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NCT00290511 · ClinicalTrials.gov registry record · Phase 2
Rituximab, Fludarabine, Mitoxantrone, Dexamethasone (R-FND) Plus Zevalin for High-Risk Follicular Lymphoma
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT00290511: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00290511 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 49 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00290511, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if chemotherapy given with rituximab, followed by Ibritumomab tiuxetan (Zevalin), and then followed by rituximab can help to control lymphoma. The safety of this treatment schedule will also be studied. Objectives: 1. To assess whether the time to progression for these high-risk patients can be prolonged to a median of 36 months, compared to the historical expectation of approximately 24 months. 2. To assess the tolerance and efficacy of Y2B8 (Zevalin) after R-FND (rituximab, fludarabine, mitoxantrone, dexamethasone) in patients with high-risk stage III-IV follicular lymphoma 3. To assess overall response, failure-free survival, and survival of this strategy compared to our historical experience with FND (fludarabine, mitoxantrone, dexamethasone) alone or R-FND 4. To assess the tolerance and efficacy of maintenance therapy with rituximab. 5. To maximize the 12-month molecular remission rate for patients with high-risk stage III-IV follicular lymphoma 6. to correlate the results of quantitative PCR assay with classical PCR and with clinical outcome
Interventions
- DRUG Fludarabine
- DRUG Rituximab
- DRUG Dexamethasone
- DRUG Mitoxantrone
- DRUG Zevalin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2004-06-29 |
| Est. Completion | 2021-02-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00290511
The ClinicalTrials.gov registry entry for NCT00290511 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.
NCT00290511 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00290511 about?
NCT00290511 is a clinical study titled "Rituximab, Fludarabine, Mitoxantrone, Dexamethasone (R-FND) Plus Zevalin for High-Risk Follicular Lymphoma". The goal of this clinical research study is to learn if chemotherapy given with rituximab, followed by Ibritumomab tiuxetan (Zevalin), and then followed by rituximab can help to control lymphoma. The safety of this treatment schedule will also be studied. Objectives: 1. To assess whether the time ...
What is the current status of trial NCT00290511?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2004-06-29. Estimated completion is 2021-02-12.
What interventions are being tested in trial NCT00290511?
The interventions under investigation include: Fludarabine (DRUG), Rituximab (DRUG), Dexamethasone (DRUG), Mitoxantrone (DRUG), Zevalin (DRUG).
Who is sponsoring clinical trial NCT00290511?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.