Study Evaluating Inotuzumab Ozogamicin [CMC-544] Administered In Combination With Rituximab In Subjects With Non-Hodgkin's Lymphoma (NHL)

Pfizer

Status and phase: Completed; Phase 2; Phase 1

Conditions: B-Cell Lymphoma

Treatments: Drug: inotuzumab ozogamicin; Drug: Rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00299494

B1931004 (Other Identifier)

2005-005436-27 (EudraCT Number)

3129K3-101

Details and patient eligibility

About

The purpose of the study is to determine the tolerability, the initial safety profile and maximum tolerated dose, and to obtain preliminary information on the antitumor activity of inotuzumab ozogamicin [CMC-544] in combination with rituximab in subjects with follicular, diffuse large B-Cell, or mantle cell NHL.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with CD20 and CD22-positive, follicular or diffuse large B-cell NHL who have not responded or progressed after 1 or 2 prior therapies; or subjects with CD20 and CD22-positive intermediate/aggressive NHL (diffuse large B-cell, mantle cell, transformed follicular or follicular grade 3b NHL) who have not responded or progressed after 1 or more prior therapies and are refractory to a previous rituximab containing therapy.
• Prior therapy must contain at least one course of rituximab therapy, as single agent or in combination.
• Measurable disease.

Exclusion criteria

• Subjects who are candidates for other potentially curative therapies.
• Subjects must not have received previous radioimmunotherapy.
• Subjects who have undergone a prior bone marrow transplantation within the last 6 months.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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119 participants in 3 patient groups

INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (FOLLICULAR)

Experimental group

Description:

Follicular

Treatment:

Drug: Rituximab

Drug: inotuzumab ozogamicin

Drug: inotuzumab ozogamicin

Drug: inotuzumab ozogamicin

INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (DLBCL)

Experimental group

Description:

Diffuse Large B-cell Lymphoma

Treatment:

Drug: Rituximab

Drug: inotuzumab ozogamicin

Drug: inotuzumab ozogamicin

Drug: inotuzumab ozogamicin

INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (REFRACTORY)

Experimental group

Description:

Refractory Aggressive NHL

Treatment:

Drug: Rituximab

Drug: inotuzumab ozogamicin

Drug: inotuzumab ozogamicin

Drug: inotuzumab ozogamicin