Trial · NCT02966301
Treatment of Chronic Graft Versus Host Disease With Arsenic Trioxide
NCT02966301, Phase 2, Completed, Medsenic; results first posted 2022-05-09
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Treatment of Chronic Graft Versus Host Disease With Arsenic Trioxide. Trials, record NCT02966301. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02966301
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Chronic Graft Versus Host Disease With Arsenic Trioxide
- NCT number
- NCT02966301
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- Medsenic
- Conditions
- Chronic Graft-Versus-Host Disease, Immune System Diseases
- Interventions
- Arsenic Trioxide Injectable Solution
- First posted
- 2016-11-17
- Last updated
- 2022-05-09
- Results first posted
- 2022-05-09
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Complete or Partial Remission of Chronic Graft Versus Host Disease After a First Line Treatment With Arsenic Trioxide | six months | Clinical response will be evaluated based on the Working Group Report 2015, published by the National Institute of Health Consensus. Response definition is as follows: * Complete remission (CR) is defined as complete disappearance of any sign of chronic GvHD. * Partial remission (PR) is defined as a significant improvement as defined by the organ or site specific measurement scale without progression in any other organ or site. |
| Secondary | Average Dose of Corticosteroids | Average dose of Prednisone at 6 months after the first infusion of ATO | Average dose in mg/kg/day of prednisone or prednisone equivalent |
| Secondary | Failure Free Survival | 6 months after first ATO infusion | Treatment failure were defined by: * Initiation of a new systemic treatment for chronic GvHD; * Recurrent or progressive malignancy; * Death |
| Secondary | Number of Adverse Events | 12 months after the first infusion of ATO for each patient | Tolerability and safety of ATO in combination with Prednisone, with or without Ciclosporine, in patients with chronic GvHD after allo-SCT. Adverse events follow-up for all patients throughout the study |
| Secondary | Cumulative Incidence for Non-relapse Mortality (NRM) | 12 months after first ATO infusion | Non-Relapse Mortality (NRM) of infectious and non-infectious origin |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Complete or Partial Remission of Chronic Graft Versus Host Disease After a First Line Treatment With Arsenic Trioxide | six months | All patients who entered the study, completed their first cycle of ATO and for whom the response at Week 6 after diagnosis of chronic GvHD has been evaluated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Average Dose of Corticosteroids | Average dose of Prednisone at 6 months after the first infusion of ATO | All patients who entered the study, completed their first cycle of ATO and for whom the response at Week 6 after diagnosis of chronic GvHD has been evaluated. | mg/kg/day | MEAN |
| SECONDARY | Failure Free Survival | 6 months after first ATO infusion | FAS | percentage of participants | NUMBER |
| SECONDARY | Number of Adverse Events | 12 months after the first infusion of ATO for each patient | Safety Analysis Population | number of events | NUMBER |
| SECONDARY | Cumulative Incidence for Non-relapse Mortality (NRM) | 12 months after first ATO infusion | FAS | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Complete or Partial Remission of Chronic Graft Versus Host Disease After a First Line Treatment With Arsenic Trioxide | Interventional | 15 | Participants | ||
| Average Dose of Corticosteroids | Interventional | 0.22 | Standard Deviation 0.29 | mg/kg/day | |
| Failure Free Survival | Interventional | 90 | 95% Confidence Interval 65.6 to 97.4 | percentage of participants | |
| Number of Adverse Events | Interventional | 197 | number of events | ||
| Cumulative Incidence for Non-relapse Mortality (NRM) | Interventional | 5 | 95% Confidence Interval 0.3 to 21.1 | percentage of participants |
Source ClinicalTrials.gov
Participant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arsenic Trioxide Injectable Solution | 21 | |
| Overall Study | Full Analysis Set (FAS) | Arsenic Trioxide Injectable Solution | 20 | |
| Overall Study | Safety Analysis (SA) | Arsenic Trioxide Injectable Solution | 21 | |
| Overall Study | COMPLETED | Arsenic Trioxide Injectable Solution | 18 | |
| Overall Study | NOT COMPLETED | Arsenic Trioxide Injectable Solution | 3 |
Source ClinicalTrials.gov
Adverse events121
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 | Hyperaemia | Vascular disorders | Arsenic Trioxide Infusion | 1 | 21 | 2 |
| other | Hypertension | Vascular disorders | Arsenic Trioxide Infusion | 1 | 21 | 1 |
| other | Thrombosis | Vascular disorders | Arsenic Trioxide Infusion | 1 | 21 | 1 |
| other | Venous thrombosis | Vascular disorders | Arsenic Trioxide Infusion | 1 | 21 | 1 |
| other | Drug hypersensitivity | Immune system disorders | Arsenic Trioxide Infusion | 1 | 21 | 1 |
| other | Hypogammaglobulinaemia | Immune system disorders | Arsenic Trioxide Infusion | 2 | 21 | 2 |
| other | Asthenia | General disorders | Arsenic Trioxide Infusion | 3 | 21 | 3 |
| other | Chest pain | General disorders | Arsenic Trioxide Infusion | 1 | 21 | 1 |
| other | Cyst | General disorders | Arsenic Trioxide Infusion | 1 | 21 | 1 |
| other | Face oedema | General disorders | Arsenic Trioxide Infusion | 1 | 21 | 1 |
1 to 10 of 121Source ClinicalTrials.gov
See all 121 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arsenic Trioxide Infusion | 2 | 21 |
| Total, other adverse events | Arsenic Trioxide Infusion | 21 | 21 |
| Total, serious adverse events | Arsenic Trioxide Infusion | 21 | 21 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35830931 | DERIVED |
Source PubMed
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT02966301
GET https://conductscience.org/api/trials/v1/NCT02966301/events?page=2