Study Evaluating Inotuzumab Ozogamicin [CMC-544] Administered In Combination With Rituximab In Subjects With Non-Hodgkin's Lymphoma (NHL)

NCT00299494 | Completed Phase 1 Results

• 3 other identifiers: 3129K3-101B19310042005-005436-27
• Study Type: interventional
• Target: 119
• Locations: 13 countries
• Sites: 38

Brief Summary

The purpose of the study is to determine the tolerability, the initial safety profile and maximum tolerated dose, and to obtain preliminary information on the antitumor activity of inotuzumab ozogamicin \[CMC-544\] in combination with rituximab in subjects with follicular, diffuse large B-Cell, or mantle cell NHL.

Conditions

B-Cell Lymphoma

Keywords

Lymphoma; NHL

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose (MTD) of Inotuzumab Ozogamicin in Combination With Rituximab (375 mg/m^2 )

  Inotuzumab ozogamicin was dose escalated (3 to 6 evaluable participants enrolled per dose cohort) during the first 28 days after the first administration of inotuzumab ozogamicin + rituximab. Enrollment at the next dose level or enrollment of additional subjects into a cohort proceeded according to the following criteria: 0 dose-limiting toxicity (DLT) by Day 28 of first dose move to higher dose, 1 participant reporting DLT but no others in cohort by Day 28 of first dose move to higher dose, greater than 2 participants reporting DLT by Day 28 of first dose stop and prior dose level considered MTD. The worldwide medical monitor and investigators reviewed all significant study drug-related toxicities to determine if the dose escalation rules were satisfied and whether the dose escalation schedule required modification.

  First 28-day cycle

• Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)

  A TEAE is any event that occurred after the first dose of study drug up to 56 days post the last dose of study drug (either rituximab or inotuzumab ozogamicin).

  Protocol reporting period of from informed consent to at least 28 days after the last dose. This outcome measure time frame: From the first dose of study drug to up to 56 days after the last dose of either study drug.

Secondary Outcomes (48)

• Percentage of Participants With Complete Response (CR), Unconfirmed CR (CRu), or Partial Response (PR)

  Approximately every 2 (during treatment) or 3 (during follow-up) to 6 months for up to 5 years from 1st dose

• Kaplan-Meier Estimates of Progression Free Survival (PFS)

  From the date of first dose of test article until the first date on which disease progression or death was documented or new anticancer start, any of which could be reported up to 5 years post last dose

• Kaplan-Meier Estimates of the Probability of Being Progression Free at 6 Months

  From the first dose to 6 months after first dose

• Kaplan-Meier Estimates of Overall Survival (OS)

  From the first dose up to 5 years post last dose

• Kaplan-Meier Estimates of the Probability of Survival at 6 Months

  From the first dose to 6 months after first dose.

Study Arms (3)

INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (FOLLICULAR)

EXPERIMENTAL

Follicular

Drug: inotuzumab ozogamicin; Drug: Rituximab

INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (DLBCL)

EXPERIMENTAL

Diffuse Large B-cell Lymphoma

Drug: inotuzumab ozogamicin; Drug: Rituximab

INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (REFRACTORY)

EXPERIMENTAL

Refractory Aggressive NHL

Drug: inotuzumab ozogamicin; Drug: Rituximab

Interventions

inotuzumab ozogamicin DRUG

IV, 1.8 mg/m2, q4w

Also known as: CMC-544

INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (FOLLICULAR)

Rituximab DRUG

rituximab 375 mg/m\^2 via IV infusion on Day 1

INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (DLBCL); INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (FOLLICULAR); INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (REFRACTORY)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with CD20 and CD22-positive, follicular or diffuse large B-cell NHL who have not responded or progressed after 1 or 2 prior therapies; or subjects with CD20 and CD22-positive intermediate/aggressive NHL (diffuse large B-cell, mantle cell, transformed follicular or follicular grade 3b NHL) who have not responded or progressed after 1 or more prior therapies and are refractory to a previous rituximab containing therapy.
• Prior therapy must contain at least one course of rituximab therapy, as single agent or in combination.
• Measurable disease.

You may not qualify if:

• Subjects who are candidates for other potentially curative therapies.
• Subjects must not have received previous radioimmunotherapy.
• Subjects who have undergone a prior bone marrow transplantation within the last 6 months.

Sponsors & Collaborators

• Pfizer: lead
• UCB Pharma: collaborator

Study Sites (38)

University of Alabama at Birmingham-

Birmingham, Alabama, 35249 - 3300, United States

Location

IDS Pharmacy

Birmingham, Alabama, 35249, United States

Location

University of Alabama at Birmingham-

Birmingham, Alabama, 35294, United States

Location

California Cancer Care, Inc.

Greenbrae, California, 94904, United States

Location

University of California Medical Center

San Francisco, California, 94143, United States

Location

California Cancer Care

San Mateo, California, 94402, United States

Location

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Emory University Investigational Drug Service

Atlanta, Georgia, 30322, United States

Location

Northwestern Medical Faculty Foundation

Chicago, Illinois, 60611, United States

Location

Nevada Cancer Institute-

Las Vegas, Nevada, 89135, United States

Location

Rosewell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Gabrail Cancer Center

Dover, Ohio, 44622, United States

Location

UHHS - Westlake

Westlake, Ohio, 44145, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Royal Brisbane and Women's Hospital

Herston, Brisbane, QLD, 4029, Australia

Location

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, Vlaams-brabant, 3000, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

University Hospital Gent - Department of Hematology

Ghent, 9000, Belgium

Location

Hôpital André MIGNOT

Le Chesnay, 78157, France

Location

Hôpital Saint-Louis

Paris, 75010, France

Location

CH Lyon Sud

Pierre-Bénite, 69495, France

Location

Universitaetsklinik Bonn, Medizinische Klinik und Poliklinik III

Bonn, 53105, Germany

Location

Universitaetsmedizin der Johannes Gutenberg-Universitaet, III. medizinische klinik und Poliklinik

Mainz, 55131, Germany

Location

Prince Of Wales Hospital

Shatin N.T., HONG KONG, Hong Kong

Location

Universita La Sapienza Cattedra di Ematologia

Roma, 00161, Italy

Location

Erasmus Medisch Centrum--

Rotterdam, South Holland, 3015 CE, Netherlands

Location

Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie

Warsaw, 02-781, Poland

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Hospital Clinic I Provincial de Barcelona

Barcelona, 08028, Spain

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Derriford Hospital - Plymouth

Plymouth, Devon, PL6 8DH, United Kingdom

Location

Somers Cancer Science Building MP824

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Bart's Cancer Institute; Queen Mary University of London

London, EC1M 6BQ, United Kingdom

Location

Related Publications (1)

• Fayad L, Offner F, Smith MR, Verhoef G, Johnson P, Kaufman JL, Rohatiner A, Advani A, Foran J, Hess G, Coiffier B, Czuczman M, Gine E, Durrant S, Kneissl M, Luu KT, Hua SY, Boni J, Vandendries E, Dang NH. Safety and clinical activity of a combination therapy comprising two antibody-based targeting agents for the treatment of non-Hodgkin lymphoma: results of a phase I/II study evaluating the immunoconjugate inotuzumab ozogamicin with rituximab. J Clin Oncol. 2013 Feb 10;31(5):573-83. doi: 10.1200/JCO.2012.42.7211. Epub 2013 Jan 7.

  PMID: 23295790 DERIVED

Related Links

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

MeSH Terms

Conditions

Lymphoma, B-Cell; Lymphoma

Interventions

Inotuzumab Ozogamicin; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Calicheamicins; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Murine-Derived

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2006
• First Posted: March 6, 2006
• Study Start: May 4, 2006
• Primary Completion: May 19, 2014
• Study Completion: June 2, 2014
• Last Updated: March 8, 2018
• Results First Posted: March 8, 2018

Record last verified: 2018-02

Locations

AU (1); IT (1); CH (1); DE (2); FR (3); HK (1); US (19); NL (1); BE (3); PL (1); KR (1); ES (1); GB (3)