Trial Profile
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
Status:
Discontinued
Phase of Trial:
Phase I/II
Latest Information Update: 12 Jul 2018
Price :
$35
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At a glance
- Drugs ERY-ASP (Primary) ; Antineoplastics
- Indications Precursor cell lymphoblastic leukaemia-lymphoma
- Focus Adverse reactions
- Sponsors ERYtech Pharma
- 24 Jun 2018 According to a ERYtech Pharma media release, the company has ceased the development of Eryaspase in Acute Lymphoblastic Leukemia (ALL)including the withdrawal of its European MAA, based on recent feedback from the regulatory agencies in Europe and the United States, which states that, the company would require an additional investment in order to seek regulatory approval of eryaspase for the treatment of ALL.
- 24 Jun 2018 Status changed from recruiting to discontinued, according to a ERYtech Pharma media release.
- 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.