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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Lymphoma, B-Cell

Treatments: Drug: Inotuzumab Ozogamicin (CMC-544)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00717925

3129K1-103

Details and patient eligibility

About

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

Enrollment: 13 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Inotuzumab Ozogamicin (CMC-544)