Trial · NCT00413166
All-trans Retinoic Acid, and Arsenic +/- Idarubicin
NCT00413166, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2019-04-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. All-trans Retinoic Acid, and Arsenic +/- Idarubicin. Trials, record NCT00413166. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00413166
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- All-trans Retinoic Acid, and Arsenic +/- Idarubicin
- NCT number
- NCT00413166
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 78 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Acute Promyelocytic Leukemia
- Interventions
- All-Trans Retinoic Acid (ATRA), Arsenic Trioxide (ATO), Idarubicin, Gemtuzumab Ozogamicin
- First posted
- 2006-12-19
- Last updated
- 2019-05-07
- Results first posted
- 2019-04-18
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response (CR) Rate | 1 month, up to day 85 of treatment | Response defined as CR (marrow with \<5% blasts and no abnormal promyelocytes together with neutrophil count \>1000 and platelet count \>100,000) and toxicity as Acute promyelocytic leukemia (APL) differentiation syndrome, arrhythmia, peripheral neuropathy. Bone marrow aspirate performed to check the status of the disease. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Response (CR) Rate | 1 month, up to day 85 of treatment | Of the 57 participants treated on the ATRA + ATO: Low Risk treatment arm, 56 participants were evaluable for response. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Response (CR) Rate | ATRA + ATO: Low Risk (WBC<10,000) | 55 | Participants | ||
| Complete Response (CR) Rate | ATRA+ATO+IDA: High Risk (WBC >10,000) | 5 | Participants | ||
| Complete Response (CR) Rate | ATO+ATRA+GO | 15 | 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 | ATRA + ATO: Low Risk (WBC<10,000) | 57 | |
| Overall Study | STARTED | ATRA+ATO+IDA: High Risk (WBC >10,000) | 5 | |
| Overall Study | STARTED | ATO+ATRA+GO | 16 | |
| Overall Study | COMPLETED | ATRA + ATO: Low Risk (WBC<10,000) | 57 | |
| Overall Study | COMPLETED | ATRA+ATO+IDA: High Risk (WBC >10,000) | 5 | |
| Overall Study | COMPLETED | ATO+ATRA+GO | 16 | |
| Overall Study | NOT COMPLETED | ATRA + ATO: Low Risk (WBC<10,000) | 0 | |
| Overall Study | NOT COMPLETED | ATRA+ATO+IDA: High Risk (WBC >10,000) | 0 | |
| Overall Study | NOT COMPLETED | ATO+ATRA+GO | 0 |
Source ClinicalTrials.gov
Adverse events87
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 | Infection | Infections and infestations | ATRA + ATO: Low Risk (WBC<10,000) | 5 | 57 | 5 |
| other | Infection | Infections and infestations | ATRA+ATO+IDA: High Risk (WBC >10,000) | 0 | 5 | 0 |
| other | Infection | Infections and infestations | ATO+ATRA+GO | 1 | 16 | 1 |
| serious | Appendectomy | Gastrointestinal disorders | ATRA + ATO: Low Risk (WBC<10,000) | 1 | 57 | 1 |
| serious | Appendectomy | Gastrointestinal disorders | ATRA+ATO+IDA: High Risk (WBC >10,000) | 0 | 5 | 0 |
| serious | Appendectomy | Gastrointestinal disorders | ATO+ATRA+GO | 0 | 16 | 0 |
| serious | Cardiac Troponin I | Cardiac disorders | ATRA + ATO: Low Risk (WBC<10,000) | 1 | 57 | 1 |
| serious | Cardiac Troponin I | Cardiac disorders | ATRA+ATO+IDA: High Risk (WBC >10,000) | 0 | 5 | 0 |
| serious | Cardiac Troponin I | Cardiac disorders | ATO+ATRA+GO | 0 | 16 | 0 |
| serious | Chest Pain | Cardiac disorders | ATRA + ATO: Low Risk (WBC<10,000) | 1 | 57 | 1 |
1 to 10 of 87Source ClinicalTrials.gov
See all 87 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ATRA + ATO: Low Risk (WBC<10,000) | 1 | 57 |
| Total, all-cause mortality | ATRA+ATO+IDA: High Risk (WBC >10,000) | 0 | 5 |
| Total, all-cause mortality | ATO+ATRA+GO | 1 | 16 |
| Total, other adverse events | ATRA + ATO: Low Risk (WBC<10,000) | 5 | 57 |
| Total, other adverse events | ATRA+ATO+IDA: High Risk (WBC >10,000) | 0 | 5 |
| Total, other adverse events | ATO+ATRA+GO | 1 | 16 |
| Total, serious adverse events | ATRA + ATO: Low Risk (WBC<10,000) | 22 | 57 |
| Total, serious adverse events | ATRA+ATO+IDA: High Risk (WBC >10,000) | 4 | 5 |
| Total, serious adverse events | ATO+ATRA+GO | 4 | 16 |
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/NCT00413166
GET https://conductscience.org/api/trials/v1/NCT00413166/events?page=2