Trial · NCT04793919
Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia
NCT04793919, Phase 2, Recruiting, Associazione Italiana Ematologia Oncologia Pediatrica
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia. Trials, record NCT04793919. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04793919
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia
- NCT number
- NCT04793919
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 89 participants, estimated
- Lead sponsor
- Associazione Italiana Ematologia Oncologia Pediatrica
- Conditions
- Acute Promyelocytic Leukemia
- Interventions
- Mylotarg, Arsenic Trioxide, All-trans retinoic acid
- First posted
- 2021-03-11
- Last updated
- 2024-04-15
- Other registries' IDs
- eudract:2017-002383-40
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event Free Survival (EFS) probability | 3 years | SR patients: To evaluate the efficacy in terms of event-free survival of a treatment combining arsenic trioxide (ATO) and all-trans retinoic acid (ATRA) in newly diagnosed APL standard-risk children and adolescents HR patients: To evaluate the efficacy in terms of event-free survival of a treatment combining arsenic trioxide (ATO), all-trans retinoic acid (ATRA) and gemtuzumab ozogamicin (GO) in newly diagnosed APL high-risk children and adolescents |
| Secondary | Rate of hematological CR/CRi after induction | 5 years | To evaluate the rate of hematological Complete Remission (CR) (defined as bone marrow regenerating normal hematopoietic cells and containing \< 5% blast cells by morphology, with ANC in peripheral blood \> 1.0 x 10\^9/L and platelet count \> 100 x 10\^9/L) and Complete Remission with incomplete hematologic recovery (CRi) (defined as CR except that peripheral blood neutrophils and/or platelets do not meet the criteria as defined above) after induction therapy. |
| Secondary | Rate of molecular CR/CRi after induction | 5 years | To evaluate the rate of molecular CR/CRi (defined as the absence of PML/RARα fusion transcript in bone marrow assessed by RQ-PCR, with an assay sensitivity of at least 10\^-4). |
| Secondary | Rate of early death during induction | 5 years | To evaluate the rate of early death during induction (defined as any death occurring within 14 days from diagnosis from any cause). |
| Secondary | Probability of overall survival (OS) at 3 years | 3 years | To evaluate the rate of overall survival |
| Secondary | Cumulative incidence of relapse (CIR) at 3 years | 3 years | To evaluate the cumulative incidence of hematological relapse (defined as reappearance of promyeloblasts/abnormal promyelocytes \> 5% in the bone marrow) and molecular relapse (defined as reappearance of PML/RARα fusion transcript in two successive samples taken at least 2 weeks apart in patients previously in molecular remission). |
| Secondary | Incidence of hematological and non-hematological toxicity | 5 years | Incidence of treatment-related hematological and non-hematological toxicity assessed by CTCAE v4.0 |
| Secondary | Rate of molecular remission after 3 consolidation cycles | 5 years | To evaluate the rate of molecular remission (defined as the absence of PML/RARα fusion transcript in bone marrow assessed by RQ-PCR, with an assay sensitivity of at least 10\^-4) after 3 consolidation cycles. |
| Secondary | Assessment of PML/RARα transcription level reduction during treatment | 5 years | To evaluate the reduction of PML/RARα fusion transcript in bone marrow by means of RQ-PCR during treatment. |
| Secondary | Pediatric Quality of Life assessment | 5 years | Pediatric Quality of life assessed by PedsQoL questionnaire, in the questionnaire there is a list of things that might be a problem for the child. The minimum value is 0 (never a problem) - maximum value 4 (almost always problem) |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
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.
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.
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/NCT04793919
GET https://conductscience.org/api/trials/v1/NCT04793919/registered