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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)

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00717925
First received: July 16, 2008
Last updated: September 7, 2010
Last verified: September 2010
History of Changes
  Purpose

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 Intervention Phase
Lymphoma, B-Cell
 Drug: Inotuzumab Ozogamicin (CMC-544)
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Incidence and severity of adverse events, dose-limiting toxicities, and changes in laboratory test results. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor response (according to the International Response Criteria for Non-Hodgkin's Lymphomas). [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: March 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Inotuzumab Ozogamicin (CMC-544)
Intravenous (IV) infusion, 1.3 - 1.8 mg/m2, every 28 days, 4 cycles

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717925

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

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

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

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00717925     History of Changes
Other Study ID Numbers: 3129K1-103
Study First Received: July 16, 2008
Last Updated: September 7, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
B-cell Non-Hodgkin's Lymphoma
NHL

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013