CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 66 enrolled
Drug / intervention
Blinatumomabdrug
Likely dose
Not stated in 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/NCT02412306
NCT02412306Phase 2Completed
CompareCT.gov

A Phase 1b/2 Study of Blinatumomab in Japanese Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (Horai Study)

Amgen·interventional·Posted Apr 9, 2015·Updated Dec 12, 2022

In Brief

A Phase 2 clinical trial evaluating Blinatumomab for Relapsed Refractory B Precursor Acute Lymphoblastic Leukemia. Completed, enrolled 66 participants across 16 sites.

Detailed Summary

This is an open-label, combined 2-part multicenter study to evaluate the efficacy, safety, and tolerability of blinatumomab in adult and pediatric Japanese patients with relapsed/refractory B-precursor ALL.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsed Refractory B Precursor Acute Lymphoblastic Leukemia
CountriesJapan
CollaboratorsAmgen Astellas Biopharma K.K.

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 9, 2015
Enrollment StartJun 4, 2015
Primary CompletionFeb 6, 2019
Study CompletionJul 4, 2019
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 11.2 years ago

Interventions

Blinatumomabdrug

Continuous intravenous infusion over four weeks per treatment cycle