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CompletedNCT00193440Updated Dec 30, 2010

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

A Phase 2 interventional study of Rituximab and CHOP in Non-Hodgkins Lymphoma, sponsored by SCRI Development Innovations, LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-12-30.

Sponsored by SCRI Development Innovations, LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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)

02

Conditions studied

03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 40 is close to the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

SCRI Development Innovations, LLC is the lead sponsor of 174 studies on the registry; 5 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 15 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants

Interventions

  • DrugRituximab
  • DrugCHOP
  • DrugCVP
  • DrugIbritumomab Tiuxetan
06

What researchers measure

Primary outcomes

  1. Overall clinical response rate

  2. Overall molecular response rate

Secondary outcomes

  1. Progression-free survival

  2. Overall survival

  3. Overall toxicity

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 19525191 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00193440
Lead sponsor
SCRI Development Innovations, LLC
Collaborators
Biogen
First posted
Sep 19, 2005
Start date
Apr 2002
Primary completion
Apr 2004
Completion
Jan 2009
Last update
Dec 30, 2010

Study contacts

John D. Hainsworth, MD
principal investigator · SCRI Development Innovations, LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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