Skip to main content
OpenTrials
Completed

NCT Number: NCT00717925

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inotuzumab Ozogamicin (CMC-544)

Drug

Intravenous (IV) infusion, 1.3 - 1.8 mg/m2, every 28 days, 4 cycles

Primary outcomes

  1. Incidence and severity of adverse events, dose-limiting toxicities, and changes in laboratory test results.

    Time frame: 4 months

Secondary outcomes

  1. Tumor response (according to the International Response Criteria for Non-Hodgkin's Lymphomas).

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Phase 1 Study Of CMC-544 Administered As A Single Agent In Subjects With B-Cell Non-Hodgkin's Lymphoma

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 18, 2008
Registry last updated
Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.