At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 51 enrolled
Drug / intervention
ixabepilonedrug
Likely dose
Ixabepilone given intravenouslyAI-extracted
Key inclusion· 6
- ✓Histologically confirmed aggressive non-Hodgkin's lymphoma: Grade III follicular, DLBCL, mantle cell, primary mediastinal B-cell, Burkitt, high-grade B-cell (Burkitt-like), or CD30+ anaplastic large cell lymphoma
- ✓Relapsed or refractory disease after prior standard chemotherapy: either CR/PR lasting ≥4 weeks after most recent prior therapy (chemosensitive), or stable disease/PR but no progressive disease (refractory)
- ✓At least one bidimensionally measurable lesion ≥10 mm by conventional imaging or clinical exam
- ✓ECOG performance status 0-2
Key exclusion· 6
- ✕Known CNS involvement by lymphoma (except prior successfully treated disease with relapse exclusively outside CNS)
- ✕Prior allergic reaction or hypersensitivity to Cremophor EL or compounds of similar chemical or biological composition to BMS-247550
- ✕Peripheral neuropathy grade 2 or greater
- ✕Symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Epothilone B Analog BMS-247550 (NSC 710428) in Patients With Relapsed Aggressive Non-Hodgkin's Lymphomas
In Brief
A Phase 2 clinical trial evaluating ixabepilone for Anaplastic Large Cell Lymphoma and 5 related conditions. Completed, enrolled 51 participants across 2 sites.
Detailed Summary
This phase II trial is studying how well ixabepilone works in treating patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop cancer cells from dividing so they stop growing or die.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnaplastic Large Cell Lymphoma, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2003
First PostedApr 2003
Primary CompletionAug 2010
TodayJul 2026
First PostedApr 9, 2003
Enrollment StartFeb 1, 2003
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 23.2 years ago
Interventions
ixabepilonedrug
Given IV