Trial · NCT04793919
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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) |
| Secondary | Total hospitalization days during therapy | 5 years | Number of total hospitalization days during the treatment. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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.
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