At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
MEDI-551drug
Likely dose
MEDI-551 8 mg/kgfrom 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 1, Dose-escalation Study of MEDI-551, a Humanized Monoclonal Antibody Directed Against CD19, in Japanese Adult Patients With Relapsed or Refractory Advanced B-cell Malignancies
In Brief
A Phase 1 clinical trial evaluating MEDI-551 for Blood Cancer and Advanced B Cell Malignancies. Completed, enrolled 32 participants across 3 sites.
Detailed Summary
The primary objective of this study is to evaluate the safety and tolerability of MEDI-551 in Japanese patients with relapsed or refractory advanced B-cell malignancies.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBlood Cancer, Advanced B Cell Malignancies
CountriesJapan
CollaboratorsMedImmune LLC
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2011
First PostedOct 2013
Primary CompletionSep 2015
TodayJul 2026
First PostedOct 8, 2013
Enrollment StartMay 25, 2011
Primary CompletionSep 15, 2015
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 12.7 years ago
Interventions
MEDI-551drug
MEDI-551 will be administered by intravenous infusion at dose of 2, 4 or 8 mg/kg once per week on Days 1 and 8 in the first cycle and then once every 28 days at the start of each subsequent cycle