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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

This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Collaborator:
UCB, Inc.
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01232556
First received: October 27, 2010
Last updated: May 17, 2013
Last verified: May 2013
History of Changes
  Purpose

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:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 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 ]
  • Patient-reported health-related quality of life [ Time Frame: approximately 3 to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 377
Study Start Date: April 2011
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: June 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

  Eligibility

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

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

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021
Contact: Pfizer Oncology Clinical Trial Information Service 1-877-369-9753 PfizerCancerTrials@emergingmed.com

  Show 170 Study Locations
Sponsors and Collaborators
Pfizer
UCB, Inc.
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

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 17, 2013
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:
Aggression
Lymphoma
Lymphoma, Non-Hodgkin
Behavioral Symptoms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Bendamustine
Rituximab
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 19, 2013