Trial · NCT01256073
A Safety and Tolerability Extension Trial Assessing Repeated Dosing of Anti-KIR (1-7F9) Human Monoclonal Antibody in Patients With Acute Myeloid Leukaemia
NCT01256073, Phase 1, Completed, Innate Pharma
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Safety and Tolerability Extension Trial Assessing Repeated Dosing of Anti-KIR (1-7F9) Human Monoclonal Antibody in Patients With Acute Myeloid Leukaemia. Trials, record NCT01256073. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01256073
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Tolerability Extension Trial Assessing Repeated Dosing of Anti-KIR (1-7F9) Human Monoclonal Antibody in Patients With Acute Myeloid Leukaemia
- NCT number
- NCT01256073
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 21 participants, actual
- Lead sponsor
- Innate Pharma
- Conditions
- Acute Myeloid Leukemia
- Interventions
- IPH2101
- First posted
- 2010-12-08
- Last updated
- 2014-02-28
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To assess safety and tolerability of repeating dosings of Anti-KIR(1-7F9) | every 2 weeks | using the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) |
| Secondary | To assess the pharmacokinetics upon repeated dosing(s)of Anti-KIR(1-7F9) | every 2 weeks | |
| Secondary | To assess the pharmacodynamics upon repeated dosing(s) of Anti-KIR(1-7F9) | every 2 or 4 weeks | * Degree of KIR-occupancy on patient NK-cells * Plasma inflammatory cytokines (IFN-γ, TNF-α, IL-1, IL-6) * Immunophenotyping (NK-, B- and T-lymphocyte counts and activation status) * NK-cell surface markers (activation markers and inhibitory receptors) * Functional assay of NK-cell activity only for patient from additional cohort |
| Secondary | To assess signs of efficacy of repeated dosing(s) with Anti-KIR(1-7F9) | to date of progression diagnosed or until death | * Reduction in minimal residual disease measured by WT-1 expression in blood and bone marrow * Progression-free survival (measured as calendar days from the first dosing of Anti-KIR(1-7F9) (in the IPH2101-101 trial) to date of progression diagnosed or until death by any cause * Overall survival measured as calendar days from the first dosing of Anti-KIR (1-7F9) to date of death |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT01256073
GET https://conductscience.org/api/trials/v1/NCT01256073/registered