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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
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
CHOP
DrugCVP
DrugIbritumomab tiuxetan
DrugPrimary outcomes
-
Overall clinical response rate
-
Overall molecular response rate
Secondary outcomes
-
Progression-free survival
-
Overall survival
-
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.
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