Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01687387
Recruitment Status : Completed
First Posted : September 18, 2012
Results First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Innate Pharma

Tracking Information
First Submitted Date  ICMJE September 11, 2012
First Posted Date  ICMJE September 18, 2012
Results First Submitted Date  ICMJE December 15, 2017
Results First Posted Date  ICMJE February 8, 2019
Last Update Posted Date February 8, 2019
Study Start Date  ICMJE October 2012
Actual Primary Completion Date November 17, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2012)
Leukemia-Free Survival [ Time Frame: from date of randomization until the date of first documented relapse, assessed up to 48 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
Number of Participants With Adverse Events [ Time Frame: 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 ]
Number of Participants with Adverse Events based on full physical examination each treatment visit and collection of AEs
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2012)
Number of adverse events [ Time Frame: 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 ]
based on full physical examination each treatment visit and collection of AEs
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of Anti-KIR Monoclonal Antibody as Maintenance Treatment in Acute Myeloid Leukemia (EFFIKIR)
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Myeloid Leukemia
Intervention  ICMJE
  • Drug: IPH2102 at 0.1 mg/kg
    every 3 months
    Other Name: lirilumab/BMS986015
  • Drug: IPH2102 at 1 mg/kg
    every 4 weeks
    Other Name: lirilumab/BMS986015
  • Drug: Placebo (normal saline solution)
    every 4 weeks
    Other Name: normal saline solution
Study Arms  ICMJE
  • Experimental: IPH2102 at 1 mg/kg
    lirilumab (IPH2102/BMS986015) at 1 mg/kg
    Intervention: Drug: IPH2102 at 1 mg/kg
  • Experimental: IPH2102 at 0.1 mg/kg
    lirilumab (IPH2102/BMS986015) at 0.1 mg/kg
    Interventions:
    • Drug: IPH2102 at 0.1 mg/kg
    • Drug: Placebo (normal saline solution)
  • Placebo Comparator: Placebo (Normal saline solution)
    Normal saline solution
    Intervention: Drug: Placebo (normal saline solution)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 6, 2018)
152
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2012)
150
Actual Study Completion Date  ICMJE November 17, 2016
Actual Primary Completion Date November 17, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01687387
Other Study ID Numbers  ICMJE IPH2102-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Innate Pharma
Study Sponsor  ICMJE Innate Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Norbert Vey, MD Institut Paoli Calmettes Marseille France
Study Chair: Hervé Dombret, MD ALFA cooperative Group
Study Chair: Norbert Ifrah, MD GOELAMS Cooperative Group
PRS Account Innate Pharma
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP