CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
Ara-C +1 moredrug
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/NCT01838395
NCT01838395Phase 2Completed

A Phase IIa, Multicenter, Open-Label Study Designed to Evaluate the Safety and Efficacy of Escalating Doses of BL-8040 in Adult Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML)

BioLineRx, Ltd.·interventional·Posted Apr 24, 2013·Updated Sep 19, 2024

In Brief

A Phase 2 clinical trial evaluating Ara-C and BL-8040 for Acute Myeloid Leukemia. Completed, enrolled 42 participants across 10 sites in 2 countries.

Detailed Summary

A study is designed to assess if BL-8040 in combination with cytarabine (Ara-C) can help controlling the disease in patients with Acute Myeloid Leukemia (AML) that have relapsed or did not respond adequately to previous treatment. The safety of the study drug combination will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIsrael, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 24, 2013
Enrollment StartApr 1, 2013
Primary CompletionMar 1, 2016
Study CompletionJul 20, 2023
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 13.2 years ago

Interventions

Ara-Cdrug

IV (intravenous administration)

BL-8040drug

SC (subcutaneous injection)