

Site Status

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Site Status

Sansum Clinic

Santa Barbara, California, United States

Site Status

UCLA Santa Monica Hematology Oncology

Santa Monica, California, United States

Site Status

Sansum Clinic

Solvang, California, United States

Site Status

Howard University Hospital

Washington D.C., District of Columbia, United States

Site Status

Mount Sinai Comprehensive Cancer Center at Aventura

Aventura, Florida, United States

Site Status

University Cancer Institute

Boynton Beach, Florida, United States

Site Status