GRASPA Treatment for Patients With Acute Myeloblastic Leukemia

NCT01810705 | Completed Phase 2 Results DMC

• 1 other identifier: GRASPA-AML2012-01
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 21

Brief 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.

Conditions

Acute Myeloid Leukemia

Keywords

myeloid; leukemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Response to Treatment

  Each patient will be followed for a duration of 24 months.

• Progression Free Survival (PFS)

  Each patient will be followed for a duration of 24 months.

• Patient Quality of Life

  Each patient will be followed for a duration of 24 months.

• Safety of GRASPA Adverse Events and Serious Adverse Events

  Each patient will be followed for a duration of 24 months.

• Relapse Free Survival

  Each patient will be followed for a duration of 24 months.

Study Arms (2)

GRASPA

EXPERIMENTAL

patients will receive one injection of GRASPA (100 IU/kg) after each course of low-dose cytarabine (see Arm "Control")

Drug: GRASPA

Control

NO INTERVENTION

patients will receive successive courses of low intensive chemotherapy, as subcutaneous low-dose cytarabine 20mg twice daily for 10 days per course (from day 1 to day 10), each course occurring every 28 days, for a duration up to 24 months

Interventions

GRASPA DRUG

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

Also known as: L-asparaginase encapsulated in red blood cells

GRASPA

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ERYtech Pharma: lead

Study Sites (21)

Hôpital l'Archet 1

Nice, Alpes Maritimes, 06200, France

Location

Centre Léon Bérard

Lyon, Auvergne-Rhône-Alpes, 69008, France

Location

Centre hospitalier Lyon Sud

Pierre-Bénite, Auvergne-Rhône-Alpes, 69310, France

Location

Institut Paoli Calmettes

Marseille, Bouche Du Rhone, 13000, France

Location

Hôpital JEAN MINJOZ

Besançon, Doubs, 25000, France

Location

Hopital Morvan

Brest, Finistere, 29200, France

Location

Hôpital Haut-Lévèque

Pessac, Gironde, 33600, France

Location

CHRU de Nîmes

Nîmes, Guard, 30000, France

Location

Hopital de Hautepierre

Strasbourg, Haut Rhin, 67000, France

Location

Hopital De Purpan CHU Toulouse

Toulouse, Haute Garonne, 31500, France

Location

Hopital Région d'Annecy

Pringy, Haute Savoie, 74000, France

Location

Hôpital Saint Eloi

Montpellier, Hérault, 34295, France

Location

Hôtel Dieu - CHU de NANTES

Nantes, Loire Atlantique, 44200, France

Location

Chu D'Angers

Angers, Maine Et Loire, 49000, France

Location

Hopital de Brabois

Vandœuvre-lès-Nancy, Meurthe Et Moselle, 54500, France

Location

Hôpital Claude-Huriez

Lille, Nord, 59800, France

Location

Institut de Cancérologie de la Loire

Saint-priest-en-jarez, Pays de la Loire Region, 42270, France

Location

CHU Estaing

Clermont-Ferrand, Puy De Dome, 63000, France

Location

hopital de Perpignan

Perpignan, Pyrénées Orientales, 66100, France

Location

Centre Henri Becquerel

Rouen, Seine Maritime, 76100, France

Location

Groupe Hospitalier Sud

Amiens, Somme, 80090, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia

Interventions

eryaspase

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Anne-Sophie Clermont
• Organization: Erytech Pharma

anne-sophie.clermont@erytech.com

+33 4 78 78 15 70

Study Officials

• X Thomas, Doctor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2013
• First Posted: March 13, 2013
• Study Start: February 1, 2013
• Primary Completion: November 10, 2017
• Study Completion: November 10, 2017
• Last Updated: February 21, 2022
• Results First Posted: February 21, 2022

Record last verified: 2022-02

Locations

FR (21)