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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin Lymphoma

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Complete response rate

Outcome Time Frame:

May 2007,May 2008, May2009, May 2010

Safety Issue:

No

Principal Investigator

Samuel A Jacobs, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Food and Drug Administration

Study ID:

UPCI #03-005

NCT ID:

NCT00177554

Start Date:

November 2003

Completion Date:

May 2007

Related Keywords:

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

Name

Location

UPMC Cancer CentersPittsburgh, Pennsylvania  15232