Study Evaluating Inotuzumab Ozogamicin (CMC-544) In Indolent Non-Hodgkins Lymphoma

Pfizer

Status and phase: Completed; Phase 2

Conditions: Lymphoma

Treatments: Drug: Inotuzumab Ozogamicin (CMC-544)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00868608

B1931007 (Other Identifier)

2008-001635-34 (EudraCT Number)

3129K7-2001

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin (CMC-544) in subjects with indolent Non-Hodgkins lymphoma (NHL) that is refractory or has relapsed after multiple therapies including rituximab or radioimmunotherapy. The investigational drug will be given to subjects with indolent NHL by intravenous infusion at a dose of 1.8 mg/m2, every 4 weeks.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone, or small lymphocytic lymphoma) that has progressed after 2 or more prior systemic therapies.
• Previous anticancer treatment given must have contained rituximab and chemotherapy, or anti CD20 Radio Immuno Therapy. Subjects must have exhibited no response or have progressed within 6 months from the completion of the most recent rituximab or rituximab containing therapy or within 12 months of the completion of Radio Immuno Therapy.
• Measurable disease with adequate bone marrow function, renal and hepatic function

Exclusion criteria

• History of, or suggestive of, veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS) or history of chronic liver disease (eg, cirrhosis) or suspected alcohol abuse.
• Prior allogeneic hematopoietic stem cell transplant (HSCT).
• Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3b follicular lymphoma.

Trial design

81 participants in 1 patient group

inotuzumab ozogamicin

Experimental group

Description:

inotuzumab ozogamicin

Treatment:

Drug: Inotuzumab Ozogamicin (CMC-544)