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

Non-Hodgkins Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193440
• Other study ID #: SCRI LYM 22
• Secondary ID: 106-PO69
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: December 29, 2010
• Start date: April 2002
• Est. completion date: January 2009

Study information

• Verified date: December 2010
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2009
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Rituximab

• CHOP

• CVP

• Ibritumomab Tiuxetan

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Biogen

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall clinical response rate
Primary	Overall molecular response rate
Secondary	Progression-free survival
Secondary	Overall survival
Secondary	Overall toxicity