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NCT00574730 · ClinicalTrials.gov registry record · NA
CHOP/Rituximab Followed by Maintenance PEG Intron in Treatment of Indolent/Follicular Non-Hodgkin's Lymphoma
A NA study, sponsored by University of Nebraska.
- Completed
- Registry status
- NA
- Development phase
- 27
- Enrollment target
NCT00574730 is a NA study that has completed, run by University of Nebraska. The registered enrollment target is 27 participants.
The verdict
NCT00574730, a NA study, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- NA
- Development phase
- 27 participants
- Enrollment target
Study Summary
This study will assess the toxicity/safety of CHOP chemotherapy given concurrently with rituximab, followed by maintenance PEG Intron in patients with anthracycline naïve indolent non-Hodgkin's lymphoma. This study will also evaluate response rates, time to progression, molecular response, and immunologic parameters related to this treatment.will have an ocular exam prior to treatment. Patients in this study will receive 6 cycles of combination chemotherapy with the standard CHOP regimen given in conjunction with rituximab. Cycles are repeated at 21-day intervals for six to eight cycles. Patients achieving at least a partial response to chemotherapy will begin PEG Intron at a dose of 2g/kg/week subcutaneously. PEG Intron treatment will be continued for 12 months in the absence of signs of progressive/recurrent disease, or unacceptable toxicity/intolerance of therapy. PEG Intron dosing will be adjusted based on the presence of symptoms or other clinical manifestations of toxicity. Patients will undergo bone marrow evaluation for molecular testing at baseline. Those found to be positive will have repeat assessments performed post induction therapy, and after six months of PEG Intron. Patients will also undergo immunologic evaluation at baseline, post induction therapy, and after six months of PEG Intron. At the end of PEG Intron therapy, patients will have disease reevaluation and then annual data collection for long-term toxicity, duration of response and survival.
Interventions
- DRUG CHOP/Rituximab
- DRUG PEG INTRON
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2001-05-23 |
| Est. Completion | 2012-06-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00574730
The ClinicalTrials.gov registry entry for NCT00574730 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which CHOP/Rituximab is the first listed.
NCT00574730 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00574730 about?
NCT00574730 is a clinical study titled "CHOP/Rituximab Followed by Maintenance PEG Intron in Treatment of Indolent/Follicular Non-Hodgkin's Lymphoma". This study will assess the toxicity/safety of CHOP chemotherapy given concurrently with rituximab, followed by maintenance PEG Intron in patients with anthracycline naïve indolent non-Hodgkin's lymphoma. This study will also evaluate response rates, time to progression, molecular response, and immun...
What is the current status of trial NCT00574730?
This trial is currently completed. It is a NA study. The enrollment target is 27 participants. The study started on 2001-05-23. Estimated completion is 2012-06-07.
What interventions are being tested in trial NCT00574730?
The interventions under investigation include: CHOP/Rituximab (DRUG), PEG INTRON (DRUG).
Who is sponsoring clinical trial NCT00574730?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
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