Trial record 1 of 1 for:    B1931008
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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 has been terminated.
(The study was terminated prematurely on May 16, 2013, for futility. No new or unexpected safety issues were identified.)
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01232556
First received: October 27, 2010
Last updated: May 29, 2014
Last verified: May 2014

October 27, 2010
May 29, 2014
April 2011
March 2014   (final data collection date for primary outcome measure)
Overall Survival [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01232556 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma, Non-Hodgkin
  • 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
  • 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
  • Experimental: 1
    Inotuzumab ozogamicin+rituximab
    Interventions:
    • Drug: Inotuzumab ozogamicin
    • Drug: Rituximab
  • Active Comparator: 2
    Investigator's choice of (1) rituximab+gemcitabine, or (2) rituximab+bendamustine
    Interventions:
    • Drug: rituximab + gemcitabine
    • Drug: rituximab +bendamustine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
340
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Bulgaria,   Canada,   Croatia,   Czech Republic,   France,   Germany,   Hungary,   India,   Ireland,   Japan,   Lithuania,   Mexico,   Poland,   Puerto Rico,   Russian Federation,   Singapore,   Slovakia,   Spain,   Sweden,   Taiwan,   Thailand,   Ukraine,   United Kingdom
 
NCT01232556
B1931008, 3129K5-3303
Yes
Pfizer
Pfizer
UCB Pharma
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP