Skip to main content
OpenTrials
Completed

NCT Number: NCT00193440

Rituximab and Chemotherapy Followed by Ibritumomab Tiuxetan as Treatment for 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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rituximab

Drug

CHOP

Drug

CVP

Drug

Ibritumomab tiuxetan

Drug

Primary outcomes

  1. Overall clinical response rate

  2. Overall molecular response rate

Secondary outcomes

  1. Progression-free survival

  2. Overall survival

  3. Overall toxicity

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • Biogen

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2004
Study completion
2009
First posted
Sep 19, 2005
Registry last updated
Dec 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.