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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 SiteBlendora, California  91740
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteCrestview Hills, Kentucky  41017
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteRochester, Minnesota  55905
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteCedar Rapids, Iowa  52403
Pfizer Investigational SiteKansas City, Kansas  66112
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteBartlesville, Oklahoma  74006
Pfizer Investigational SiteEugene, Oregon  97401
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteShreveport, Louisiana  71103
Pfizer Investigational SiteOmaha, Nebraska  68198
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteWashington, District of Columbia  20007-2197
Pfizer Investigational SiteLebanon, New Hampshire  03766
Pfizer Investigational SiteLewistown, Idaho  83501
Pfizer Investigational SiteMorgantown, West Virginia  26506