At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 67 enrolled
Drug / intervention
Aplidin®drug
Likely dose
Aplidin® 3.2 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Multicenter, Open-Label, Clinical And Pharmacokinetic Study of Aplidin® As A 1-Hour Weekly IV Infusion, in Patients With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma
In Brief
A Phase 2 clinical trial evaluating Aplidin® for Leukemia and Lymphoma. Completed, enrolled 67 participants across 12 sites in 6 countries.
Detailed Summary
This is a multicenter study to assess the anti-tumour activity,to investigate the safety profile and to obtain additional pharmacokinetic information for Aplidin® given as 1-hour weekly IV infusion in patients with aggressive non-Hodgkin's Lymphoma.
Study Details
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2004
First PostedApr 2009
Primary CompletionJun 2010
TodayJul 2026
First PostedApr 20, 2009
Enrollment StartDec 1, 2004
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 17.2 years ago
Interventions
Aplidin®drug
Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.