Trial · NCT03589729
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of patients experiencing a decrease in left ventricular ejection fraction (LVEF) | Baseline up to 6 months | Will assess a decrease in LVEF of 10 percent from baseline or decrease in LVEF below the normal limit of 50% during treatment with dexrazoxane hydrochloride combined with cladribine, idarubicin, cytarabine, and gemtuzumab ozogamicin. |
| Secondary | Incidence of cardiac symptoms | Up to 1 year | Cardiac symptoms to be evaluated include: clinical heart failure, exertional dyspnea, orthopnea, S3 gallop, acute coronary syndrome, acute pulmonary edema and life-threatening arrhythmias |
| Secondary | Assessment of change in troponin I and high-sensitivity troponin T | Up to 1 year | Troponin levels will be collected before and after the day 1 dose of idarubicin each month during induction, consolidation, and maintenance therapy. |
| Secondary | Incidence of adverse events | Up to 1 year | |
| Secondary | Complete remission (CR) /complete remission with incomplete blood count recovery (CRi) rates (Cohorts 1-3) | Up to 1 year | |
| Secondary | Overall response (Cohorts 1-3) | Up to 1 year | |
| Secondary | Overall survival (Cohorts 1-3) | Up to 1 year | |
| Secondary | Event-free survival (Cohorts 1-3) | Up to 1 year | |
| Secondary | Remission duration (Cohorts 1-3) | Up to 1 year | |
| Secondary | Recurrence-free survival | Up to 6 months | The recurrence-free survival rate at 6 months will be a binary endpoint where the recurrence including death occurred within 6 months of treatment will be considered as "recurrence event". |
| Other | Assessment of metal chelation effects of dexrazoxane and chemotherapy | Up to 1 year | Metal chelation effects assessed by utilizing technologies commonly used in the geochemistry. |
| Other | Assessment of minimal residual disease (MRD) | Up to 1 year | Will explore the impact of MRD on relapse. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT03589729/registered