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Phase II Trial of Rituximab and Short Duration Chemotherapy Followed by Zevalin as First-Line Treatment for Patients With Low Grade Follicular Non-Hodgkin's Lymphoma


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

Thank you

Trial Information

Phase II Trial of Rituximab and Short Duration Chemotherapy Followed by Zevalin as First-Line Treatment for Patients With Low Grade Follicular Non-Hodgkin's Lymphoma


Upon determination of eligibility, patients will be receive:

- Rituxan + CHOP or CVP + Ibritumomab Tiuxetan

Patients who are considered medical candidates for doxorubicin should receive CHOP
chemotherapy (Cyclophosphamide, doxorubicin, vincristine and prednisone). Patients who are
not considered medical candidates for doxorubicin should receive CVP chemotherapy
(Cyclophosphamide, Vincristine, and prednisone)


Inclusion Criteria:



To be included in this study, you must meet the following criteria:

- Histologic documentation of follicular center, B-cell lymphoma

- Early stage lymphoma (stages I or II) relapsed after radiation therapy alone

- No previous chemotherapy or monoclonal antibody therapy

- Measurable or evaluable disease

- Able to perform activities of daily living with minimal assistance

- Age > 18 years

- Adequate bone marrow ,liver and kidney function

- Must be accessible for treatment and follow-up.

- Bone marrow examination initial staging and accurate restaging

- All patients must give written informed consent prior to study entry.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

- Small lymphocytic (CLL type) lymphomas and CLL

- Impaired bone marrow reserve

- Female pregnant or lactating

- Serious active infection at the time of treatment

- Any other serious underlying condition

- Central nervous system involvement (brain or meningeal)

- HIV or AIDS-related lymphoma

- Received prior external beam radiation therapy to > 25% of active bone marrow

- Pleural effusion

- Received prior murine antibodies or proteins

- History of other neoplasms within five years of diagnosis

Please note: There are additional inclusion/exclusion criteria. The study center will
determine if you meet all of the criteria. If you do not qualify for the trial, study
personnel will explain the reasons. If you do qualify, study personnel will explain the
trial in detail and answer any questions you may have.

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:

Overall clinical response rate

Principal Investigator

John D. Hainsworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI LYM 22

NCT ID:

NCT00193440

Start Date:

April 2002

Completion Date:

January 2009

Related Keywords:

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

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