At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 5 enrolled
Drug / intervention
chlorambucil, tabletsdrug
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.
A Phase II, Open Label, Single Arm, Multicenter Study of Chlorambucil in Japanese Previously Untreated Patients With Chronic Lymphocytic Leukemia
In Brief
A Phase 2 clinical trial evaluating chlorambucil, tablets for Leukaemia, Lymphoblastic. Completed, enrolled 5 participants across 6 sites.
Detailed Summary
This study is an open-label, single arm, phase II study of chlorambucil in subjects with previously untreated CLL. The primary objective is to evaluate the response to chlorambucil in Japanese subjects with previously untreated CLL. Secondary objectives are to evaluate efficacy, safety and pharmacokinetics of chlorambucil in Japanese subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukaemia, Lymphoblastic
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 2013
Enrollment StartApr 2013
Primary CompletionNov 2014
TodayJul 2026
First PostedMar 11, 2013
Enrollment StartApr 1, 2013
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 13.3 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