At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 29 enrolled
Drug / intervention
Ofatumumabdrug
Likely dose
Ofatumumab 300 mgfrom 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 Single-arm, International, Multi-center Trial Investigating the Efficacy and Safety of Ofatumumab Retreatment and Maintenance in CLL Patients Who Progressed Following Response or Stable Disease After Ofatumumab Treatment in Hx-CD20-406
In Brief
A Phase 4 clinical trial evaluating Ofatumumab for Leukaemia, Lymphocytic, Chronic. Completed, enrolled 29 participants across 2 sites.
Detailed Summary
The purpose of the trial is to investigate the efficacy and safety of ofatumumab retreatment and maintenance in patients with chronic lymphocytic leukemia who have previously responded or had disease stabilization after ofatumumab in an ongoing trial (Hx-CD20-406).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukaemia, Lymphocytic, Chronic
CountriesSweden
CollaboratorsGenmab
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2008
Enrollment StartJan 2009
Primary CompletionSep 2011
Study CompletionMay 2013
TodayJul 2026
First PostedDec 5, 2008
Enrollment StartJan 1, 2009
Primary CompletionSep 1, 2011
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.6 years ago
Interventions
Ofatumumabdrug
Eight once weekly infusions (1 x 300 mg + 7 x 2000 mg), then 2000 mg once monthly for two years