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

NCT01687387 | Completed Phase 2 Results DMC

• 1 other identifier: IPH2102-201
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 43

Brief 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

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Leukemia-Free Survival

  from date of randomization until the date of first documented relapse, assessed up to 48 months

Secondary Outcomes (1)

• Number of Participants With Adverse Events

  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

Study Arms (3)

IPH2102 at 1 mg/kg

EXPERIMENTAL

lirilumab (IPH2102/BMS986015) at 1 mg/kg

Drug: IPH2102 at 1 mg/kg

IPH2102 at 0.1 mg/kg

EXPERIMENTAL

lirilumab (IPH2102/BMS986015) at 0.1 mg/kg

Drug: IPH2102 at 0.1 mg/kg; Drug: Placebo (normal saline solution)

Placebo (Normal saline solution)

PLACEBO COMPARATOR

Normal saline solution

Drug: Placebo (normal saline solution)

Interventions

IPH2102 at 0.1 mg/kg DRUG

every 3 months

Also known as: lirilumab/BMS986015

IPH2102 at 0.1 mg/kg

IPH2102 at 1 mg/kg DRUG

every 4 weeks

Also known as: lirilumab/BMS986015

IPH2102 at 1 mg/kg

Placebo (normal saline solution) DRUG

every 4 weeks

Also known as: normal saline solution

IPH2102 at 0.1 mg/kg; Placebo (Normal saline solution)

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patients not eligible for an allogeneic hematopoietic cell transplantation
• Age 60 to 80
• ECOG Performance status of 0 or 1
• 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
• Recovery from acute toxicity of previous anti-tumor therapy
• Male patients who accept and are able to use contraception methods recognized as highly effective.
• Signed informed consent prior to any protocol specific procedure.

You may not qualify if:

• Acute Promyelocytic Leukemia with t (15; 17), or its molecular equivalents (PML-RARA)
• 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)
• Last consolidation completed more than 3 months prior to first dosing
• Concomitant treatment by chemotherapy, immunotherapy or by systemic corticosteroids
• Within 28 days prior to first dosing: chemotherapy or systemic corticosteroid treatment
• History of allogeneic hematopoietic cell transplantation or solid organ transplantation
• History of high dose chemotherapy with autologous hematopoietic transplantation performed as treatment for AML
• Use of any investigational agent within 2 months prior to the first dosing
• Use of growth factors (G- or GM-CSF or EPO) within 28 days prior to first dosing
• Any irradiation within the last 3 months except for analgesic intent
• Intermittent or continuous renal replacement therapy
• 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).

Sponsors & Collaborators

• Innate Pharma: lead

Study Sites (43)

CHU d'Amiens

Amiens, 80054, France

Location

CHU Angers

Angers, 49933, France

Location

Centre hospitalier Victor Dupouy

Argenteuil, 95107, France

Location

Centre hospitalier de la côte Basque

Bayonne, 64100, France

Location

CHU de Besançon

Besançon, 25030, France

Location

CHG de Béziers

Béziers, 34500, France

Location

CH de Blois

Blois, 41000, France

Location

Hôpital Avicenne

Bobigny, 93000, France

Location

Hôpital Morvan CHU Brest

Brest, 29609, France

Location

CH René Dubos

Cergy-Pontoise, 95303, France

Location

Hôpital Militaire Percy

Clamart, 92141, France

Location

CHU Estaing

Clermont-Ferrand, 63003, France

Location

Centre hospitalier sud francilien

Corbeil-Essonnes, 91100, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

CHU de Grenoble

Grenoble, 38043, France

Location

Centre Hospitalier de Versailles

Le Chesnay, 78157, France

Location

Hôpital Claude Huriez

Lille, 59037, France

Location

CHU de Limoges

Limoges, 87042, France

Location

Institut Paoli - Calmettes

Marseille, 13273, France

Location

CH de Meaux

Meaux, 77104, France

Location

CHU Saint Eloi

Montpellier, 34295, France

Location

Centre Hospitalier de Mulhouse

Mulhouse, 68100, France

Location

CHU de Nantes

Nantes, 44000, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

CHU Caremeau

Nîmes, 30029, France

Location

CHR d'Orléans

Orléans, 45067, France

Location

Hôpital Saint-Louis

Paris, 75010, France

Location

Hôpital Saint-Antoine

Paris, 75012, France

Location

Hôpital Necker

Paris, 75743, France

Location

CH Saint-Jean

Perpignan, 66000, France

Location

CHU de Bordeaux - Hôpital Haut-Lévêque

Pessac, 33604, France

Location

Centre hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

CHR d'Annecy

Pringy, 74374, France

Location

CHU de Reims

Reims, 51092, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Centre René Huguenin

Saint-Cloud, 92210, France

Location

CH Saint-Quentin

Saint-Quentin, 02321, France

Location

Hôpital Haute Pierre et Hôpital Civil

Strasbourg, 67098, France

Location

CHU Purpan

Toulouse, 31059, France

Location

CH Valenciennes

Valenciennes, 59322, France

Location

CHU de Nancy Hôpitaux de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

lirilumab; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Director Clinical Operations
• Organization: Innate Pharma

info@innate-pharma.fr

+33043030

Study Officials

• Norbert Vey, MD

  Institut Paoli Calmettes Marseille France

  PRINCIPAL INVESTIGATOR

• Hervé Dombret, MD

  ALFA cooperative Group

  STUDY CHAIR

• Norbert Ifrah, MD

  GOELAMS Cooperative Group

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 18, 2012
• Study Start: October 1, 2012
• Primary Completion: November 17, 2016
• Study Completion: November 17, 2016
• Last Updated: February 8, 2019
• Results First Posted: February 8, 2019

Record last verified: 2018-09

Locations

FR (43)