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

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT00177554
• Collaborator: Biogen (Industry)
• Enrollment: 60
• Location: 1
• Duration (Months): 42
• Patients Per Site Per Month: 1.4

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin Lymphoma	Drug: Chemotherapy and Radioimmunotherapy	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of CHOP-R Followed by Zevalin and Rituxan in Follicular Lymphoma
• Study Start Date: Nov 1, 2003
• Actual Primary Completion Date: May 1, 2007
• Actual Study Completion Date: May 1, 2007

Outcome Measures

Primary Outcome Measures

1. Complete response rate [May 2007,May 2008, May2009, May 2010]

Secondary Outcome Measures

1. PET-CT conversion rate [May2007]

2. Frequency and severity of adverse events [May 2007]

3. Duration of complete response [May 2007,May 2008, May 2009, May 2010]

4. Time to next lymphoma therapy [May 2207,May2008,May2009, May2010]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	UPMC Cancer Centers	Pittsburgh	Pennsylvania	United States	15232

Sponsors and Collaborators

• University of Pittsburgh
• Biogen

Investigators

• Principal Investigator: Samuel A Jacobs, MD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00177554
• Other Study ID Numbers: UPCI #03-005
• First Posted: Sep 15, 2005
• Last Update Posted: May 29, 2008
• Last Verified: May 1, 2008

• Keywords provided by , ,: Non-Hodgkin Lymphoma
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Follicular; Lymphoma, Non-Hodgkin

Study Results

No Results Posted as of May 29, 2008