At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 123 enrolled
Drug / intervention
GRASPAdrug
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.
A Multicenter, Open, Randomized, Controlled Phase IIb Trial Evaluating Efficacy and Tolerability of GRASPA (L-asparaginase Encapsulated in Red Blood Cells, Eryaspase) Plus Low-dose Cytarabine vs Low-dose Cytarabine Alone, in Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) Elderly Patients, Unfit for Intensive Chemotherapy
In Brief
A Phase 2 clinical trial evaluating GRASPA for Acute Myeloid Leukemia. Completed, enrolled 123 participants across 21 sites.
Detailed Summary
The protocol aims at adding GRASPA (L-asparaginase encapsulated in red blood cells, eryaspase) to standard chemotherapy (low-dose cytarabine) to treat patients older than 65 years diagnosed with AML and unfit for intensive chemotherapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia
CountriesFrance
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2013
First PostedMar 2013
Primary CompletionNov 2017
TodayJul 2026
First PostedMar 13, 2013
Enrollment StartFeb 1, 2013
Primary CompletionNov 10, 2017
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 13.3 years ago
Interventions
GRASPAdrug
Patients receiving Intervention (experimental group) will be treated with one injection of graspa per cycle of treatment, each cycle during 28 days, for a duration up to 24 cycles maximum