CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
chlorambucil, tablets +1 moredrug
Likely dose
chlorambucil, tablets 2mgfrom 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.

Search/NCT01563055
NCT01563055Phase 2Completed
CompareCT.gov

A Phase I/II, Open-label Study of Ofatumumab Added to Chlorambucil in Previously Untreated Japanese Patients With Chronic Lymphocytic Leukemia

GlaxoSmithKline·interventional·Posted Mar 26, 2012·Updated Aug 10, 2015

In Brief

A Phase 2 clinical trial evaluating chlorambucil, tablets and ofatumumab (GSK1841157) infusion for Leukaemia, Lymphocytic, Chronic. Completed, enrolled 10 participants across 6 sites.

Detailed Summary

This is an open-label study to evaluate tolerability, safety, efficacy and pharmacokinetic profile of ofatumumab in combination with chlorambucil in Japanese patients with previously untreated Chronic Lymphocytic Leukemia (CLL).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukaemia, Lymphocytic, Chronic
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 26, 2012
Enrollment StartApr 1, 2012
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 14.3 years ago

Interventions

chlorambucil, tabletsdrug

2mg tablets, chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 cycles

ofatumumab (GSK1841157) infusiondrug

iv infusion; dose: cycle 1 300mg day 1 and 1000mg day 8, subsequent cycles: 1000mg at day 1 every 28 days;