Trial · NCT06982274
Oral Arsenic With ATRA for Newly Diagnosed Patients With Acute Promyelocytic Leukemia
NCT06982274, Phase 2, Recruiting, Instituto do Cancer do Estado de São Paulo
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Oral Arsenic With ATRA for Newly Diagnosed Patients With Acute Promyelocytic Leukemia. Trials, record NCT06982274. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06982274
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral Arsenic With ATRA for Newly Diagnosed Patients With Acute Promyelocytic Leukemia
- NCT number
- NCT06982274
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 115 participants, estimated
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Conditions
- Acute Promyelocytic Leukemia (APL)
- Interventions
- Realgar-Indigo Naturalis Formulation
- First posted
- 2025-05-21
- Last updated
- 2025-05-30
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | 2 years | This endpoint includes death from any cause, including early death, death due to disease progression, or any death occurring after achieving complete remission. |
| Secondary | Complete hematologic response rate after induction. | 30 days | Absence of leukemic promyelocytes in the peripheral blood and bone marrow (\<5% blasts), recovery of normal blood counts (ANC ≥ 1.0 × 10⁹/L and platelets ≥ 100 × 10⁹/L), no extramedullary disease, and resolution of coagulopathy. |
| Secondary | Early death rate during induction | 30 days | Death before blood cell counts recovery during induction. |
| Secondary | Disease-free survival rate | 2 years | The proportion of patients who remain alive and in complete remission, without evidence of relapse, for at least two years following achievement of initial complete remission. |
| Secondary | Cumulative incidence of myelodysplasia and secondary leukemia | 5 years | The proportion of patients who develop myelodysplastic syndromes or secondary leukemia after treatment. |
| Secondary | Cumulative incidence of relapse | 2 years | The proportion of patients who experience a relapse of acute leukemia within two years of achieving complete remission, accounting for competing risk of death without relapse. |
| Secondary | Molecular remission rate after consolidation | 150 days | The proportion of patients who achieve a negative molecular test by PCR for PML-RARA after completing the consolidation phase of treatment. |
| Secondary | PML/RARA transcript level during treatment | Each 3 months | The quantitative measurement of the PML/RARA fusion gene transcript, assessed by PCR, at various stages of therapy. |
| Secondary | Days of hospitalization during treatment | 180 days | The total length of time a patient spends in the hospital for the administration of treatment, management of complications, or observation during the course of therapy. |
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.
Papers4
The papers the trial lists on ClinicalTrials.gov.
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/NCT06982274
GET https://conductscience.org/api/trials/v1/NCT06982274/registered