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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00177554
Other study ID # UPCI #03-005
Secondary ID
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


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
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