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

Lymphoma, B-Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717925
• Other study ID #: 3129K1-103
• Status: Completed
• Phase: Phase 1
• First received: July 16, 2008
• Last updated: December 7, 2015
• Start date: March 2007
• Est. completion date: July 2008

Study information

• Verified date: December 2015
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• Inotuzumab Ozogamicin (CMC-544)
Intravenous (IV) infusion, 1.3 - 1.8 mg/m2, every 28 days, 4 cycles

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events, dose-limiting toxicities, and changes in laboratory test results.		4 months	No
Secondary	Tumor response (according to the International Response Criteria for Non-Hodgkin's Lymphomas).		4 months	No

External Links

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