Acute Myeloid Leukemia Clinical Trial
— ENFORCEOfficial title:
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
Verified date | February 2022 |
Source | ERYtech Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 123 |
Est. completion date | November 10, 2017 |
Est. primary completion date | November 10, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years to 85 Years |
Eligibility | Inclusion criteria: - Patient > 65 years old and < 85 years old - Newly diagnosed Acute Myeloid Leukemia (AML) or post myelodysplastic syndrome diagnosed within 6 months prior to study enrollment - Unfit for intensive chemotherapy (at risk to suffer treatment related pejorative toxicities /early death) due to the presence of one or more of the following criteria: Dependence in activities of daily living owing to the presence of comorbidities other than those resulting from the deterioration caused by the neoplastic disease. Presence in the patient's medical history of three or more of the following comorbidities, even if they are under control with proper treatment: Congestive heart failure, other chronic cardiovascular diseases, chronic obstructive pulmonary disease, cerebrovascular disease, peripheral neuropathy, chronic kidney failure, hypertension, diabetes mellitus, systemic vasculitis, severe arthritis - Presence of geriatric syndromes such as fecal or urinary incontinence, spontaneous bone fractures, mild and moderate dementia, or patients who fall repeatedly, or, patient unwilling to receive intensive chemotherapy - Eligible to receive low-dose cytarabine treatment - ECOG performance status = 2 - Female patients of childbearing potential and males must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment and for 6 months after the last dose of Cytarabine or 3 months after last dose of GRASPA (whichever is the longest). - Negative serum pregnancy test at study entry for female subjects of childbearing potential - Subscription to social security insurance (if applicable, in accordance with local regulations) - Ability to understand, and willingness to sign, a written informed consent document and to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures 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) - Patient with secondary AML subsequent to prior malignant blood disorder such as: Myelodysplastic syndrome diagnosed more than 6 months before study entry or Myeloproliferative syndrome - Prior therapy to AML (standard therapy or investigational agents) - Inadequate organ function : 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, Serum creatinine concentration > 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 |
Country | Name | City | State |
---|---|---|---|
France | Groupe Hospitalier Sud | Amiens | Somme |
France | Chu D'Angers | Angers | Maine Et Loire |
France | Hôpital JEAN MINJOZ | Besancon | Doubs |
France | Hopital Morvan | Brest | Finistere |
France | CHU Estaing | Clermont-ferrand | Puy De Dome |
France | Hôpital Claude-Huriez | Lille | Nord |
France | Centre Léon Bérard | Lyon | Rhone Alpes |
France | Institut Paoli Calmettes | Marseille | Bouche Du Rhone |
France | Hôpital Saint Eloi | Montpellier | Hérault |
France | Hôtel Dieu - CHU de NANTES | Nantes | Loire Atlantique |
France | Hôpital l'Archet 1 | Nice | Alpes Maritimes |
France | CHRU de Nîmes | Nimes | Guard |
France | hopital de Perpignan | Perpignan | Pyrénées Orientales |
France | Hôpital Haut-Lévèque | Pessac | Gironde |
France | Centre hospitalier Lyon Sud | Pierre Benite | Rhone Alpes |
France | Hopital Région d'Annecy | Pringy | Haute Savoie |
France | Centre Henri Becquerel | Rouen | Seine Maritime |
France | Institut de Cancérologie de la Loire | Saint-priest-en-jarez | Loire |
France | Hopital de Hautepierre | Strasbourg | Haut Rhin |
France | Hopital De Purpan CHU Toulouse | Toulouse | Haute Garonne |
France | Hopital de Brabois | Vandoeuvre Les Nancy | Meurthe Et Moselle |
Lead Sponsor | Collaborator |
---|---|
ERYtech Pharma |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival | OS is defined as the time elapsed between randomization and death from any cause. | Each patient will be followed for a duration of 24 months. | |
Secondary | Response to Treatment | Percentage of patients with Complete remission (CR), Complete remission with incomplete recovery (neutrophil or platelet regeneration, CRi), Partial remission (PR) | Each patient will be followed for a duration of 24 months. | |
Secondary | Progression Free Survival (PFS) | Defined as the time elapsed between randomization and resistant disease or relapse or death from any cause | Each patient will be followed for a duration of 24 months. | |
Secondary | Patient Quality of Life | Collecting survey about patients quality of life | Each patient will be followed for a duration of 24 months. | |
Secondary | Safety of GRASPA Adverse Events and Serious Adverse Events | Number of incidences, type, severity and causality of adverse events / serious adverse events | Each patient will be followed for a duration of 24 months. | |
Secondary | Relapse Free Survival | Defined only for patients who achieve CR or CRi as the time elapsed between date of CR/CRi and date of disease relapse or death from any cause | Each patient will be followed for a duration of 24 months. | |
Secondary | Number of Hospitalizations | Hospitalizations (except schedule protocol visit during the study) | Each patient will be followed for a duration of 24 months. | |
Secondary | Percentage of Patients Who Need Transfusions | Number of transfusions per patient (red blood cells and or platelets) | Until patient stops treatment (expected average of 8 months) | |
Secondary | Pharmacodynamic and Pharmacokinetic Parameters of GRASPA | Plasma concentrations of asparagine, aspartate, glutamine, glutamate, whole blood L- asparaginase activity | Until patient stops treatment (expected average of 8 months) | |
Secondary | Immunogenicity | Titer of anti L-asparaginase antibodies | Until patient stops treatment (expected average of 8 months) | |
Secondary | Asparagine Synthetase (Optional) | Asparagine synthetase and in vitro sensitivity to aspariginase on the harvested bone marrow cells | Until patient stops treatment (expected average of 8 months) | |
Secondary | Biomarker Cytogenetic Testing (Optional) | Defined as cytogenetic biomarker testing | Until patient stops treatment (expected average of 8 months) |
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