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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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower). 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
Primary Outcome
Regimen regarded as a success if median TTP can be prolonged to 36 months or greater. Time to Progression measured by the method of Kaplan and Meier, and accompanied by 95% confidence interval. Complete Response (CR) defined as those who achieve a normal state which includes no detectable evidence of disease on x-rays and Partial Response (PR) is defined as a 50% or more reduction in the sum of the products of the diameters of the 6 largest measurable lesions. No new sites of disease. av
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 |
What the finished NCT00290511 record still lists
NCT00290511 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.
NCT00290511 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00290511's enrollment target sits among peer trials
49 1261st of 2000 higher than 736 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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