Study Evaluating CMC-544 In B-Cell Non-Hodgkin's Lymphoma

NCT ID: NCT00073749

Last Updated: 2018-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2010-12-31

Brief Summary

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To determine the Maximum Tolerated Dose (MTD), the tolerability, and the initial safety profile of CMC-544 in subjects with B-cell Non-Hodgkin's Lymphoma (NHL).

Detailed Description

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Conditions

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Lymphoma, B-Cell

Keywords

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B-Cell Non-Hodgkin's Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Inotuzumab ozogamicin

Inotuzumab ozogamicin, iv, dose escalation and expanded cohort at 1.8mg/m2

Group Type EXPERIMENTAL

Inotuzumab ozogamicin [CMC-544]

Intervention Type DRUG

CMC-544, IV, dose escalation trial

Interventions

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Inotuzumab ozogamicin [CMC-544]

CMC-544, IV, dose escalation trial

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects who have been previously diagnosed with CD22-positive, B-cell NHL, according to WHO classification, which has progressed after at least 2 prior therapies of probable clinical benefit
* At the expanded cohort, part 2 of the study, subjects must have one of the following:
* Follicular lymphoma previously treated with at least one dose of rituximab, but have not received radioimmunotherapy
* Diffuse large B-cell lymphoma
* Age 18 years or older

Exclusion Criteria

* Candidate for potentially curative therapies in the opinion of the investigator
* Chronic lymphocytic leukemia
* Burkitt's lymphoma, primary effusion lymphoma, and precursor B-cell lymphoblastic lymphoma
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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UAB CCC Clinical Studies Unit

Birmingham, Alabama, United States

Site Status

University of Alabama at Birmingham Kirklin Clinic

Birmingham, Alabama, United States

Site Status

UAB Russell Ambulatory Pharmacy

Birmingham, Alabama, United States

Site Status

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Northwestern Medical Faculty Foundation

Chicago, Illinois, United States

Site Status

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status

Universitair Ziekenhuis Gasthuisberg

Leuven, , Belgium

Site Status

Hopital Saint Louis

Paris, , France

Site Status

Centre Hospitalier Lyon-Sud

Pierre-Bénite, , France

Site Status

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, Germany

Site Status

Universitaetsmedizin der Johannes Gutenberg-Universitaet

Mainz, , Germany

Site Status

Medizinische Klinik und Poliklinik III, Klinikum der Universitat Muenchen-Grosshadern

München, , Germany

Site Status

Universitaet Muenchen Klinikum Grosshadern

München, , Germany

Site Status

Hospital de la Santa Creu I Sant Pau

Barcelona, , Spain

Site Status

Hospital Clinic I Provincial

Barcelona, , Spain

Site Status

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Site Status

St Bartholomew's Hospital

London, , United Kingdom

Site Status

Countries

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United States Belgium France Germany Spain Switzerland United Kingdom

Related Links

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Other Identifiers

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B1931002

Identifier Type: OTHER

Identifier Source: secondary_id

3129K1-100

Identifier Type: -

Identifier Source: org_study_id