Trial · NCT04027309
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overal survival (OS) | Approximately up to 70 months following first patient enrolment | Overall survival (OS), defined as the time from date of randomization to the date of death due to any cause. Patients still alive or lost to follow up will be censored at the time they were last known to be alive. |
| Secondary | Event-free survival (EFS) | Approximately up to 70 months following first patient enrolment | Event-free survival (EFS), defined as the time from randomization to failure to achieve CR after remission induction, death or relapse after achieving CR, whichever occurs first. A patient is said to have failed to achieve CR after remission induction if his/her best response during or at completion of the induction therapy is less than CR. Patients who achieved CR after remission induction and are not known to have relapsed or died will be censored at the date of last clinical assessment. CR is determined by the Investigator according to the European LeukemiaNet (ELN2017) recommended response criteria. |
| Secondary | CR rate after remission induction | Approximately up to 70 months following first patient enrolment | CR rate after remission induction is defined as the percentage of patients with best response of CR during or at completion of induction therapy. |
| Secondary | EFS with modified CR (mEFS) | Approximately up to 70 months following first patient enrolment | EFS with modified CR (mEFS) is defined similarly to EFS above. It is the time from randomization to failure to achieve CR after remission induction, death or relapse after achieving CR, whichever occurs first. However, a patient will be considered to have failed to achieve CR after remission induction if CR is not achieved within 60 days after the start of the last induction cycle. Patients who achieve CR within 60 days of the start of the last induction cycle and are not known to have relapsed or died will be censored at the date of last clinical assessment. |
| Secondary | CR and CRi rates after induction cycle 1 and after induction cycle 2 | Approximately up to 70 months following first patient enrolment | CR and CRi are determined by the Investigator based on the European LeukemiaNet (ELN2017) recommended response criteria. |
| Secondary | Relapse-free survival (RFS) after CR | Approximately up to 70 months following first patient enrolment | RFS is defined as time from the date of achievement of CR as determined by the Investigator until relapse or death from any cause, whichever comes first. Patients still in first CR and alive or lost to follow up will be censored at the date of last clinical assessment. |
| Secondary | Cumulative incidence of relapse (CIR) after CR | Approximately up to 70 months following first patient enrolment | CIR is measured from the date of achievement of CR as determined by the Investigator until the date of relapse. Patients not known to have relapsed will be censored on the date of last clinical assessment. Patients who died without relapse will be counted as a competing cause of failure. |
| Secondary | Cumulative incidence of death (CID) after CR | Approximately up to 70 months following first patient enrolment | CID is measured from the date of achievement of CR as determined by the Investigator until the date of death from any cause. Patients not known to have died will be censored on the date they were last known to be alive. Patients who experienced relapse in CR will be counted as competing cause of failure. |
| Secondary | CR without minimal residual disease (CRMRD-) rate after induction cycle 2 | Approximately up to 70 months following first patient enrolment | CRMRD- rate is defined as the percentage of patients who achieved CR as determined by the Investigator with no evidence of MRD |
| Secondary | CR or CRi without minimal residual disease (CR/CRiMRD-) rate after induction cycle 2 | Approximately up to 70 months following first patient enrolment | CR or CRi without minimal residual disease (CR/CRiMRD-) rate after induction cycle 2, defined as the percentage of patients who achieved CR or CRi as determined by the Investigator with no evidence of MRD |
| Secondary | Frequency and severity of adverse events according to CTCAE v5.0 | Continuously throughout the study, starting from informed consent until 30 days following the last administration of any study drug | Adverse events will be evaluated using the National Cancer Institute's Common Terminology Criteria for AEs (CTCAE) version 5.0 |
| Secondary | Time to hematopoietic recovery after each chemotherapy treatment cycle | Approximately up to 70 months following first patient enrolment | Time to hematopoietic recovery is defined as the time from the start of the cycle until recovery |
| Secondary | Allogeneic stem cell transplantation (allo-SCT) rate | Approximately up to 70 months following first patient enrolment | Allo-SCT rate is defined as the percentage of patients who underwent an allo-SCT |
| Secondary | Individual domain scores and visual analogue scale (VAS) score of the European Quality of Life 5 Dimensions (EQ-5D-5L) Questionnaire | At entry, 1st day of maintenance and every 3 months during maintenance until relapse or treatment discontinuation (approximately up to 70 months following first patient enrolment) | The EQ-5D-5L is a 5 item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today". Each domain has 5 levels. Each level has a 1 digit number expressing the level selected for that domain. These levels are summed up and the self-rated health is recorded on a 20 cm vertical, visual analogue scale, with endpoints labelled "the best health you can imagine" and "the worst health you can imagine". |
| Secondary | Individual subdomain scores and the global health status/QoL scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) | At entry, 1st day of maintenance and every 3 months during maintenance until relapse or treatment discontinuation (approximately up to 70 months following first patient enrolment) | The EORTC QLQ-C30 is a 30-item questionnaire that assesses 5 functional subdomains (physical functioning, role functioning, emotional functioning, cognitive functioning and social functioning), 1 global health status, 3 symptom subdomains (fatigue, nausea and vomiting and pain) and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most of the 30 items have 4 response levels (1="not at all", 2="a little", 3="quite a bit", and 4="very much"), with 2 questions relying on a 7-point numeric rating scale from 1="very poor" to 7="excellent". Raw scores are transformed into scale scores ranging from 0 to 100, with higher scores representing better functioning/QoL or worse symptom burden. |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04027309/registered