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

Wyeth is now a wholly owned subsidiary of Pfizer13 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoma, B-Cell

Interventions

Inotuzumab Ozogamicin (CMC-544)DRUG

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 74 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 4 months

Secondary Outcomes

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

Time frame: 4 months

Data from ClinicalTrials.gov

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