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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

Last updated on November 12, 2019

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Study Location
Disney Family Cancer Center at Providence St Joseph Medical Center
Burbank, California, 91505 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Hodgkin Lymphoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01232556
Pfizer
Terminated
A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy

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Descriptive Information
Brief Title  ICMJE A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy
Official Title  ICMJE 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
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma, Non-Hodgkin
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 24, 2018)
338
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2010)
377
Actual Study Completion Date  ICMJE March 28, 2014
Actual Primary Completion DateMarch 28, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

-

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Bulgaria,   Canada,   Croatia,   Czechia,   France,   Germany,   Hungary,   India,   Ireland,   Japan,   Lithuania,   Mexico,   Poland,   Puerto Rico,   Russian Federation,   Singapore,   Slovakia,   Spain,   Sweden,   Taiwan,   Thailand,   Ukraine,   United Kingdom,   United States
Removed Location CountriesCzech Republic,   Turkey
 
Administrative Information
NCT Number  ICMJE NCT01232556
Other Study ID Numbers  ICMJE B1931008
3129K5-3303 ( Other Identifier: Alias Study Number )
2010-020147-12 ( EudraCT Number )
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE UCB Pharma
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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