Study Evaluating CMC-544 Administered In Combination With Rituximab In Subjects With Non-Hodgkin's Lymphoma (NHL) - Full Text View

Sponsor:	Pfizer
Collaborator:	UCB, Inc.
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00299494

Purpose

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 CMC-544 in combination with rituximab in subjects with follicular, diffuse large B-Cell, or mantle cell NHL.

Condition	Intervention	Phase
Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Follicular	Drug: inotuzumab ozogamicin	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Rituximab Inotuzumab ozogamicin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Determination of MTD and safety as measured by the incidence of AEs [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Objective response rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
Progression free survival at 6 months [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
Overall survival data [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
Pharmacokinetic and pharmacodynamic measures of inotuzumab ozogamicin given in combination with rituximab [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	May 2006
Estimated Study Completion Date:	May 2014
Estimated Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Follicular	Drug: inotuzumab ozogamicin iv, 1.8 mg/m2, q4w
Experimental: 2 Diffuse Large B-cell Lymphoma	Drug: inotuzumab ozogamicin iv, 1.8 mg/m2, q4w
Experimental: 3 Refractory Aggressive NHL	Drug: inotuzumab ozogamicin iv, 1.8 mg/m2, q4w

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299494

Show 36 Study Locations

Sponsors and Collaborators

Pfizer

UCB, Inc.

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00299494 History of Changes
Other Study ID Numbers:	3129K3-101, B1931004
Study First Received:	March 2, 2006
Last Updated:	January 12, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Lymphoma
NHL

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases

Immunoproliferative Disorders
Immune System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012