NCT00193440

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2002

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

December 30, 2010

Status Verified

December 1, 2010

Enrollment Period

2 years

First QC Date

September 12, 2005

Last Update Submit

December 29, 2010

Conditions

Non-Hodgkins Lymphoma

Outcome Measures

Primary Outcomes (2)

  • Overall clinical response rate

  • Overall molecular response rate

Secondary Outcomes (3)

  • Progression-free survival

  • Overall survival

  • Overall toxicity

Interventions

RituximabDRUG
CHOPDRUG
CVPDRUG
Ibritumomab TiuxetanDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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 phase II trial of the Sarah Cannon Oncology Research Consortium. Clin Lymphoma Myeloma. 2009 Jun;9(3):223-8. doi: 10.3816/CLM.2009.n.044.

    PMID: 19525191RESULT

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Rituximabibritumomab tiuxetan

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • John D. Hainsworth, MD

    SCRI Development Innovations, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

April 1, 2002

Primary Completion

April 1, 2004

Study Completion

January 1, 2009

Last Updated

December 30, 2010

Record last verified: 2010-12