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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 March 25, 2018

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Study Location
Pfizer Investigational Site
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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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
Intervention Model: Parallel Assignment
Masking: None (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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,   United States
Turkey
 
NCT01232556
B1931008
3129K5-3303
Yes
Not Provided
Not Provided
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

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