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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Leukemia-Free Survival | from date of randomization until the date of first documented relapse, assessed up to 48 months | |
| Secondary | 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 | Number of Participants with Adverse Events based on full physical examination each treatment visit and collection of AEs |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Leukemia-Free Survival | from date of randomization until the date of first documented relapse, assessed up to 48 months | MONTHS | MEDIAN | |
| SECONDARY | 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 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Leukemia-Free Survival | IPH2102 at 1 mg/kg | 6.7 | 95% Confidence Interval 2.9 to 14.8 | MONTHS | |
| Leukemia-Free Survival | IPH2102 at 0.1 mg/kg | 17.6 | 95% Confidence Interval 11.2 to 25 | MONTHS | |
| Leukemia-Free Survival | Placebo (Normal Saline Solution) | 13.9 | 95% Confidence Interval 7.9 to 27.9 | MONTHS | |
| Number of Participants With Adverse Events | IPH2102 at 1 mg/kg | 43 | Participants | ||
| Number of Participants With Adverse Events | IPH2102 at 0.1 mg/kg | 49 | Participants | ||
| Number of Participants With Adverse Events | Placebo (Normal Saline Solution) | 47 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IPH2102 at 1 mg/kg | 51 | |
| Overall Study | STARTED | IPH2102 at 0.1 mg/kg | 50 | |
| Overall Study | STARTED | Placebo (Normal Saline Solution) | 51 | |
| Overall Study | COMPLETED | IPH2102 at 1 mg/kg | 10 | |
| Overall Study | COMPLETED | IPH2102 at 0.1 mg/kg | 12 | |
| Overall Study | COMPLETED | Placebo (Normal Saline Solution) | 13 | |
| Overall Study | NOT COMPLETED | IPH2102 at 1 mg/kg | 41 | |
| Overall Study | NOT COMPLETED | IPH2102 at 0.1 mg/kg | 38 | |
| Overall Study | NOT COMPLETED | Placebo (Normal Saline Solution) | 38 |
Source ClinicalTrials.gov
Adverse events288
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | IPH2102 at 1 mg/kg | 3 | 51 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | IPH2102 at 0.1 mg/kg | 5 | 50 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo (Normal Saline Solution) | 2 | 51 | 3 |
| other | Neutropenia | Blood and lymphatic system disorders | IPH2102 at 1 mg/kg | 4 | 51 | 9 |
| other | Neutropenia | Blood and lymphatic system disorders | IPH2102 at 0.1 mg/kg | 4 | 50 | 5 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo (Normal Saline Solution) | 5 | 51 | 11 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | IPH2102 at 1 mg/kg | 9 | 51 | 9 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | IPH2102 at 0.1 mg/kg | 7 | 50 | 11 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo (Normal Saline Solution) | 3 | 51 | 4 |
| other | Conjunctivitis | Eye disorders | IPH2102 at 1 mg/kg | 3 | 51 | 3 |
1 to 10 of 288Source ClinicalTrials.gov
See all 288 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IPH2102 at 1 mg/kg | 32 | 51 |
| Total, all-cause mortality | IPH2102 at 0.1 mg/kg | 26 | 50 |
| Total, all-cause mortality | Placebo (Normal Saline Solution) | 23 | 51 |
| Total, other adverse events | IPH2102 at 1 mg/kg | 38 | 51 |
| Total, other adverse events | IPH2102 at 0.1 mg/kg | 48 | 50 |
| Total, other adverse events | Placebo (Normal Saline Solution) | 43 | 51 |
| Total, serious adverse events | IPH2102 at 1 mg/kg | 12 | 51 |
| Total, serious adverse events | IPH2102 at 0.1 mg/kg | 17 | 50 |
| Total, serious adverse events | Placebo (Normal Saline Solution) | 11 | 51 |
Source ClinicalTrials.gov
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.
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