A Phase I Study of L-asparaginase Encapsulated in Red Blood Cells (Eryaspase) in Combination With the CALGB Regimen During Induction and Consolidation Phases in the Treatment of Adult Patients With Acute Lymphoblastic Leukemia and Lymphoma
Phase of Trial: Phase I/II
Latest Information Update: 28 Sep 2017
At a glance
- Drugs ERY-ASP (Primary) ; Antineoplastics
- Indications Acute lymphoblastic leukaemia
- Focus Adverse reactions
- Sponsors ERYtech Pharma
- 28 Sep 2017 According to an ERYtech Pharma media release, all patients had been treated in the third dose escalation cohort of phase I part of the study. The steering committee of the study reviewed the safety data of all three treatment cohorts and agreed to pursue further development at the dose level of 100 U/kg.
- 10 Apr 2017 Planned primary completion date changed from 1 Mar 2017 to 1 Dec 2017.
- 13 Feb 2017 Planned number of patients changed from 12 to 24.