Rituximab and Chemotherapy Followed by Ibritumomab Tiuxetan as Treatment for Low Grade Follicular Non-Hodgkin's Lymphoma

SCRI Development Innovations

Status and phase

Completed

Phase 2

Conditions

Non-Hodgkins Lymphoma

Treatments

Drug: Rituximab

Drug: CVP

Drug: Ibritumomab Tiuxetan

Drug: CHOP

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00193440

SCRI LYM 22

106-PO69

Details and patient eligibility

About

In this trial, we will evaluate the feasibility, toxicity, and effectiveness ibritumomab tiuxetan, when incorporated into combination first-line treatment for follicular lymphoma. Addition of the ibritumomab tiuxetan to our previously evaluated, well tolerated combination of rituximab and short course chemotherapy will allow the use of additional active agent with a unique mechanism of cytotoxicity. In addition, "debulking" of lymphoma prior to 90Y Zevalin administration may minimize the myelotoxicity of this agent.

Full description

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)

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.