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

Last updated: December 8, 2017
Sponsor: Pfizer
Overall Status: Terminated

Phase

3

Condition

Lymphoma

Follicular Lymphoma

Treatment

fludarabine

rituximab

dexamethasone

Clinical Study ID

NCT00562965
3129K4-3301
2007-000219-27
B1931006
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects with a diagnosis of CD20 and CD22-positive, follicular lymphoma, who havereceived 1 or 2 prior regimens, at least 1 of which should have containedadministration 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), serumcreatinine <= 1.5 x ULN and urine protein to creatinine ratio of <= 0.5, totalbilirubin <= 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 anarea of no prior radiation therapy, or documented progression in an area that waspreviously irradiated.

Exclusion

Exclusion Criteria:

  • Subjects with clinical evidence of transformation to a more aggressive subtype oflymphoma or grade 3b follicular lymphoma.

  • Subjects whose disease is rituximab refractory, meaning that they did not have a CR orPR, or that they experienced disease progression within 6 months from the initiationof the rituximab or rituximab containing treatment regimen administered immediatelypreceding study enrollment.

Study Design

Total Participants: 29
Treatment Group(s): 8
Primary Treatment: fludarabine
Phase: 3
Study Start date:
November 01, 2007
Estimated Completion Date:
April 30, 2011

Study Description

On January 14th 2009, enrollment in the study was discontinued because of poor enrollment and because it was unlikely that the study would meet the estimated enrollment of approximately 978 subjects. The decision was not prompted by the identification of any safety signals in this or other studies. Active treatment and follow-up of the already enrolled subjects was continued. On July, 22th 2010 , the study was amended to shorten the long-term follow-up to one year after active treatment.

Connect with a study center

  • Centro de Transplantes de medula Osea de Rosario, CETRAMOR

    Rosario, Santa FE S2000AYW
    Argentina

    Site Not Available

  • Pfizer Investigational Site

    Canberra, Australian Capital Territory 2606
    Australia

    Site Not Available

  • Pfizer Investigational Site

    Brisbane, Queensland 4029
    Australia

    Site Not Available

  • Pfizer Investigational Site

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Pfizer Investigational Site

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Site Not Available

  • Oncologisch Centrum GZA - Location St. Augustinus

    Wilrijk, 2610
    Belgium

    Site Not Available

  • Pfizer Investigational Site

    Sao Paulo, SP 09060-650
    Brazil

    Site Not Available

  • Hopital Charles LeMoyne

    Greenfield Park, Quebec J4V 2H1
    Canada

    Site Not Available

  • Jewish General Hospital

    Montreal, Quebec H3T 1E2
    Canada

    Site Not Available

  • CHUS-Hopital Fleurimont

    Sherbrooke, Quebec J1H 5N4
    Canada

    Site Not Available

  • C.H.A. Enfant-Jesus

    Quebec, G1J 1Z4
    Canada

    Site Not Available

  • Pfizer Investigational Site

    Sremska Kamenica, Novi Sad 21204
    Former Serbia and Montenegro

    Site Not Available

  • Pfizer Investigational Site

    Belgrad, 11000
    Former Serbia and Montenegro

    Site Not Available

  • Pfizer Investigational Site

    Zemun, 11080
    Former Serbia and Montenegro

    Site Not Available

  • Pfizer Investigational Site

    Koblenz, 56068
    Germany

    Site Not Available

  • Pfizer Investigational Site

    Koeln, 50677
    Germany

    Site Not Available

  • Pfizer Investigational Site

    Stuttgart, 70376
    Germany

    Site Not Available

  • Prince of Wales Hospital

    Shatin, NEW Territories
    Hong Kong

    Site Not Available

  • Queen Mary Hospital

    Hong Kong,
    Hong Kong

    Site Not Available

  • Jehangir Clinical Development Centre

    Pune, Maharashtra 411001
    India

    Site Not Available

  • MMF Joshi Hospital and Ratna Memorial Hospital

    Pune, Maharashtra 411004
    India

    Site Not Available

  • Pfizer Investigational Site

    Ludhiana, Punjab 141001
    India

    Site Not Available

  • B. P. Poddar Hospital and Medical Research Ltd.

    Kolkata, WEST Bengal 700053
    India

    Site Not Available

  • Divisione di Ematologia - Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100
    Italy

    Site Not Available

  • Pfizer Investigational Site

    Roma, 00183
    Italy

    Site Not Available

  • Yonsei University Health System-Severance Hospital

    Seoul, 120-752
    Korea, Republic of

    Site Not Available

  • Hospital Universitario de Nuevo Leon

    Monterrey, Nuevo LEON 64460
    Mexico

    Site Not Available

  • Pfizer Investigational Site

    Puebla, 72530
    Mexico

    Site Not Available

  • Pfizer Investigational Site

    San Borja, Lima LIMA 41
    Peru

    Site Not Available

  • Pfizer Investigational Site

    Lima, Lima/Peru LIMA 34
    Peru

    Site Not Available

  • Pfizer Investigational Site

    Gdansk, 80-952
    Poland

    Site Not Available

  • Pfizer Investigational Site

    Krakow, 31-501
    Poland

    Site Not Available

  • Pfizer Investigational Site

    Poznan, 60-569
    Poland

    Site Not Available

  • Instytut Hematologii i Transfuzjologii

    Warszawa, 02-776
    Poland

    Site Not Available

  • Hospitais Da Universidade De Coimbra

    Coimbra, 3000-075
    Portugal

    Site Not Available

  • Pfizer Investigational Site

    San Juan, 00910
    Puerto Rico

    Site Not Available

  • Moscow Regional Research Clinical Institute named after Vladimirsky

    Moscow, 120110
    Russian Federation

    Site Not Available

  • Pfizer Investigational Site

    Novosibirsk, 630087
    Russian Federation

    Site Not Available

  • Pfizer Investigational Site

    Saint Petersburg, 197022
    Russian Federation

    Site Not Available

  • Pfizer Investigational Site

    Ufa, 450054
    Russian Federation

    Site Not Available

  • Pfizer Investigational Site

    Ulyanovsk, 432063
    Russian Federation

    Site Not Available

  • Pfizer Investigational Site

    Voronezh, 394000
    Russian Federation

    Site Not Available

  • Pfizer Investigational Site

    Nis, 18000
    Serbia

    Site Not Available

  • Pfizer Investigational Site

    Singapore, 169608
    Singapore

    Site Not Available

  • Pfizer Investigational Site

    Bratislava, 83313
    Slovakia

    Site Not Available

  • Pfizer Investigational Site

    Kosice, 04166
    Slovakia

    Site Not Available

  • Pfizer Investigational Site

    Presov, 081 81
    Slovakia

    Site Not Available

  • Wits Donald Gordon Clinical Trial Site

    Johannesburg, Gauteng 2193
    South Africa

    Site Not Available

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid 28222
    Spain

    Site Not Available

  • Hospital Santa Creu I Sant Pau

    Barcelona, 08041
    Spain

    Site Not Available

  • Hospital de La Princesa

    Madrid, 28006
    Spain

    Site Not Available

  • Pfizer Investigational Site

    Taichung, 404
    Taiwan

    Site Not Available

  • Pfizer Investigational Site

    Taipei, 11217
    Taiwan

    Site Not Available

  • Pfizer Investigational Site

    Bangkok, 10700
    Thailand

    Site Not Available

  • Facey Medical Group

    Mission Hills, California 91345
    United States

    Site Not Available

  • Deaconess Clinic

    Evansville, Indiana 47713
    United States

    Site Not Available

  • The Harry & Jeanette Weinberg Cancer Inst at Franklin Square

    Baltimore, Maryland 21237
    United States

    Site Not Available

  • Newland Medical Associates

    Novi, Michigan 48374
    United States

    Site Not Available

  • Newland Medical Associates, PC

    Southfield, Michigan 48075
    United States

    Site Not Available

  • Park Nicollet Frauenshuh Cancer Center

    Saint Louis Park, Minnesota 55426
    United States

    Site Not Available

  • Pfizer Investigational Site

    St. Louis Park, Minnesota 55426
    United States

    Site Not Available

  • Hematology and Oncology Associates

    Columbus, Mississippi 39706
    United States

    Site Not Available

  • Hematology and Oncology Associates

    Corinth, Mississippi 38834
    United States

    Site Not Available

  • Hematology and Oncology Associates at Bridgepoint

    Tupelo, Mississippi 38801
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • The Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Hematology Oncology Associates of Northern New Jersy

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Advanced Oncology Associates

    Armonk, New York 10504
    United States

    Site Not Available

  • Avi Einzing, MD

    Bronx, New York 10461
    United States

    Site Not Available

  • Advanced Oncology Associates

    New Rochelle, New York 10801
    United States

    Site Not Available

  • Marc Zimmerman, MD

    Pomona, New York 10970
    United States

    Site Not Available

  • Wenatchee Valley Medical Center

    Wenatchee, Washington 98801
    United States

    Site Not Available

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