Study Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator's Choice In Follicular Non-Hodgkin's Lymphoma (NHL)

Stopped early · Phase 3

Conditions studied: Lymphoma, Follicular

In brief

This protocol is designed to assess the efficacy and safety of inotuzumab ozogamicin given with rituximab compared to a defined investigator's choice therapy. Subjects will be randomized to one of these two arms of the study.

Key facts

Study ID

NCT00562965

Run by

Pfizer

People needed

29

Starts

2007-11-01

Expected to finish

2011-04-01

Last updated by the study team

2018-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with a diagnosis of CD20 and CD22-positive, follicular lymphoma, who have received 1 or 2 prior regimens, at least 1 of which should have contained administration of rituximab (either as a single agent or in combination).
• Age 18 years or older.
• ECOG performance status <= 2.
• ANC >= 1.5 x 10\^9/L (1500/mL) and platelets >= 75 x 10\^9/L (75,000/mL), serum creatinine <= 1.5 x ULN and urine protein to creatinine ratio of <= 0.5, total bilirubin <= 1.5 x ULN, AST and ALT <= 2.5 x ULN.
• At least 1 measurable disease lesion that is >= 1.5 cm x 1.5 cm by CT or MRI, in an area of no prior radiation therapy, or documented progression in an area that was previously irradiated.

You may not qualify if…

• Subjects with clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3b follicular lymphoma.
• Subjects whose disease is rituximab refractory, meaning that they did not have a CR or PR, or that they experienced disease progression within 6 months from the initiation of the rituximab or rituximab containing treatment regimen administered immediately preceding study enrollment.

Where it is running

• Facey Medical Group — Mission Hills, California, United States
• Deaconess Clinic — Evansville, Indiana, United States
• The Harry & Jeanette Weinberg Cancer Inst at Franklin Square — Baltimore, Maryland, United States
• Newland Medical Associates — Novi, Michigan, United States
• Newland Medical Associates, PC — Southfield, Michigan, United States
• Park Nicollet Frauenshuh Cancer Center — Saint Louis Park, Minnesota, United States
• Hematology and Oncology Associates — Columbus, Mississippi, United States
• Hematology and Oncology Associates — Corinth, Mississippi, United States
• Hematology and Oncology Associates at Bridgepoint — Tupelo, Mississippi, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• The Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
• Hematology Oncology Associates of Northern New Jersy — Morristown, New Jersey, United States
• Advanced Oncology Associates — Armonk, New York, United States
• Advanced Oncology Associates — New Rochelle, New York, United States
• Marc Zimmerman, MD — Pomona, New York, United States
• Avi Einzing, MD — The Bronx, New York, United States
• Wenatchee Valley Medical Center — Wenatchee, Washington, United States
• Centro de Transplantes de medula Osea de Rosario, CETRAMOR — Rosario, Santa Fe Province, Argentina
• Universitair Ziekenhuis Gent — Ghent, Belgium
• Oncologisch Centrum GZA - Location St. Augustinus — Wilrijk, Belgium
• Hopital Charles LeMoyne — Greenfield Park, Quebec, Canada
• Jewish General Hospital — Montreal, Quebec, Canada
• C.H.A. Enfant-Jesus — Québec, Quebec, Canada
• CHUS-Hopital Fleurimont — Sherbrooke, Quebec, Canada
• Prince of Wales Hospital — Shatin, NEW Territories, Hong Kong

Full record on ClinicalTrials.gov

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