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

This study has been terminated.
(The study was terminated prematurely on May 16, 2013, for futility. No new or unexpected safety issues were identified.)
UCB Pharma
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: October 27, 2010
Last updated: May 29, 2014
Last verified: May 2014
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.

Condition Intervention Phase
Lymphoma, Non-Hodgkin
Drug: Inotuzumab ozogamicin
Drug: Rituximab
Drug: rituximab + gemcitabine
Drug: rituximab +bendamustine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, Phase 3 Study Of Inotuzumab Ozogamicin Administered In Combination With Rituximab Compared To Defined Investigator's Choice Therapy In Subjects With Relapsed Or Refractory CD22-Positive Aggressive Non-Hodgkin Lymphoma Who Are Not Candidates For Intensive High-Dose Chemotherapy

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and Tolerability: incidence of adverse events by treatment arm. [ Time Frame: ~every 6 months ] [ Designated as safety issue: Yes ]
  • Efficacy: overall response rate, progression free survival, duration of response [ Time Frame: at ~3 to 6 months after start of treatment, and ~2 years after start of treatment ] [ Designated as safety issue: No ]

Enrollment: 340
Study Start Date: April 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Inotuzumab ozogamicin+rituximab
Drug: Inotuzumab ozogamicin
1.8 mg/m2 on day 2 every 28 days by IV infusion, 3 to 6 cycles
Other Name: CMC-544
Drug: Rituximab
375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles
Active Comparator: 2
Investigator's choice of (1) rituximab+gemcitabine, or (2) rituximab+bendamustine
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • relapsed/refractory/persistent CD20+/CD22+ aggressive NHL (DLBCL, transformed indolent lymphoma with DLBCL, primary mediastinal large B-cell lymphomas)
  • up to 3 prior regimens containing cytotoxic chemotherapies
  • not candidates for intensive high-dose chemotherapy, with or without an autologous stem cell transplant

Exclusion Criteria:

  • Any prior allogeneic hematopoietic stem cell transplant; autotransplant within prior 4 months
  • anti-CD22 treatment or radioimmunotherapy within prior 6 months
  • contraindication to both investigator choice regimens
  • chronic liver disease, history of veno-occlusive disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232556

  Show 148 Study Locations
Sponsors and Collaborators
UCB Pharma
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01232556     History of Changes
Other Study ID Numbers: B1931008  3129K5-3303 
Study First Received: October 27, 2010
Last Updated: May 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
inotuzumab ozogamicin
aggressive Non-Hodgkin lymphoma
diffuse large b-cell lymphoma
relapsed/refractory lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Bendamustine Hydrochloride
Alkylating Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2016