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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acute Myeloid Leukemia
Interventions Drug: IPH2102 at 0.1 mg/kg
Drug: IPH2102 at 1 mg/kg
Drug: Placebo (normal saline solution)
Enrollment 152
Recruitment Details 169 patients were screened and 152 patients were randomized and treated in France
Pre-assignment Details  
Arm/Group Title IPH2102 at 1 mg/kg IPH2102 at 0.1 mg/kg Placebo (Normal Saline Solution)
Hide Arm/Group Description

lirilumab (IPH2102/BMS986015) at 1 mg/kg

IPH2102 at 1 mg/kg: every 4 weeks

lirilumab (IPH2102/BMS986015) at 0.1 mg/kg

IPH2102 at 0.1 mg/kg: every 3 months

Placebo (normal saline solution): every 4 weeks

Normal saline solution

Placebo (normal saline solution): every 4 weeks

Period Title: Overall Study
Started 51 50 51
Completed 10 12 13
Not Completed 41 38 38
Arm/Group Title IPH2102 at 1 mg/kg IPH2102 at 0.1 mg/kg Placebo (Normal Saline Solution) Total
Hide Arm/Group Description

lirilumab (IPH2102/BMS986015) at 1 mg/kg

IPH2102 at 1 mg/kg: every 4 weeks

lirilumab (IPH2102/BMS986015) at 0.1 mg/kg

IPH2102 at 0.1 mg/kg: every 3 months

Placebo (normal saline solution): every 4 weeks

Normal saline solution

Placebo (normal saline solution): every 4 weeks

Total of all reporting groups
Overall Number of Baseline Participants 51 50 51 152
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 51 participants 50 participants 51 participants 152 participants
70
(60 to 80)
70
(60 to 80)
68
(60 to 77)
70
(60 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 50 participants 51 participants 152 participants
Female
28
  54.9%
16
  32.0%
17
  33.3%
61
  40.1%
Male
23
  45.1%
34
  68.0%
34
  66.7%
91
  59.9%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
France Number Analyzed 51 participants 50 participants 51 participants 152 participants
51 50 51 152
1.Primary Outcome
Title Leukemia-Free Survival
Hide Description [Not Specified]
Time Frame from date of randomization until the date of first documented relapse, assessed up to 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IPH2102 at 1 mg/kg IPH2102 at 0.1 mg/kg Placebo (Normal Saline Solution)
Hide Arm/Group Description:

lirilumab (IPH2102/BMS986015) at 1 mg/kg

IPH2102 at 1 mg/kg: every 4 weeks

lirilumab (IPH2102/BMS986015) at 0.1 mg/kg

IPH2102 at 0.1 mg/kg: every 3 months

Placebo (normal saline solution): every 4 weeks

Normal saline solution

Placebo (normal saline solution): every 4 weeks

Overall Number of Participants Analyzed 51 50 51
Median (95% Confidence Interval)
Unit of Measure: MONTHS
6.7
(2.9 to 14.8)
17.6
(11.2 to 25)
13.9
(7.9 to 27.9)
2.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Number of Participants with Adverse Events based on full physical examination each treatment visit and collection of AEs
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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IPH2102 at 1 mg/kg IPH2102 at 0.1 mg/kg Placebo (Normal Saline Solution)
Hide Arm/Group Description:

lirilumab (IPH2102/BMS986015) at 1 mg/kg

IPH2102 at 1 mg/kg: every 4 weeks

lirilumab (IPH2102/BMS986015) at 0.1 mg/kg

IPH2102 at 0.1 mg/kg: every 3 months

Placebo (normal saline solution): every 4 weeks

Normal saline solution

Placebo (normal saline solution): every 4 weeks

Overall Number of Participants Analyzed 51 50 51
Measure Type: Count of Participants
Unit of Measure: Participants
43
  84.3%
49
  98.0%
47
  92.2%
Time Frame AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient’s last study visit
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IPH2102 at 1 mg/kg IPH2102 at 0.1 mg/kg Placebo (Normal Saline Solution)
Hide Arm/Group Description

lirilumab (IPH2102/BMS986015) at 1 mg/kg

IPH2102 at 1 mg/kg: every 4 weeks

lirilumab (IPH2102/BMS986015) at 0.1 mg/kg

IPH2102 at 0.1 mg/kg: every 3 months

Placebo (normal saline solution): every 4 weeks

Normal saline solution

Placebo (normal saline solution): every 4 weeks

All-Cause Mortality
IPH2102 at 1 mg/kg IPH2102 at 0.1 mg/kg Placebo (Normal Saline Solution)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   32/51 (62.75%)      26/50 (52.00%)      23/51 (45.10%)    
Hide Serious Adverse Events
IPH2102 at 1 mg/kg IPH2102 at 0.1 mg/kg Placebo (Normal Saline Solution)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/51 (23.53%)      17/50 (34.00%)      11/51 (21.57%)    
Blood and lymphatic system disorders       
Anaemia   1/51 (1.96%)  1 0/50 (0.00%)  0 0/51 (0.00%)  0
Neutropenia   0/51 (0.00%)  0 0/50 (0.00%)  0 2/51 (3.92%)  2
Cardiac disorders       
Atrial fibrillation   1/51 (1.96%)  1 0/50 (0.00%)  0 0/51 (0.00%)  0
Congenital, familial and genetic disorders       
Hydrocele   1/51 (1.96%)  1 0/50 (0.00%)  0 0/51 (0.00%)  0
Endocrine disorders       
Hyperthyroidism   1/51 (1.96%)  1 0/50 (0.00%)  0 0/51 (0.00%)  0
Eye disorders       
Chorioretinal disorder   0/51 (0.00%)  0 0/50 (0.00%)  0 1/51 (1.96%)  1
Gastrointestinal disorders       
Abdominal wall haematoma   0/51 (0.00%)  0 1/50 (2.00%)  1 0/51 (0.00%)  0
Diarrhoea   1/51 (1.96%)  1 0/50 (0.00%)  0 0/51 (0.00%)  0
Umbilical hernia   1/51 (1.96%)  1 1/50 (2.00%)  1 0/51 (0.00%)  0
General disorders       
Fatigue   0/51 (0.00%)  0 1/50 (2.00%)  1 0/51 (0.00%)  0
General physical health deterioration   0/51 (0.00%)  0 2/50 (4.00%)  2 0/51 (0.00%)  0
Pyrexia   0/51 (0.00%)  0 1/50 (2.00%)  1 0/51 (0.00%)  0
Hepatobiliary disorders       
Cholecystitis   1/51 (1.96%)  1 0/50 (0.00%)  0 1/51 (1.96%)  1
Infections and infestations       
Anal abscess   0/51 (0.00%)  0 1/50 (2.00%)  1 0/51 (0.00%)  0
Device related infection   1/51 (1.96%)  1 0/50 (0.00%)  0 0/51 (0.00%)  0
Peritonitis   0/51 (0.00%)  0 1/50 (2.00%)  1 0/51 (0.00%)  0
Pneumonia   0/51 (0.00%)  0 1/50 (2.00%)  1 0/51 (0.00%)  0
Sepsis   0/51 (0.00%)  0 1/50 (2.00%)  1 0/51 (0.00%)  0
Septic shock   0/51 (0.00%)  0 1/50 (2.00%)  1 0/51 (0.00%)  0
Sialoadenitis   0/51 (0.00%)  0 1/50 (2.00%)  1 0/51 (0.00%)  0
Staphylococcal sepsis   1/51 (1.96%)  1 0/50 (0.00%)  0 0/51 (0.00%)  0
Urinary tract infection   0/51 (0.00%)  0 1/50 (2.00%)  1 0/51 (0.00%)  0
Urosepsis   1/51 (1.96%)  1 0/50 (0.00%)  0 0/51 (0.00%)  0
Injury, poisoning and procedural complications       
Head injury   1/51 (1.96%)  1 0/50 (0.00%)  0 0/51 (0.00%)  0
Injury corneal   1/51 (1.96%)  1 0/50 (0.00%)  0 0/51 (0.00%)  0
Subdural haematoma   1/51 (1.96%)  1 0/50 (0.00%)  0 0/51 (0.00%)  0
Investigations       
Biopsy spleen   0/51 (0.00%)  0 1/50 (2.00%)  1 0/51 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia   1/51 (1.96%)  1 0/50 (0.00%)  0 0/51 (0.00%)  0
Chondrocalcinosis   0/51 (0.00%)  0 1/50 (2.00%)  1 0/51 (0.00%)  0
Myalgia   0/51 (0.00%)  0 1/50 (2.00%)  1 0/51 (0.00%)  0
Osteoarthritis   1/51 (1.96%)  1 0/50 (0.00%)  0 0/51 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Basal cell carcinoma   0/51 (0.00%)  0 3/50 (6.00%)  3 2/51 (3.92%)  2
Invasive lobular breast carcinoma   0/51 (0.00%)  0 0/50 (0.00%)  0 1/51 (1.96%)  1
Lung cancer metastatic   1/51 (1.96%)  1 0/50 (0.00%)  0 0/51 (0.00%)  0
Lymphoma   0/51 (0.00%)  0 1/50 (2.00%)  1 0/51 (0.00%)  0
Myelodysplastic syndrome   0/51 (0.00%)  0 0/50 (0.00%)  0 1/51 (1.96%)  1
Myxofibrosarcoma   0/51 (0.00%)  0 1/50 (2.00%)  1 0/51 (0.00%)  0
Papillary thyroid cancer   0/51 (0.00%)  0 1/50 (2.00%)  1 0/51 (0.00%)  0
Polycythaemia vera   0/51 (0.00%)  0 0/50 (0.00%)  0 1/51 (1.96%)  1
Rectal adenocarcinoma   0/51 (0.00%)  0 0/50 (0.00%)  0 1/51 (1.96%)  1
Nervous system disorders       
Encephalopathy   0/51 (0.00%)  0 1/50 (2.00%)  1 0/51 (0.00%)  0
Ischaemic stroke   0/51 (0.00%)  0 1/50 (2.00%)  1 0/51 (0.00%)  0
Sciatica   0/51 (0.00%)  0 1/50 (2.00%)  1 0/51 (0.00%)  0
Psychiatric disorders       
Suicide attempt   0/51 (0.00%)  0 0/50 (0.00%)  0 1/51 (1.96%)  1
Renal and urinary disorders       
Urinary incontinence   0/51 (0.00%)  0 1/50 (2.00%)  1 0/51 (0.00%)  0
Urinary retention   0/51 (0.00%)  0 1/50 (2.00%)  1 0/51 (0.00%)  0
Reproductive system and breast disorders       
Prostatitis   0/51 (0.00%)  0 1/50 (2.00%)  1 0/51 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism   1/51 (1.96%)  1 0/50 (0.00%)  0 0/51 (0.00%)  0
Pulmonary mass   0/51 (0.00%)  0 0/50 (0.00%)  0 1/51 (1.96%)  1
Skin and subcutaneous tissue disorders       
Acute febrile neutrophilic dermatosis   0/51 (0.00%)  0 0/50 (0.00%)  0 1/51 (1.96%)  1
Surgical and medical procedures       
Respiratory therapy   0/51 (0.00%)  0 1/50 (2.00%)  1 0/51 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IPH2102 at 1 mg/kg IPH2102 at 0.1 mg/kg Placebo (Normal Saline Solution)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/51 (74.51%)      48/50 (96.00%)      43/51 (84.31%)    
Blood and lymphatic system disorders       
Anaemia   3/51 (5.88%)  3 5/50 (10.00%)  5 2/51 (3.92%)  3
Neutropenia   4/51 (7.84%)  9 4/50 (8.00%)  5 5/51 (9.80%)  11
Thrombocytopenia   9/51 (17.65%)  9 7/50 (14.00%)  11 3/51 (5.88%)  4
Eye disorders       
Conjunctivitis   3/51 (5.88%)  3 0/50 (0.00%)  0 2/51 (3.92%)  2
Gastrointestinal disorders       
Abdominal pain   3/51 (5.88%)  3 3/50 (6.00%)  4 2/51 (3.92%)  4
Abdominal pain upper   0/51 (0.00%)  0 0/50 (0.00%)  0 3/51 (5.88%)  3
Constipation   2/51 (3.92%)  4 5/50 (10.00%)  5 3/51 (5.88%)  3
Diarrhoea   7/51 (13.73%)  8 6/50 (12.00%)  6 2/51 (3.92%)  2
Haemorrhoids   0/51 (0.00%)  0 1/50 (2.00%)  1 4/51 (7.84%)  4
Nausea   2/51 (3.92%)  3 6/50 (12.00%)  6 3/51 (5.88%)  3
General disorders       
Asthenia   14/51 (27.45%)  20 14/50 (28.00%)  19 14/51 (27.45%)  22
Chest pain   1/51 (1.96%)  1 4/50 (8.00%)  4 2/51 (3.92%)  2
Chills   4/51 (7.84%)  5 3/50 (6.00%)  4 1/51 (1.96%)  2
Fatigue   5/51 (9.80%)  5 2/50 (4.00%)  2 3/51 (5.88%)  4
Influenza like illness   2/51 (3.92%)  2 4/50 (8.00%)  5 5/51 (9.80%)  9
Oedema peripheral   1/51 (1.96%)  1 2/50 (4.00%)  2 3/51 (5.88%)  3
Pyrexia   6/51 (11.76%)  6 3/50 (6.00%)  3 5/51 (9.80%)  5
Infections and infestations       
Bronchitis   6/51 (11.76%)  9 17/50 (34.00%)  20 14/51 (27.45%)  15
Gastroenteritis   1/51 (1.96%)  1 4/50 (8.00%)  5 3/51 (5.88%)  4
Nasopharyngitis   2/51 (3.92%)  2 6/50 (12.00%)  6 6/51 (11.76%)  7
Oral herpes   0/51 (0.00%)  0 2/50 (4.00%)  2 3/51 (5.88%)  3
Pharyngitis   0/51 (0.00%)  0 3/50 (6.00%)  3 1/51 (1.96%)  1
Rhinitis   0/51 (0.00%)  0 3/50 (6.00%)  3 2/51 (3.92%)  2
Urinary tract infection   2/51 (3.92%)  4 2/50 (4.00%)  8 5/51 (9.80%)  7
Investigations       
Lipase increased   0/51 (0.00%)  0 3/50 (6.00%)  3 0/51 (0.00%)  0
Weight increased   1/51 (1.96%)  1 5/50 (10.00%)  6 6/51 (11.76%)  6
Musculoskeletal and connective tissue disorders       
Arthralgia   3/51 (5.88%)  3 6/50 (12.00%)  6 5/51 (9.80%)  5
Arthritis   0/51 (0.00%)  0 0/50 (0.00%)  0 3/51 (5.88%)  3
Back pain   3/51 (5.88%)  3 6/50 (12.00%)  7 7/51 (13.73%)  8
Muscle spasms   0/51 (0.00%)  0 2/50 (4.00%)  3 3/51 (5.88%)  3
Musculoskeletal pain   1/51 (1.96%)  1 4/50 (8.00%)  4 2/51 (3.92%)  2
Myalgia   0/51 (0.00%)  0 2/50 (4.00%)  2 4/51 (7.84%)  4
Neck pain   1/51 (1.96%)  1 0/50 (0.00%)  0 5/51 (9.80%)  6
Osteoarthritis   2/51 (3.92%)  2 1/50 (2.00%)  1 6/51 (11.76%)  6
Nervous system disorders       
Headache   8/51 (15.69%)  9 4/50 (8.00%)  9 3/51 (5.88%)  5
Neuropathy peripheral   2/51 (3.92%)  2 3/50 (6.00%)  4 1/51 (1.96%)  1
Paraesthesia   0/51 (0.00%)  0 6/50 (12.00%)  9 1/51 (1.96%)  1
Sciatica   1/51 (1.96%)  1 3/50 (6.00%)  3 0/51 (0.00%)  0
Psychiatric disorders       
Anxiety   4/51 (7.84%)  4 2/50 (4.00%)  2 3/51 (5.88%)  3
Respiratory, thoracic and mediastinal disorders       
Cough   2/51 (3.92%)  2 2/50 (4.00%)  2 3/51 (5.88%)  5
Dyspnoea   4/51 (7.84%)  4 1/50 (2.00%)  1 1/51 (1.96%)  1
Rhinorrhoea   0/51 (0.00%)  0 2/50 (4.00%)  2 3/51 (5.88%)  3
Skin and subcutaneous tissue disorders       
Dry skin   3/51 (5.88%)  3 3/50 (6.00%)  3 3/51 (5.88%)  3
Pruritus   8/51 (15.69%)  9 10/50 (20.00%)  11 7/51 (13.73%)  12
Vascular disorders       
Hypertension   2/51 (3.92%)  2 5/50 (10.00%)  6 2/51 (3.92%)  4
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director Clinical Operations
Organization: Innate Pharma
Phone: +33043030 ext 30
EMail: info@innate-pharma.fr
Layout table for additonal information
Responsible Party: Innate Pharma
ClinicalTrials.gov Identifier: NCT01687387    
Other Study ID Numbers: IPH2102-201
First Submitted: September 11, 2012
First Posted: September 18, 2012
Results First Submitted: December 15, 2017
Results First Posted: February 8, 2019
Last Update Posted: February 8, 2019