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

September 12, 2005
December 29, 2010
April 2002
April 2004   (final data collection date for primary outcome measure)
  • Overall clinical response rate
  • Overall molecular response rate
Same as current
Complete list of historical versions of study NCT00193440 on ClinicalTrials.gov Archive Site
  • Progression-free survival
  • Overall survival
  • Overall toxicity
Same as current
Not Provided
Not Provided
 
Rituximab and Chemotherapy Followed by Ibritumomab Tiuxetan as Treatment for Low Grade Follicular Non-Hodgkin's Lymphoma
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

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.

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)

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Hodgkins Lymphoma
  • Drug: Rituximab
  • Drug: CHOP
  • Drug: CVP
  • Drug: Ibritumomab Tiuxetan
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2009
April 2004   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00193440
SCRI LYM 22, 106-PO69
Not Provided
Not Provided
SCRI Development Innovations, LLC
Biogen Idec
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP