Trial · NCT00184054
Trial of Arsenic Trioxide With Ascorbic Acid in the Treatment of Adult Non-Acute Promyelocytic Leukemia (APL) Acute Myelogenous Leukemia
NCT00184054, Phase 2, Terminated, University of Southern California; results first posted 2014-07-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Arsenic Trioxide With Ascorbic Acid in the Treatment of Adult Non-Acute Promyelocytic Leukemia (APL) Acute Myelogenous Leukemia. Trials, record NCT00184054. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00184054
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Arsenic Trioxide With Ascorbic Acid in the Treatment of Adult Non-Acute Promyelocytic Leukemia (APL) Acute Myelogenous Leukemia
- NCT number
- NCT00184054
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- University of Southern California
- Conditions
- Acute Myelogenous Leukemia
- Interventions
- Arsenic Trioxide (ATO), Ascorbic Acid
- First posted
- 2005-09-16
- Last updated
- 2014-07-25
- Results first posted
- 2014-07-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Response (Complete Remissions (CR) and Complete Remission With Incomplete Blood Count Recovery (CRi) | Up to 1 year | Complete Remission (CR): ANC \>=1000/mcl, Platelet count \>=100,000/mcl, Bone marrow \<5% blasts. Complete Remission with incomplete blood count recovery (CRi): Same as CR but ANC may be \<1,000/mcl and/or platelet count \<100,000/mcl. Patients who failed to achieve CR or CRi after two cycles were considered treatment failures. Patients who did not complete at least two cycles were not evaluated for response. |
| Secondary | Number of Participants With Severe (Grades 3-5) Adverse Events | Days 1, 8, 15, 21, 28, 35 of each cycle and at end of treatment (30 days after last dose or start of new therapy) | Patients who received any amount of ATO plus Ascorbic Acid are included in the safety analyses. |
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 | Number of Participants With a Response (Complete Remissions (CR) and Complete Remission With Incomplete Blood Count Recovery (CRi) | Up to 1 year | All subjects who received at least 2 cycles of treatment as part of this study are included in the analysis of response. | participants | NUMBER |
| SECONDARY | Number of Participants With Severe (Grades 3-5) Adverse Events | Days 1, 8, 15, 21, 28, 35 of each cycle and at end of treatment (30 days after last dose or start of new therapy) | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group11
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 a Response (Complete Remissions (CR) and Complete Remission With Incomplete Blood Count Recovery (CRi) | Arsenic Trioxide (ATO) Plus Ascorbic Acid | CR | 1 | participants | |
| Number of Participants With a Response (Complete Remissions (CR) and Complete Remission With Incomplete Blood Count Recovery (CRi) | Arsenic Trioxide (ATO) Plus Ascorbic Acid | CRi | 5 | participants | |
| Number of Participants With a Response (Complete Remissions (CR) and Complete Remission With Incomplete Blood Count Recovery (CRi) | Arsenic Trioxide (ATO) Plus Ascorbic Acid | Treatment Failure | 4 | participants | |
| Number of Participants With a Response (Complete Remissions (CR) and Complete Remission With Incomplete Blood Count Recovery (CRi) | Arsenic Trioxide (ATO) Plus Ascorbic Acid | Not Evaluable | 1 | participants | |
| Number of Participants With Severe (Grades 3-5) Adverse Events | Arsenic Trioxide (ATO) Plus Ascorbic Acid | Anorexia | 1 | Participants | |
| Number of Participants With Severe (Grades 3-5) Adverse Events | Arsenic Trioxide (ATO) Plus Ascorbic Acid | Alanine aminotransferase increased | 1 | Participants | |
| Number of Participants With Severe (Grades 3-5) Adverse Events | Arsenic Trioxide (ATO) Plus Ascorbic Acid | Conjunctivitis infective | 2 | Participants | |
| Number of Participants With Severe (Grades 3-5) Adverse Events | Arsenic Trioxide (ATO) Plus Ascorbic Acid | Differentiation syndrome | 1 | Participants | |
| Number of Participants With Severe (Grades 3-5) Adverse Events | Arsenic Trioxide (ATO) Plus Ascorbic Acid | Electrocardiogram QT corrected interval prolonged | 1 | Participants | |
| Number of Participants With Severe (Grades 3-5) Adverse Events | Arsenic Trioxide (ATO) Plus Ascorbic Acid | Neuropathy: sensory | 1 | Participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arsenic Trioxide (ATO) Plus Ascorbic Acid | 11 | |
| Overall Study | COMPLETED | Arsenic Trioxide (ATO) Plus Ascorbic Acid | 10 | |
| Overall Study | NOT COMPLETED | Arsenic Trioxide (ATO) Plus Ascorbic Acid | 1 |
Source ClinicalTrials.gov
Adverse events17
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 | Anorexia | Metabolism and nutrition disorders | Arsenic Trioxide (ATO) Plus Ascorbic Acid | 2 | 11 | 4 |
| other | Cellulitis - hand | Infections and infestations | Arsenic Trioxide (ATO) Plus Ascorbic Acid | 1 | 11 | 1 |
| other | Localized edema | General disorders | Arsenic Trioxide (ATO) Plus Ascorbic Acid | 2 | 11 | 2 |
| other | Electrocardiogram QT corrected interval prolonged | Investigations | Arsenic Trioxide (ATO) Plus Ascorbic Acid | 1 | 11 | 1 |
| other | Fatigue | General disorders | Arsenic Trioxide (ATO) Plus Ascorbic Acid | 3 | 11 | 3 |
| other | Headache | Nervous system disorders | Arsenic Trioxide (ATO) Plus Ascorbic Acid | 5 | 11 | 8 |
| other | Nausea | Gastrointestinal disorders | Arsenic Trioxide (ATO) Plus Ascorbic Acid | 5 | 11 | 10 |
| other | Rash maculo-papular | Skin and subcutaneous tissue disorders | Arsenic Trioxide (ATO) Plus Ascorbic Acid | 2 | 11 | 2 |
| other | Urinary Tract Infection | Infections and infestations | Arsenic Trioxide (ATO) Plus Ascorbic Acid | 1 | 11 | 1 |
| other | Vomiting | Gastrointestinal disorders | Arsenic Trioxide (ATO) Plus Ascorbic Acid | 5 | 11 | 10 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arsenic Trioxide (ATO) Plus Ascorbic Acid | ||
| Total, other adverse events | Arsenic Trioxide (ATO) Plus Ascorbic Acid | 11 | 11 |
| Total, serious adverse events | Arsenic Trioxide (ATO) Plus Ascorbic Acid | 11 | 11 |
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/NCT00184054
GET https://conductscience.org/api/trials/v1/NCT00184054/registered