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Study Evaluating Safety and Tolerability of Inotuzumab Ozogamicin (CMC-544) in Japanese Patients With B-cell Non-Hodgkin's Lymphoma (NHL)

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ClinicalTrials.gov Identifier: NCT00717925
Recruitment Status : Completed
First Posted : July 18, 2008
Last Update Posted : December 9, 2015
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Study Description
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Brief Summary:
To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544) in patients with B-Cell Non-Hodgkin's Lymphoma (NHL).

Condition or disease Intervention/treatment Phase
Lymphoma, B-Cell Drug: Inotuzumab Ozogamicin (CMC-544) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study Of CMC-544 Administered As A Single Agent In Subjects With B-Cell Non-Hodgkin's Lymphoma
Study Start Date : March 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: Inotuzumab Ozogamicin (CMC-544)
Intravenous (IV) infusion, 1.3 - 1.8 mg/m2, every 28 days, 4 cycles


Outcome Measures
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Primary Outcome Measures :
  1. Incidence and severity of adverse events, dose-limiting toxicities, and changes in laboratory test results. [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Tumor response (according to the International Response Criteria for Non-Hodgkin's Lymphomas). [ Time Frame: 4 months ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CD22-positive, B-cell NHL which has progressed after 1 or 2 prior therapies.
  • Patients who have progressed after at least 1 prior chemotherapy regimen for indolent lymphoma, or 1/ 2 chemotherapy regimens, which include anthracylin or anthraquinon for aggressive lymphoma.
  • Eastern Cooperative Oncology Group (ECOG) performance status: 0/ 1.

Exclusion Criteria:

  • Patients must not have received monoclonal antibodies or radioimmunoconjugates within 3 months before first dose of test article.
  • Patients must not have received bilateral pelvic irradiation.
  • Patients must not have received chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational agents within 4 weeks before first dose of test article.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717925


Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00717925    
Other Study ID Numbers: 3129K1-103
First Posted: July 18, 2008    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: December 2015
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
B-cell Non-Hodgkin's Lymphoma
NHL
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Inotuzumab Ozogamicin
Antineoplastic Agents