Phase II Trial of CHOP-R Followed by Zevalin and Rituxan in Follicular Lymphoma - Full Text View

Sponsors and Collaborators:	University of Pittsburgh Biogen Idec
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00177554

Purpose

The purpose of this study is to determine the complete response rate when CHOP-R chemotherapy in followed by Zevalin in previous untreated patients with follicular lymphoma

Condition	Intervention	Phase
Non-Hodgkin Lymphoma	Drug: Chemotherapy and Radioimmunotherapy	Phase II

MedlinePlus related topics: Lymphoma

Drug Information available for: Rituximab Ibritumomab tiuxetan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Trial of CHOP-R Followed by Zevalin and Rituxan in Follicular Lymphoma

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Complete response rate [ Time Frame: May 2007,May 2008, May2009, May 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PET-CT conversion rate [ Time Frame: May2007 ] [ Designated as safety issue: No ]
Frequency and severity of adverse events [ Time Frame: May 2007 ] [ Designated as safety issue: Yes ]
Duration of complete response [ Time Frame: May 2007,May 2008, May 2009, May 2010 ] [ Designated as safety issue: No ]
Time to next lymphoma therapy [ Time Frame: May 2207,May2008,May2009, May2010 ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	November 2003
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Intervention Details:

CHOP-R x 3 cycles followed by zevalin and extended rituximab

Detailed Description:

Patients with follicular lymphoma who require therapy and have been previously untreated are eligible for this non-randomized, phase II study evaluating up front therapy with CHOP-R x 3 cycles followed by zevalin and 4 additional weeks of rituxan.The complete response will be determined by combining IWC criteria and PET scanning.Secondary objectives include PET-CT conversion rate, frequency and severity of adverse events, duration of complete remission and time to next lymphoma therapy.

Eligibility

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

Criteria

Inclusion Criteria:

Conformed diagnosis of follicular lymphoma, grades 1,2 or 3
No prior chemotherapy
No prior monoclonal antibody therapy
Bulky or symptomatic disease, stage II-IV
Performance status 0-2

Exclusion Criteria:

Impaired bone marrow reserve
Presence of CNS lymphoma
Serious nonmalignant disease or active infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177554

Locations

United States, Pennsylvania
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232

Sponsors and Collaborators

University of Pittsburgh

Biogen Idec

Investigators

Principal Investigator:

Samuel A Jacobs, MD

UPMC Cancer Centers

More Information

Publications indexed to this study:

Jacobs SA, Swerdlow SH, Kant J, Foon KA, Jankowitz R, Land SR, DeMonaco N, Joyce J, Osborn JL, Evans TL, Schaefer PM, Luong TM. Phase II trial of short-course CHOP-R followed by 90Y-ibritumomab tiuxetan and extended rituximab in previously untreated follicular lymphoma. Clin Cancer Res. 2008 Nov 1;14(21):7088-94.

Responsible Party:	University of Pittsburgh cancer Institute ( Samuel Jacobs,MD )
Study ID Numbers:	UPCI #03-005
Study First Received:	September 13, 2005
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00177554
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:

Non-Hodgkin Lymphoma

Study placed in the following topic categories:

Lymphatic Diseases
Immunoproliferative Disorders
Rituximab
Lymphoma, small cleaved-cell, diffuse
Lymphoma, Follicular

Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Follicular lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009