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

Non-Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00177554
• Other study ID #: UPCI #03-005
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: May 27, 2008
• Start date: November 2003
• Est. completion date: May 2007

Study information

• Verified date: May 2008
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular
• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma

Intervention

Drug:
• Chemotherapy and Radioimmunotherapy
CHOP-R x 3 cycles followed by zevalin and extended rituximab

Locations

Country	Name	City	State
United States	UPMC Cancer Centers	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate		May 2007,May 2008, May2009, May 2010	No
Secondary	PET-CT conversion rate		May2007	No
Secondary	Frequency and severity of adverse events		May 2007	Yes
Secondary	Duration of complete response		May 2007,May 2008, May 2009, May 2010	No
Secondary	Time to next lymphoma therapy		May 2207,May2008,May2009, May2010	No