Trial · NCT03318016
Arsenic Trioxide With Cyclophosphamide in Patients With Relapsed/Refractory Acute Myeloid Leukemia
NCT03318016, Phase 1, Terminated, University of Colorado, Denver; results first posted 2024-08-01
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Arsenic Trioxide With Cyclophosphamide in Patients With Relapsed/Refractory Acute Myeloid Leukemia. Trials, record NCT03318016. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03318016
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Arsenic Trioxide With Cyclophosphamide in Patients With Relapsed/Refractory Acute Myeloid Leukemia
- NCT number
- NCT03318016
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 5 participants, actual
- Lead sponsor
- University of Colorado, Denver
- Conditions
- Acute Myeloid Leukemia, Relapsed/Refractory Acute Myeloid Leukemia
- Interventions
- Cyclophosphamide 500 MG, Cyclophosphamide 1000 MG, Cyclophosphamide 2000 MG, Cyclophosphamide 3000 MG, Cyclophosphamide 4000 MG
- First posted
- 2017-10-23
- Last updated
- 2024-08-01
- Results first posted
- 2024-08-01
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 That Reached Maximally Tolerated Dose (MTD) of Cyclophosphamide and ATO | 26 months | Number of Participants that were treated in each Cohort in attempt to establish Maximally Tolerated Dose (MTD) of cyclophosphamide with ATO is defined as the highest dose level of 1000 mg/m2. MTD is established when at least 6 participants within a Cohort have responded without toxicity. The trial is organized in a standard, phase I, 3+3 design. The first 3 subjects will be assigned to cohort 1. Per standard trial design, if there are 0/3 dose-limiting toxicities (DLT) in this cohort, the next three subjects will be assigned to cohort 2. This will continue until MTD is established. |
| Secondary | Overall Response Rate (ORR) Using ATO and Cyclophosphamide | 26 months | ORR defined by complete remission/complete remission with incomplete recovery of blood counts (CR/CRi), morphologic leukemia free state (MLFS) and partial responses (PR) |
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 That Reached Maximally Tolerated Dose (MTD) of Cyclophosphamide and ATO | 26 months | Patients With Relapsed/Refractory Acute Myeloid Leukemia | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate (ORR) Using ATO and Cyclophosphamide | 26 months | Subjects provided both ATO and Cyclophosphamide | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants That Reached Maximally Tolerated Dose (MTD) of Cyclophosphamide and ATO | Cohort -1 | 0 | Participants | ||
| Number of Participants That Reached Maximally Tolerated Dose (MTD) of Cyclophosphamide and ATO | Cohort 1 | 0 | Participants | ||
| Number of Participants That Reached Maximally Tolerated Dose (MTD) of Cyclophosphamide and ATO | Cohort 2 | 0 | Participants | ||
| Number of Participants That Reached Maximally Tolerated Dose (MTD) of Cyclophosphamide and ATO | Cohort 3 | 0 | Participants | ||
| Number of Participants That Reached Maximally Tolerated Dose (MTD) of Cyclophosphamide and ATO | Cohort 4 | 0 | Participants | ||
| Overall Response Rate (ORR) Using ATO and Cyclophosphamide | Cohort 1 | 3 | Participants | ||
| Overall Response Rate (ORR) Using ATO and Cyclophosphamide | Cohort 2 | 2 | Participants |
Source ClinicalTrials.gov
Participant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort -1 | 0 | |
| Overall Study | STARTED | Cohort 1 | 3 | |
| Overall Study | STARTED | Cohort 2 | 2 | |
| Overall Study | STARTED | Cohort 3 | 0 | |
| Overall Study | STARTED | Cohort 4 | 0 | |
| Overall Study | COMPLETED | Cohort -1 | 0 | |
| Overall Study | COMPLETED | Cohort 1 | 3 | |
| Overall Study | COMPLETED | Cohort 2 | 2 | |
| Overall Study | COMPLETED | Cohort 3 | 0 | |
| Overall Study | COMPLETED | Cohort 4 | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events200
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 | Activity Change | General disorders | Cohort -1 | 0 | ||
| other | Activity Change | General disorders | Cohort 1 | 1 | 3 | 1 |
| other | Activity Change | General disorders | Cohort 2 | 0 | 2 | 0 |
| other | Activity Change | General disorders | Cohort 3 | 0 | ||
| other | Activity Change | General disorders | Cohort 4 | 0 | ||
| other | Pain | Musculoskeletal and connective tissue disorders | Cohort -1 | 0 | ||
| other | Pain | Musculoskeletal and connective tissue disorders | Cohort 1 | 1 | 3 | 1 |
| other | Pain | Musculoskeletal and connective tissue disorders | Cohort 2 | 1 | 2 | 1 |
| other | Pain | Musculoskeletal and connective tissue disorders | Cohort 3 | 0 | ||
| other | Pain | Musculoskeletal and connective tissue disorders | Cohort 4 | 0 |
1 to 10 of 200Source ClinicalTrials.gov
See all 200 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort -1 | 0 | 0 |
| Total, all-cause mortality | Cohort 1 | 0 | 3 |
| Total, all-cause mortality | Cohort 2 | 0 | 2 |
| Total, all-cause mortality | Cohort 3 | 0 | 0 |
| Total, all-cause mortality | Cohort 4 | 0 | 0 |
| Total, other adverse events | Cohort -1 | 0 | 0 |
| Total, other adverse events | Cohort 1 | 3 | 3 |
| Total, other adverse events | Cohort 2 | 2 | 2 |
| Total, other adverse events | Cohort 3 | 0 | 0 |
| Total, other adverse events | Cohort 4 | 0 | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
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.
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/NCT03318016
GET https://conductscience.org/api/trials/v1/NCT03318016/events?page=2