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

Sponsor
SCRI Development Innovations, LLC (Other)
Overall Status
Completed
CT.gov ID
NCT00193440
Collaborator
Biogen (Industry)
40
Enrollment
81.1
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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)

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Apr 1, 2002
Actual Primary Completion Date :
Apr 1, 2004
Actual Study Completion Date :
Jan 1, 2009

Outcome Measures

Primary Outcome Measures

  1. Overall clinical response rate []

  2. Overall molecular response rate []

Secondary Outcome Measures

  1. Progression-free survival []

  2. Overall survival []

  3. Overall toxicity []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • SCRI Development Innovations, LLC
  • Biogen

Investigators

  • Principal Investigator: John D. Hainsworth, MD, SCRI Development Innovations, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00193440
Other Study ID Numbers:
  • SCRI LYM 22
  • 106-PO69
First Posted:
Sep 19, 2005
Last Update Posted:
Dec 30, 2010
Last Verified:
Dec 1, 2010
Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Follicular
Rituximab

Study Results

No Results Posted as of Dec 30, 2010