Clinical trial with GRASPA, Red Blood cells encapsulating L-Asparaginase, in patients affected by Acute Myeloid leukemia
- Conditions
- Acute Myeloid LeukaemiaMedDRA version: 16.1Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-002026-78-ES
- Lead Sponsor
- ERYTECH Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 123
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate Progression Free Survival (PFS) in AML patients older than 65 unfit for intensive chemotherapy, when treated with GRASPA (L-asparaginase encapsulated in erythrocytes) plus low-dose cytarabine compared to low-dose cytarabine alone.;Secondary Objective: To evaluate<br>- Response to treatment<br>- Event Free Survival<br>- Overall survival<br>- Patient transfusion needs<br>- Patients Quality of life evolution<br>- Number of hospitalization<br>- Global safety of GRASPA in combination with cytarabine<br>- Pharmacokinetic and pharmacodynamic parameters of GRASPA<br>- Immunogenicity of GRASPA<br><br>Exploratory: Asparagine Synthetase exploration (in bone marrow cells);Primary end point(s): Progression free survival (PFS) defined as the time elapsed between treatment initiation and disease progression or death related to disease (AML or study treatment);Timepoint(s) of evaluation of this end point: Timepoint(s) of evaluation of Primary end points are described in E.5.1
- Secondary Outcome Measures
Name Time Method