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 August 2012 by Pfizer

First Received on October 27, 2010.  
Last Updated on August 13, 2012  
History of Changes
This Clinical Trial Sponsored By: Pfizer
Collaborator: UCB, Inc.
Information provided by (Responsible Party): Pfizer
ClinicalTrials.gov Identifier: NCT01232556
 

Purpose for Clinical Trial

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 Study Intervention Clinical Trial Phase
Lymphoma, Non-Hodgkin
Lymphoma, B-cell
Lymphoma, B-cell, Diffuse
Drug: Inotuzumab ozogamicin
Drug: Rituximab
Drug: rituximab + gemcitabine
Drug: rituximab +bendamustine
Phase 3

Study Type: Study Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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
Drug Information available for:
Bendamustine hydrochloride
Bendamustine
Gemcitabine
Gemcitabine hydrochloride
Rituximab

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures For Clinical Trial:

  • Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures For Clinical Trial:

  • 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: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Arms

Assigned Study 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 195 Study Locations

Sponsors and Collaborators
Pfizer
UCB, Inc.

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