EUCTR2012-002026-78-FIActive, not recruitingPhase 1
A Multicentre, open, randomized, controlled phase IIb trial evaluating efficacy and tolerability of GRASPA (L-asparaginase encapsulated in red blood cells) plus low-dose cytarabine vs low-dose cytarabine alone, in treatment of newly diagnosed acute myeloid leukemia (AML) patients, over 65 years, unfit for intensive chemotherapy. - GRASPA-M
ERYTECH Pharma0 sites123 target enrollmentStarted: November 5, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 123
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Patient over 65 years old and less than 85 years old
- •- Newly diagnosed Acute Myeloid Leukemia (AML) or post myelodysplastic syndrome diagnosed in the 6 months prior to study enrollment
- •- Unfit for intensive chemotherapy (at risk to suffer treatment related pejorative toxicities /early death) or patient unwilling to receive intensive chemotherapy
- •- WHO performance status =2 and estimated life expectancy = 3 months
- •- Eligible to receive low-dose cytarabine treatment
- •- Evidence of post-menopausal status for female (absence of menstruation for 12 months)
- •- Subscription to social security insurance
- •- Provision of written Informed Consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 123
Exclusion Criteria
- •- Patients with M3 AML of FAB classification (APL, acute promyelocytic leukemia)
- •- Patients with AML involving chromosome 16 abnormalities or translocation (8:21) (CBF-AML)
- •- History of grade 3-4 pancreatitis or grade 3-4 thromboembolic event (according NCI-CTCAE Version 4.0)
- •- Presenting with a general or visceral contraindication including :
- •* Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis. Cardiac insufficiency defined as Left Ventricular Ejection Fraction < 50% of the theoretical value
- •* Plasma creatinine concentration, 2 times greater than the upper limit of laboratory ranges, except if related to AML
- •* AST or ALT levels, 3.5 times greater than the upper limit of laboratory ranges, except if related to AML
- •* Patient presenting evolutive cancer other than AML, except in situ basal-cell carcinoma or in situ cervix cancer
- •* Severe evolutive infection, or, HIV seropositive or, active hepatitis related to B or C viral infection
- •- History of Grade 3 Transfusional incident (life threatening)
- •- Has known or suspected hypersensitivity or intolerance to mannitol, or heparin
- •- Patient presenting contra indication to cytarabine treatment (hypersensitivity to cytarabine, antimitotic treatment, preexisting medullary aplasia, toxic degenerative encephalopathy - especially after methotrexate treatment or ioniding radiations-, yellow fever vaccination)
- •- Participation in an investigational drug study within the 30 days prior to entry
Investigators
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