At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of R-FND, Followed by Zevalin Radioimmunotherapy, and Subsequent Maintenance Rituximab for Advanced Stage Follicular Lymphoma With High-Risk Features
In Brief
A Phase 2 clinical trial evaluating Fludarabine, Mitoxantrone, and 3 other interventions for Lymphoma. Completed, enrolled 49 participants across 1 site.
Detailed 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
Study Details
Timeline
Interventions
25 mg/m\^2 intravenous (IV) over 5-30 minutes on Days 2-4.
10 mg/m\^2 IV over 5-30 minutes on Day 2.
375 mg/m\^2 IV over 4-6 hours on Day 1 and 8; maintenance Rituximab = 375 mg/m\^2 IV over 4-6 hours on Day 1 only, a single dose every other month for 12 months (6 doses total).
0.3 mCi/kg IV after 4 cycles of R-FND.
20 mg by mouth (PO) or IV daily on Days 2-6.