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

NCT ID: NCT00193440

Last Updated: 2010-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2009-01-31

Brief Summary

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.

Detailed 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)

Conditions

Non-Hodgkins Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Rituximab

Intervention Type: DRUG

CHOP

Intervention Type: DRUG

CVP

Intervention Type: DRUG

Ibritumomab Tiuxetan

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role: lead

Principal Investigators

John D. Hainsworth, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

References

Hainsworth JD, Spigel DR, Markus TM, Shipley D, Thompson D, Rotman R, Dannaher C, Greco FA. Rituximab plus short-duration chemotherapy followed by Yttrium-90 Ibritumomab tiuxetan as first-line treatment for patients with follicular non-Hodgkin lymphoma: a phase II trial of the Sarah Cannon Oncology Research Consortium. Clin Lymphoma Myeloma. 2009 Jun;9(3):223-8. doi: 10.3816/CLM.2009.n.044.

Reference Type: RESULT

PMID: 19525191 (View on PubMed)

Other Identifiers

106-PO69

Identifier Type: -

Identifier Source: secondary_id

SCRI LYM 22

Identifier Type: -

Identifier Source: org_study_id