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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

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

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: IPH2102 at 0.1 mg/kg Drug: IPH2102 at 1 mg/kg Drug: Placebo (normal saline solution) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2012
Actual Primary Completion Date : November 17, 2016
Actual Study Completion Date : November 17, 2016


Arm Intervention/treatment
Experimental: IPH2102 at 1 mg/kg
lirilumab (IPH2102/BMS986015) at 1 mg/kg
Drug: IPH2102 at 1 mg/kg
every 4 weeks
Other Name: lirilumab/BMS986015

Experimental: IPH2102 at 0.1 mg/kg
lirilumab (IPH2102/BMS986015) at 0.1 mg/kg
Drug: IPH2102 at 0.1 mg/kg
every 3 months
Other Name: lirilumab/BMS986015

Drug: Placebo (normal saline solution)
every 4 weeks
Other Name: normal saline solution

Placebo Comparator: Placebo (Normal saline solution)
Normal saline solution
Drug: Placebo (normal saline solution)
every 4 weeks
Other Name: normal saline solution




Primary Outcome Measures :
  1. Leukemia-Free Survival [ Time Frame: from date of randomization until the date of first documented relapse, assessed up to 48 months ]

Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687387


Locations
Show Show 43 study locations
Sponsors and Collaborators
Innate Pharma
Investigators
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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

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Responsible Party: Innate Pharma
ClinicalTrials.gov Identifier: NCT01687387    
Other Study ID Numbers: IPH2102-201
First Posted: September 18, 2012    Key Record Dates
Results First Posted: February 8, 2019
Last Update Posted: February 8, 2019
Last Verified: September 2018
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Pharmaceutical Solutions