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

This study has been completed.
Sponsor:
Collaborator:
Biogen Idec
Information provided by:
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193440
First received: September 12, 2005
Last updated: December 29, 2010
Last verified: December 2010
  Purpose

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 Intervention Phase
Non-Hodgkins Lymphoma
Drug: Rituximab
Drug: CHOP
Drug: CVP
Drug: Ibritumomab Tiuxetan
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • Overall clinical response rate
  • Overall molecular response rate

Secondary Outcome Measures:
  • Progression-free survival
  • Overall survival
  • Overall toxicity

Estimated Enrollment: 40
Study Start Date: April 2002
Study Completion Date: January 2009
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193440

Sponsors and Collaborators
SCRI Development Innovations, LLC
Biogen Idec
Investigators
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00193440     History of Changes
Other Study ID Numbers: SCRI LYM 22, 106-PO69
Study First Received: September 12, 2005
Last Updated: December 29, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Antibodies, Monoclonal
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014