Clinical trial NCT00562965: Study Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator's Choice In Follicular Non-Hodgkin's Lymphoma (NHL)
Official title: An Open-label, Randomized, Phase 3 Study Of Inotuzumab Ozogamicin (Cmc-544) Administered In Combination With Rituximab Compared To A Defined Investigator's Choice Therapy In Subjects With Relapsed Or Refractory, Cd22- Positive, Follicular B-cell Non Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Lymphoma, Follicular
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: UCB Pharma
First posted: 2007-11-26
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Baseline until disease progression or death or up to 1 year after last dose of study drug
Secondary outcomes:
measure: Percentage of Participants With Objective Response (OR)
timeFrame: Baseline, every 6 to 12 weeks during treatment period, end of treatment (EOT) (42 days after last dose), every 12 weeks during follow-up for up to 1 year after the last dose of study drug
measure: Overall Survival Probability at Months 6, 12 and 24
timeFrame: Baseline up to Month 6, 12, 24
measure: Pharmacokinetics of Inotuzumab Ozogamicin in Combination With Rituximab
timeFrame: 0, 1, 168 hours on Cycle 1, 2; 0, 1, 2, 168 hours on Cycle 3, 4
Other outcomes:
measure: Number of Participants With Clinically Significant Change From Baseline in QT Interval Findings
timeFrame: Baseline up to 42 days post-treatment
measure: Number of Participants With Grade 3 or 4 Treatment Emergent Adverse Events (TEAEs)
timeFrame: Baseline up to 42 days post-treatment
measure: Number of Participants With Clinically Significant Change From Baseline in Laboratory Findings
timeFrame: Baseline up to 42 days post-treatment, disease follow up (every 12 weeks for a minimum of 1 year and up to 2 years)
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
timeFrame: Baseline up to 42 days post-treatment, disease follow up (every 12 weeks for a minimum of 1 year and up to 2 years)
Locations:
city: Mission Hills
country: United States
facility: Facey Medical Group
state: California
city: Evansville
country: United States
facility: Deaconess Clinic
state: Indiana
city: Baltimore
country: United States
facility: The Harry & Jeanette Weinberg Cancer Inst at Franklin Square
state: Maryland
city: Novi
country: United States
facility: Newland Medical Associates
state: Michigan
city: Southfield
country: United States
facility: Newland Medical Associates, PC
state: Michigan
city: Saint Louis Park
country: United States
facility: Park Nicollet Frauenshuh Cancer Center
state: Minnesota
city: Columbus
country: United States
facility: Hematology and Oncology Associates
state: Mississippi
city: Corinth
country: United States
facility: Hematology and Oncology Associates
state: Mississippi
city: Tupelo
country: United States
facility: Hematology and Oncology Associates at Bridgepoint
state: Mississippi
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Hackensack
country: United States
facility: The Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Hematology Oncology Associates of Northern New Jersy
state: New Jersey
city: Armonk
country: United States
facility: Advanced Oncology Associates
state: New York
city: Bronx
country: United States
facility: Avi Einzing, MD
state: New York
city: New Rochelle
country: United States
facility: Advanced Oncology Associates
state: New York
city: Pomona
country: United States
facility: Marc Zimmerman, MD
state: New York
city: Wenatchee
country: United States
facility: Wenatchee Valley Medical Center
state: Washington
city: Rosario
country: Argentina
facility: Centro de Transplantes de medula Osea de Rosario, CETRAMOR
state: Santa FE
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Wilrijk
country: Belgium
facility: Oncologisch Centrum GZA - Location St. Augustinus
city: Greenfield Park
country: Canada
facility: Hopital Charles LeMoyne
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS-Hopital Fleurimont
state: Quebec
city: Quebec
country: Canada
facility: C.H.A. Enfant-Jesus
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
state: NEW Territories
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Pune
country: India
facility: Jehangir Clinical Development Centre
state: Maharashtra
city: Pune
country: India
facility: MMF Joshi Hospital and Ratna Memorial Hospital
state: Maharashtra
city: Kolkata
country: India
facility: B. P. Poddar Hospital and Medical Research Ltd.
state: WEST Bengal
city: Pavia
country: Italy
facility: Divisione di Ematologia - Fondazione IRCCS Policlinico San Matteo
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System-Severance Hospital
city: Monterrey
country: Mexico
facility: Hospital Universitario de Nuevo Leon
state: Nuevo LEON
city: Warszawa
country: Poland
facility: Instytut Hematologii i Transfuzjologii
city: Coimbra
country: Portugal
facility: Hospitais Da Universidade De Coimbra
city: Moscow
country: Russian Federation
facility: Moscow Regional Research Clinical Institute named after Vladimirsky
city: Johannesburg
country: South Africa
facility: Wits Donald Gordon Clinical Trial Site
state: Gauteng
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Santa Creu I Sant Pau
city: Madrid
country: Spain
facility: Hospital de La Princesa
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: