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

NCT ID: NCT00562965

Last Updated: 2018-01-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2011-04-30

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.

Conditions

Lymphoma, Follicular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

A

Subjects will receive rituximab intravenously at a dose level of 375 mg/m² on day 1 of each cycle followed by inotuzumab ozogamicin administered intravenously at a dose level of 1.8 mg/m2 on day 2. The sequence will be repeated every 28 days.

Group Type: EXPERIMENTAL

inotuzumab ozogamicin

Intervention Type: DRUG

IV administration, 1.8mg/m² on day 2 of each cycle every 28 days, for up to 8 cycles.

rituximab

Intervention Type: DRUG

IV administration, 375 mg/m² on day 1 of each cycle every 28 days, for up to 8 cycles.

B

Subjects will receive the investigator's choice from the following rituximab-containing regimens: R-CVP or R-FND. The investigator's choice of therapy will be administered every 21 days. Dosing for R-CVP will be intravenous rituximab at a dose of 375 mg/m2 on day 1, intravenous cyclophosphamide at a dose of 750 mg/m2 on day 1, intravenous vincristine at a dose of 1.4 mg/m2 (not to exceed 2 mg) on day 1, and oral prednisone/prednisolone at a dose of 40 mg/m2 on days 1 through 5. Dosing for R-FND will be as follows: rituximab 375 mg/m2 intravenous on day 1, mitoxantrone 10 mg/m2 intravenous on day 2, fludarabine 25 mg/m2 intravenous on days 2 through 4 and oral dexamethasone 20 mg/day on days 1-5.

Group Type: ACTIVE_COMPARATOR

rituximab

Intervention Type: DRUG

intravenous rituximab at a dose of 375 mg/m2 on day 1

cyclophosphamide

Intervention Type: DRUG

intravenous cyclophosphamide at a dose of 750 mg/m2 on day 1

vincristine

Intervention Type: DRUG

intravenous vincristine at a dose of 1.4 mg/m2 (not to exceed 2 mg) on day 1

prednisone/prednisolone

Intervention Type: DRUG

oral prednisone/prednisolone at a dose of 40 mg/m2 on days 1 through 5

mitoxantrone

Intervention Type: DRUG

mitoxantrone 10 mg/m2 intravenous on day 2

fludarabine

Intervention Type: DRUG

fludarabine 25 mg/m2 intravenous on days 2 through 4

dexamethasone

Intervention Type: DRUG

oral dexamethasone 20 mg/day on days 1-5

Interventions

inotuzumab ozogamicin

IV administration, 1.8mg/m² on day 2 of each cycle every 28 days, for up to 8 cycles.

Intervention Type: DRUG

rituximab

IV administration, 375 mg/m² on day 1 of each cycle every 28 days, for up to 8 cycles.

Intervention Type: DRUG

rituximab

intravenous rituximab at a dose of 375 mg/m2 on day 1

Intervention Type: DRUG

cyclophosphamide

intravenous cyclophosphamide at a dose of 750 mg/m2 on day 1

Intervention Type: DRUG

vincristine

intravenous vincristine at a dose of 1.4 mg/m2 (not to exceed 2 mg) on day 1

Intervention Type: DRUG

prednisone/prednisolone

oral prednisone/prednisolone at a dose of 40 mg/m2 on days 1 through 5

Intervention Type: DRUG

mitoxantrone

mitoxantrone 10 mg/m2 intravenous on day 2

Intervention Type: DRUG

fludarabine

fludarabine 25 mg/m2 intravenous on days 2 through 4

Intervention Type: DRUG

dexamethasone

oral dexamethasone 20 mg/day on days 1-5

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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

Queen Mary Hospital

Hong Kong, , Hong Kong

Jehangir Clinical Development Centre

Pune, Maharashtra, India

MMF Joshi Hospital and Ratna Memorial Hospital

Pune, Maharashtra, India

B. P. Poddar Hospital and Medical Research Ltd.

Kolkata, West Bengal, India

Divisione di Ematologia - Fondazione IRCCS Policlinico San Matteo

Pavia, , Italy

Hospital Universitario de Nuevo Leon

Monterrey, Nuevo León, Mexico

Instytut Hematologii i Transfuzjologii

Warsaw, , Poland

Hospitais Da Universidade De Coimbra

Coimbra, , Portugal

Moscow Regional Research Clinical Institute named after Vladimirsky

Moscow, , Russia

Wits Donald Gordon Clinical Trial Site

Johannesburg, Gauteng, South Africa

Yonsei University Health System-Severance Hospital

Seoul, , South Korea

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Hospital Santa Creu I Sant Pau

Barcelona, , Spain

Hospital de La Princesa

Madrid, , Spain

Countries

United States; Argentina; Belgium; Canada; Hong Kong; India; Italy; Mexico; Poland; Portugal; Russia; South Africa; South Korea; Spain

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3129K4-3301&StudyName=Study%20Comparing%20Inotuzumab%20Ozogamicin%20In%20Combination%20With%20Rituximab%20Versus%20Defined%20Investigator%27s%20Choice%20In%20Follicular%20Non-Hodgkin%27s%20Lymp

To obtain contact information for a study center near you, click here.

Other Identifiers

B1931006

Identifier Type: OTHER

Identifier Source: secondary_id

2007-000219-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

3129K4-3301

Identifier Type: -

Identifier Source: org_study_id