CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 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/NCT02000427
NCT02000427Phase 2Completed

A Phase 2 Single Arm, Multicenter Trial to Evaluate the Efficacy of the BiTE Antibody Blinatumomab in Adult Subjects With Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia (Alcantara Study)

Amgen·interventional·Posted Dec 4, 2013·Updated May 28, 2024

In Brief

A Phase 2 clinical trial evaluating Blinatumomab for Relapsed/Refractory Philadelphia Positive B-precursor ALL. Completed, enrolled 45 participants across 22 sites in 5 countries.

Detailed Summary

The primary objective is to evaluate the rate of complete remission/complete remission with partial hematological recovery (CRh\*) in adults with relapsed/refractory Philadelphia chromosome positive (Ph+) B-precursor acute lymphoblastic leukemia (ALL) who receive blinatumomab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Germany, Italy, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 4, 2013
Enrollment StartJan 3, 2014
Primary CompletionMay 20, 2015
Study CompletionJan 6, 2017
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.6 years ago

Interventions

Blinatumomabdrug

Blinatumomab is administered as a continuous intravenous infusion (CIV). A single cycle of blinatumomab treatment is 6 weeks in duration, which includes 4 weeks of blinatumomab followed by a 2-week treatment-free interval.