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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Lymphoma, Non-Hodgkin

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

B1931008

NCT ID:

NCT01232556

Start Date:

April 2011

Completion Date:

August 2018

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • inotuzumab ozogamicin
  • aggressive Non-Hodgkin lymphoma
  • diffuse large b-cell lymphoma
  • relapsed/refractory lymphoma
  • Aggression
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location
Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Atlanta, Georgia  30342
Pfizer Investigational Site Crestview Hills, Kentucky  41017
Pfizer Investigational Site Detroit, Michigan  48201
Pfizer Investigational Site Rochester, Minnesota  55905
Pfizer Investigational Site Cincinnait, Ohio  45236
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site Houston, Texas  77030
Pfizer Investigational Site Federal Way, Washington  98003
Pfizer Investigational Site Clearwater, Florida  33761
Pfizer Investigational Site Carmel, Indiana  46032
Pfizer Investigational Site Cedar Rapids, Iowa  52403
Pfizer Investigational Site Kansas City, Kansas  66112
Pfizer Investigational Site Columbia, Missouri  65201
Pfizer Investigational Site Bartlesville, Oklahoma  74006
Pfizer Investigational Site Eugene, Oregon  97401
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535
Pfizer Investigational Site Shreveport, Louisiana  71103
Pfizer Investigational Site Omaha, Nebraska  68198
Pfizer Investigational Site Bristol, Tennessee  37620
Pfizer Investigational Site Washington, District of Columbia  20007-2197
Pfizer Investigational Site Lebanon, New Hampshire  03766
Pfizer Investigational Site Lewistown, Idaho  83501
Pfizer Investigational Site Morgantown, West Virginia  26506