Study Evaluating CMC-544 In B-Cell Non-Hodgkin's Lymphoma

Pfizer

Status and phase: Completed; Phase 1

Conditions: Lymphoma, B-Cell

Treatments: Drug: Inotuzumab ozogamicin [CMC-544]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00073749

3129K1-100

B1931002 (Other Identifier)

Details and patient eligibility

About

To determine the Maximum Tolerated Dose (MTD), the tolerability, and the initial safety profile of CMC-544 in subjects with B-cell Non-Hodgkin's Lymphoma (NHL).

Enrollment: 79 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who have been previously diagnosed with CD22-positive, B-cell NHL, according to WHO classification, which has progressed after at least 2 prior therapies of probable clinical benefit
• At the expanded cohort, part 2 of the study, subjects must have one of the following:
• Follicular lymphoma previously treated with at least one dose of rituximab, but have not received radioimmunotherapy
• Diffuse large B-cell lymphoma
• Age 18 years or older

Exclusion criteria

• Candidate for potentially curative therapies in the opinion of the investigator
• Chronic lymphocytic leukemia
• Burkitt's lymphoma, primary effusion lymphoma, and precursor B-cell lymphoblastic lymphoma

Trial design

79 participants in 1 patient group

Inotuzumab ozogamicin

Experimental group

Description:

Inotuzumab ozogamicin, iv, dose escalation and expanded cohort at 1.8mg/m2

Treatment:

Drug: Inotuzumab ozogamicin [CMC-544]