Phase 2
N=123
GRASPA Treatment for Patients With Acute Myeloblastic Leukemia
Acute Myeloid Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT01810705 ↗Enrolled (actual)
123
Serious AEs
88.3%
Results posted
Feb 2022
Primary outcome: Primary: Overall Survival — 4.8; 6.4 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GRASPA (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- ERYtech Pharma
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
4.8; 6.4 | — |
| SECONDARY Response to Treatment |
— | — |
| SECONDARY Progression Free Survival (PFS) |
— | — |
| SECONDARY Patient Quality of Life |
— | — |
| SECONDARY Safety of GRASPA Adverse Events and Serious Adverse Events |
— | — |
| SECONDARY Relapse Free Survival |
— | — |
| SECONDARY Number of Hospitalizations |
— | — |
| SECONDARY Percentage of Patients Who Need Transfusions |
— | — |
| SECONDARY Pharmacodynamic and Pharmacokinetic Parameters of GRASPA |
— | — |
| SECONDARY Immunogenicity |
— | — |
| SECONDARY Asparagine Synthetase (Optional) |
— | — |
| SECONDARY Biomarker Cytogenetic Testing (Optional) |
— | — |
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.
Eligibility Criteria
Inclusion criteria
- Patient > 65 years old and 2 x ULN (Upper Limit of Normal), AST or ALT levels > 3.5xULN or 5xULN if related to AML, Total bilirubin > 2 x ULN, INR > 1.5, unless patient under chronic treatment with anticoagulants (in this case, INR should be within expected ranges for the specific condition), Insulin-dependent or uncontrolled diabetes mellitus
- Concurrent malignancies other than AML requiring chemotherapy
- Severe active infection, HIV seropositivity, or known active type B or C viral hepatitis
- Known or suspected hypersensitivity or intolerance to mannitol
- Breastfeeding or lactating women
Data sourced from ClinicalTrials.gov (NCT01810705). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.