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

Status:	Completed
Conditions:	Lymphoma
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/17/2018
Start Date:	May 4, 2006
End Date:	June 2, 2014

A Phase 1/2 Study Of Cmc-544 Administered In Combination With Rituximab In Subjects With Follicular Or Diffuse Large B-cell Non-hodgkin's Lymphoma

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.

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.

We found this trial at

sites

Emory University Investigational Drug Service

Atlanta, Georgia 30322

from

Atlanta, GA