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

Primary Purpose

Non-Hodgkin Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Chemotherapy and Radioimmunotherapy
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin Lymphoma focused on measuring Non-Hodgkin Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UPMC Cancer Centers

Outcomes

Primary Outcome Measures

Complete response rate

Secondary Outcome Measures

PET-CT conversion rate
Frequency and severity of adverse events
Duration of complete response
Time to next lymphoma therapy

Full Information

First Posted
September 13, 2005
Last Updated
May 27, 2008
Sponsor
University of Pittsburgh
Collaborators
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT00177554
Brief Title
Phase II Trial of CHOP-R Followed by Zevalin and Rituxan in Follicular Lymphoma
Official Title
Phase II Trial of CHOP-R Followed by Zevalin and Rituxan in Follicular Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pittsburgh
Collaborators
Biogen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin Lymphoma
Keywords
Non-Hodgkin Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Chemotherapy and Radioimmunotherapy
Intervention Description
CHOP-R x 3 cycles followed by zevalin and extended rituximab
Primary Outcome Measure Information:
Title
Complete response rate
Time Frame
May 2007,May 2008, May2009, May 2010
Secondary Outcome Measure Information:
Title
PET-CT conversion rate
Time Frame
May2007
Title
Frequency and severity of adverse events
Time Frame
May 2007
Title
Duration of complete response
Time Frame
May 2007,May 2008, May 2009, May 2010
Title
Time to next lymphoma therapy
Time Frame
May 2207,May2008,May2009, May2010

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel A Jacobs, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Cancer Centers
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18981007
Citation
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. doi: 10.1158/1078-0432.CCR-08-0529.
Results Reference
derived

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

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