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

Sponsored by:	Wyeth
Information provided by:	Wyeth
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, Diffuse Lymphoma, Follicular	Drug: CMC-544 Drug: Rituximab	Phase I Phase II

MedlinePlus related topics: Lymphoma

Drug Information available for: Rituximab Inotuzumab ozogamicin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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-Hodgkinâ€™s Lymphoma.

Further study details as provided by Wyeth:

Primary Outcome Measures:

Safety and Efficacy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Objective response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Progression free survival at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Overall survival data [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	March 2006
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

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. Other inclusions apply

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 Other exclusions apply

Contacts and Locations

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

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Show 38 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For Belgium, trials-BEL@wyeth.com
Principal Investigator:	Trial Manager	For Netherlands, trials-NL@wyeth.com
Principal Investigator:	Trial Manager	For Switzerland, med@wyeth.com
Principal Investigator:	Trial Manager	For France, infomedfrance@wyeth.com
Principal Investigator:	Trial Manager	For Italy, decresg@wyeth.com
Principal Investigator:	Trial Manager	For Germany, medinfoDEU@wyeth.com
Principal Investigator:	Trial Manager	For United Kingdom, ukmedinfo@wyeth.com
Principal Investigator:	Trial Manager	For Spain, infomed@wyeth.com
Principal Investigator:	Trial Manager	For Poland, WPWZMED@wyeth.com

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3129K3-101
Study First Received:	March 2, 2006
Last Updated:	July 22, 2008
ClinicalTrials.gov Identifier:	NCT00299494
Health Authority:	Australia: Human Research Ethics Committee; Australia: National Health and Medical Research Council; Belgium: Institutional Review Board; France: Institutional Ethical Committee; Germany: Ethics Commission; Hong Kong: Department of Health; Hong Kong: Ethics Committee; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Netherlands: Independent Ethics Committee; Poland: Ministry of Health; Singapore: Clinical Trials & Epidemiology Research Unit (CTERU); South Korea: Korea Food and Drug Administration (KFDA); Spain: Ministry of Health; United Kingdom: Department of Health; United Kingdom: Research Ethics Committee; United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Wyeth:

Lymphoma

Study placed in the following topic categories:

Lymphoma, B-Cell
Lymphatic Diseases
Immunoproliferative Disorders
Rituximab
B-cell lymphomas
Lymphoma, small cleaved-cell, diffuse

Lymphoma, Follicular
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Follicular lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009