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Trial · NCT01687387

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

NCT01687387, Phase 2, Completed, Innate Pharma; results first posted 2019-02-08

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Efficacy Study of Anti-KIR Monoclonal Antibody as Maintenance Treatment in Acute Myeloid Leukemia (EFFIKIR). Trials, record NCT01687387. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01687387

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Efficacy Study of Anti-KIR Monoclonal Antibody as Maintenance Treatment in Acute Myeloid Leukemia (EFFIKIR)
NCT number
NCT01687387
Status
Completed
Phases
Phase 2
Enrollment
152 participants, actual
Lead sponsor
Innate Pharma
Conditions
Acute Myeloid Leukemia
Interventions
IPH2102 at 0.1 mg/kg, IPH2102 at 1 mg/kg, Placebo (normal saline solution)
First posted
2012-09-18
Last updated
2019-02-08
Results first posted
2019-02-08

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryLeukemia-Free Survivalfrom date of randomization until the date of first documented relapse, assessed up to 48 months
SecondaryNumber of Participants With Adverse Eventsfrom 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 monthsNumber of Participants with Adverse Events based on full physical examination each treatment visit and collection of AEs

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYLeukemia-Free Survivalfrom date of randomization until the date of first documented relapse, assessed up to 48 monthsMONTHSMEDIAN
SECONDARYNumber of Participants With Adverse Eventsfrom 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 monthsParticipantsCOUNT_OF_PARTICIPANTS

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Leukemia-Free SurvivalIPH2102 at 1 mg/kg6.795% Confidence Interval 2.9 to 14.8MONTHS
Leukemia-Free SurvivalIPH2102 at 0.1 mg/kg17.695% Confidence Interval 11.2 to 25MONTHS
Leukemia-Free SurvivalPlacebo (Normal Saline Solution)13.995% Confidence Interval 7.9 to 27.9MONTHS
Number of Participants With Adverse EventsIPH2102 at 1 mg/kg43Participants
Number of Participants With Adverse EventsIPH2102 at 0.1 mg/kg49Participants
Number of Participants With Adverse EventsPlacebo (Normal Saline Solution)47Participants

Participant flow9

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDIPH2102 at 1 mg/kg51
Overall StudySTARTEDIPH2102 at 0.1 mg/kg50
Overall StudySTARTEDPlacebo (Normal Saline Solution)51
Overall StudyCOMPLETEDIPH2102 at 1 mg/kg10
Overall StudyCOMPLETEDIPH2102 at 0.1 mg/kg12
Overall StudyCOMPLETEDPlacebo (Normal Saline Solution)13
Overall StudyNOT COMPLETEDIPH2102 at 1 mg/kg41
Overall StudyNOT COMPLETEDIPH2102 at 0.1 mg/kg38
Overall StudyNOT COMPLETEDPlacebo (Normal Saline Solution)38

Adverse events288

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherAnaemiaBlood and lymphatic system disordersIPH2102 at 1 mg/kg3513
otherAnaemiaBlood and lymphatic system disordersIPH2102 at 0.1 mg/kg5505
otherAnaemiaBlood and lymphatic system disordersPlacebo (Normal Saline Solution)2513
otherNeutropeniaBlood and lymphatic system disordersIPH2102 at 1 mg/kg4519
otherNeutropeniaBlood and lymphatic system disordersIPH2102 at 0.1 mg/kg4505
otherNeutropeniaBlood and lymphatic system disordersPlacebo (Normal Saline Solution)55111
otherThrombocytopeniaBlood and lymphatic system disordersIPH2102 at 1 mg/kg9519
otherThrombocytopeniaBlood and lymphatic system disordersIPH2102 at 0.1 mg/kg75011
otherThrombocytopeniaBlood and lymphatic system disordersPlacebo (Normal Saline Solution)3514
otherConjunctivitisEye disordersIPH2102 at 1 mg/kg3513

Adverse event totals9

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityIPH2102 at 1 mg/kg3251
Total, all-cause mortalityIPH2102 at 0.1 mg/kg2650
Total, all-cause mortalityPlacebo (Normal Saline Solution)2351
Total, other adverse eventsIPH2102 at 1 mg/kg3851
Total, other adverse eventsIPH2102 at 0.1 mg/kg4850
Total, other adverse eventsPlacebo (Normal Saline Solution)4351
Total, serious adverse eventsIPH2102 at 1 mg/kg1251
Total, serious adverse eventsIPH2102 at 0.1 mg/kg1750
Total, serious adverse eventsPlacebo (Normal Saline Solution)1151

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01687387

GET https://conductscience.org/api/trials/v1/NCT01687387/events?page=2