Trial · NCT05561387
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 | Progression free survival (PFS) of Arm 1 versus (vs.) Arm 2 | From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, or assessed up to 10 years | Analysis of each of the dual primary endpoints will be performed using a stratified log-rank test for comparison between arms. The analyses will be stratified according to frailty score (frail vs. intermediate fit), presence of one or more high-risk abnormalities by fluorescence in situ hybridization (iFISH) (yes vs. no), and prior therapy (yes vs. no). All eligible participants will be considered in analyses of the dual primary endpoints, according to their assigned arm at randomization. |
| Primary | Overall survival (OS) of Arm 1 vs. Arm 3 | From date of randomization to date of death due to any cause, or assessed up to 10 years | Analysis of each of the dual primary endpoints will be performed using a stratified log-rank test for comparison between arms. The analyses will be stratified according to frailty score (frail vs. intermediate fit), presence of one or more high-risk abnormalities by iFISH (yes vs. no), and prior therapy (yes vs. no). All eligible participants will be considered in analyses of the dual primary endpoints, according to their assigned arm at randomization. |
| Secondary | PFS | From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, or assessed up to 10 years | Analysis of PFS and OS endpoints will be performed using a stratified log-rank test for comparison between arms, with stratification according to frailty score (frail vs. intermediate fit) presence of one or more high-risk abnormalities by iFISH (yes vs. no) and prior therapy (yes vs. no). |
| Secondary | OS | From date of randomization to date of death due to any cause, or assessed up to 10 years | Analysis of PFS and OS endpoints will be performed using a stratified log-rank test for comparison between arms, with stratification according to frailty score (frail vs. intermediate fit) presence of one or more high-risk abnormalities by iFISH (yes vs. no) and prior therapy (yes vs. no). |
| Secondary | Overall response rate (ORR) | Up to 10 years | ORR is defined as the percentage of participants achieving a best response of partial response (PR) or better while on study. ORR will be reported with a binomial confidence interval. Time to response will be analyzed using the cumulative incidence competing risks method. |
| Secondary | Time to complete response (CR) | The time from the date of registration to the date of the first documented incidence of a response of CR or better, assessed up to 10 years | All eligible participants will be considered in analyses of the secondary endpoints, according to their assigned arm at randomization, and with participants who go off-study prior to response assessment considered as non-responders for the analysis of response rate and as censored at the time of removal from study for the analysis of time to response. Time to response will be analyzed using the cumulative incidence competing risks method. |
| Secondary | Time to very good partial response (VGFR) | The time from the date of registration to the date of the first documented incidence of a response of VGPR or better, assessed up to 10 years | All eligible participants will be considered in analyses of the secondary endpoints, according to their assigned arm at randomization, and with participants who go off-study prior to response assessment considered as non-responders for the analysis of response rate and as censored at the time of removal from study for the analysis of time to response. Time to response will be analyzed using the cumulative incidence competing risks method. |
| Secondary | Time to PR | The time from the date of registration to the date of the first documented incidence of a response of PR or better, assessed up to 10 years | All eligible participants will be considered in analyses of the secondary endpoints, according to their assigned arm at randomization, and with participants who go off-study prior to response assessment considered as non-responders for the analysis of response rate and as censored at the time of removal from study for the analysis of time to response. Time to response will be analyzed using the cumulative incidence competing risks method. |
| Secondary | Minimal residual disease (MRD) | At 9 months of induction therapy and 1 year of maintenance therapy | The rate of MRD negativity will be calculated at each timepoint as the number of patients who are MRD negative divided by the number of patients who were eligible, analyzable and assessable for clinical response assessment at that timepoint. Rates of MRD negativity will be compared using a two-arm binomial test. |
| Secondary | Patient report out comes (PRO) quality-of-life (QOL) | At baseline and months 1, 3, 9, and 18 after randomization | We will use the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 (version 3). This instrument includes questions broadly applicable to all cancer patients, assessing 5 functional domains (physical, role, cognitive, emotional, social) and 8 symptoms (fatigue, pain, nausea/vomiting, dyspnea, loss of appetite, insomnia, constipation, diarrhea), together with financial problems and global quality of life. |
| Secondary | Patient-reported toxicity (PRO-Common Terminology Criteria for Adverse Events [CTCAE]) | At baseline, at each treatment cycle up to month 18 from randomization, and at discontinuation of treatment | PRO-CTCAE is intended to enhance the quality of adverse event data reporting in clinical trials, provide data that complements and extends the information provided by clinician reporting using CTCAE, represent the patient perspective of the experience of symptomatic adverse events (AEs), and improve detection of potentially serious adverse events. Descriptive statistics will be used to summarize selected PRO-CTCAEs tabulated at each cycle overall and by arm. We will examine the extent to which PRO-CTCAEs with provider reported AEs are correlated and evaluate differences in incidence and worst severity. |
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.
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