Trial · NCT05527340
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | Throught the study period. Approximately 6 years. | The percentage of participants with a confirmed partial response (PR) or better (PR, Very good partial response (VGPR), Complete response (CR), stringent complete response (sCR)).Response rates will be monitored monthly, but the study will report the % of patients achieving CR rate at month 12, 18, 24 and yearly thereafter. |
| Primary | Complete Response Rate (CRR) | Throught the study period. Approximately 6 years. | The percentage of participants with a confirmed complete response (CR) or better (stringent complete response (CR, sCR). |
| Secondary | Minimal Residual Disease (MRD) negativity rate | Throught the study period. Approximately 6 years. | The percentage of participants who are MRD negative by next-generation flow cytometry (NGF), PET/CT, and mass spectrometry. |
| Secondary | Progression-Free Survival (PFS) | Throught the study period. Approximately 6 years. | Time from the date of randomization until the earliest date of documented disease progression or death due to any cause. |
| Secondary | Overall Survival (OS) | Throught the study period. Approximately 6 years. | Time from the date of randomization until the date of death due to any cause |
| Secondary | Changes in the immune profiling. | Throught the study period. Approximately 6 years. | Relative distribution and immunophenotype of inmune profiling from baseline onto treatment, remission and disease progression. |
| Secondary | Health status/quality of life | Baseline and throught the first 24 months. | Global health status/quality of life based on patient reported outcome: EQ-5D/5L questionnaire. |
| Secondary | Health status/quality of life | Baseline and throught the first 24 months. | Global health status/quality of life based on patient reported outcome: QLQ-C30 questionnaire. |
| Secondary | Health status/quality of life | Baseline and throught the first 24 months. | Global health status/quality of life based on patient reported outcome: MY20 questionnaire. |
| Secondary | Frequency and percentage of deaths and primary cause of death. | Throught the study period. Approximately 6 years. | Incidence of deaths and primary cause of death for safety analysis. |
| Secondary | Incidence of adverse events (AEs). | Throught the treatment period. Approximately 4 years. | Incidence of adverse events (AEs). |
| Secondary | Percentage of patients discontinuing therapy due to AEs. | Throught the treatment period. Approximately 4 years. | Percentage of patients discontinuing therapy due to AEs. |
| Secondary | Percentage of patients requiring dose modifications. | Throught the treatment period. Approximately 4 years. | Percentage of patients requiring dose modifications. |
| Secondary | Percentage of patients with changes in laboratory analytes from the hematology and blood chemistry panel. | Throught the treatment period. Approximately 4 years. | Percentage of patients with changes in laboratory analytes from the hematology and blood chemistry panel. |
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/NCT05527340/registered