Efficacy Study of Anti-KIR Monoclonal Antibody as Maintenance Treatment in Acute Myeloid Leukemia (EFFIKIR)

Acute Myeloid Leukemia Clinical Trial

— EFFIKIR  

Official title:

Double-Blind Placebo-Controlled Randomized Phase 2 Study of IPH2102 as Maintenance Treatment in Elderly Patients With Acute Myeloid Leukemia (AML) in First Complete Remission

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01687387
• Other study ID #: IPH2102-201
• Status: Completed
• Phase: Phase 2
• Start date: October 2012
• Est. completion date: November 17, 2016

Study information

• Verified date: September 2018
• Source: Innate Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Double-Blind Placebo-Controlled Randomized Phase 2 Study evaluating the efficacy of lirilumab (IPH2102/BMS-986015) as Maintenance Treatment administered in elderly patients with Acute Myeloid Leukemia (AML) in first complete remission

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: November 17, 2016
• Est. primary completion date: November 17, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Primary or secondary Acute Myeloid Leukemia (AML, defined according to WHO 2008 criteria), in first CR/CRi (according to the revised recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia J Clin Oncol. 2003 Dec 15; 21(24):4642-9 see appendix 19.3) following induction chemotherapy and who received 1 or 2 consolidation cycles. Induction chemotherapy should be performed within 6 months before randomization. Consolidation cycle is defined as any chemotherapy administered within 3 months following CR and including aracytine irrespective of the administered dose(s). A minimum of one and maximum of 2 cycles should be administered before enrollment

2. Patients not eligible for an allogeneic hematopoietic cell transplantation

3. Age 60 to 80

4. ECOG Performance status of 0 or 1

5. Clinical laboratory values at screening

• Calculated creatinine clearance (according to MDRD) > 60 ml/min/1.73 m2

• Platelet > 75 x 109/l

• Hemoglobin = 10 g/dl supported or unsupported by transfusions

• ANC > 1 x 109/l

• Total Bilirubin levels = 1.5 ULN

• ALT and AST = 3 ULN

6. Recovery from acute toxicity of previous anti-tumor therapy

7. Male patients who accept and are able to use contraception methods recognized as highly effective.

8. Signed informed consent prior to any protocol specific procedure.

Exclusion Criteria:

1. Acute Promyelocytic Leukemia with t (15; 17), or its molecular equivalents (PML-RARA)

2. Favorable risk AML corresponding defined as t(8;21) or inv (16) and t(16;16) and their molecular equivalents (AML-ETO and CBFB-MYH11)

3. Last consolidation completed more than 3 months prior to first dosing

4. Concomitant treatment by chemotherapy, immunotherapy or by systemic corticosteroids

5. Within 28 days prior to first dosing: chemotherapy or systemic corticosteroid treatment

6. History of allogeneic hematopoietic cell transplantation or solid organ transplantation

7. History of high dose chemotherapy with autologous hematopoietic transplantation performed as treatment for AML

8. Use of any investigational agent within 2 months prior to the first dosing

9. Use of growth factors (G- or GM-CSF or EPO) within 28 days prior to first dosing

10. Any irradiation within the last 3 months except for analgesic intent

11. Intermittent or continuous renal replacement therapy

12. Abnormal cardiac status with any of the following

• Ejection fraction (measured by ultra-sound or radionuclide imaging) <50%

• Myocardial infarction within the previous 6 months

• QTc = 480 ms (Bazett's).

13. Current active infectious disease or positive serology for HIV, and/or HCV with detectable viremia and/ or HBV with positive Hbs Antigen and/or negative anti Hbs Antibody

14. Auto-immune disease:

• Which currently or previously required systemic immunosuppressive or immuno-modulatory therapy (including corticosteroids administered by systemic route)

• And/or has substantial probability to cause an irreversible injury to any tissue

• And/or is recent or unstable or has substantial risk to progress and cause severe complications.

15. Serious concurrent uncontrolled medical disorder

16. History of another malignancy (apart from myelodysplastic syndromes, basal cell carcinoma of the skin, or in situ cervix carcinoma) except if free of disease for = 3 years

17. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• IPH2102 at 0.1 mg/kg
every 3 months
• IPH2102 at 1 mg/kg
every 4 weeks
• Placebo (normal saline solution)
every 4 weeks

Locations

Country	Name	City	State
France	CHU d'Amiens	Amiens
France	CHU Angers	Angers
France	Centre hospitalier Victor Dupouy	Argenteuil
France	Centre hospitalier de la côte Basque	Bayonne
France	CHU de Besançon	Besançon
France	CHG de Béziers	Béziers
France	CH de Blois	Blois
France	Hôpital Avicenne	Bobigny
France	Hôpital Morvan CHU Brest	Brest
France	CH René Dubos	Cergy Pontoise
France	Hôpital Militaire Percy	Clamart
France	CHU Estaing	Clermont-Ferrand
France	Centre hospitalier sud francilien	Corbeil Essonnes
France	Hôpital Henri Mondor	Créteil
France	CHU de Grenoble	Grenoble
France	Centre Hospitalier de Versailles	Le Chesnay Cedex
France	Hôpital Claude Huriez	Lille
France	CHU de Limoges	Limoges
France	Institut Paoli - Calmettes	Marseille Cedex 09
France	CH de Meaux	Meaux
France	CHU Saint Eloi	Montpellier Cedex 5
France	Centre Hospitalier de Mulhouse	Mulhouse
France	CHU de Nantes	Nantes
France	Centre Antoine Lacassagne	Nice
France	CHU Caremeau	Nîmes
France	CHR d'Orléans	Orléans
France	Hôpital Saint-Antoine	Paris
France	Hôpital Saint-Louis	Paris
France	Hôpital Necker	Paris Cedex 15
France	CH Saint-Jean	Perpignan
France	CHU de Bordeaux - Hôpital Haut-Lévêque	Pessac
France	Centre hospitalier Lyon Sud	Pierre Bénite
France	CHU de Poitiers	Poitiers
France	CHR d'Annecy	Pringy
France	CHU de Reims	Reims
France	Centre Henri Becquerel	Rouen
France	Centre René Huguenin	Saint-Cloud
France	CH Saint-Quentin	Saint-Quentin
France	Hôpital Haute Pierre et Hôpital Civil	Strasbourg
France	CHU Purpan	Toulouse
France	CH Valenciennes	Valenciennes
France	CHU de Nancy Hôpitaux de Brabois	Vandoeuvre Les Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Innate Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leukemia-Free Survival		from date of randomization until the date of first documented relapse, assessed up to 48 months
Secondary	Number of Participants With Adverse Events	Number of Participants with Adverse Events based on full physical examination each treatment visit and collection of AEs	from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit, up to 24 months