Trial · NCT06043674
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Complete Response (CR) Rate | Disease evaluation will be performed at 12, 24 and 36 weeks | Best Complete Response (CR) rate is defined as the proportion of participants achieving CR at any of the 3 timepoints (after 4, 8 and 12 cycles). CR is defined per Lugano 2014 criteria. |
| Secondary | Best Overall Response Rate (ORR) | Disease evaluation will be performed at 12, 24 and 36 weeks | Best Overall response rate (ORR) is defined as the proportion of participants achieving complete response (CR) or partial response (PR) at any of the 3 timepoints (after 4, 8 and 12 cycles). CR and PR are defined per Lugano 2014 criteria. |
| Secondary | Best Partial Response (PR) Rate | Disease evaluation will be performed at 12, 24 and 36 weeks | Best Partial response (PR) rate is defined as the proportion of participants achieving partial response at any of the 3 timepoints (after 4, 8, 12 cycles). PR is defined per Lugano 2014 criteria. |
| Secondary | Overall Response Rate at 36 weeks | 36 weeks | Overall response rate (ORR) at 36 weeks is defined as the proportion of participants who achieve complete response (CR) or partial response (PR) at the time of disease evaluation at 12 cycles (36 weeks). CR and PR are defined per Lugano 2014 criteria. |
| Secondary | Partial Response (PR) Rate at 36 weeks | 36 weeks | Partial Response (PR) rate at 36 weeks is defined as the proportion of participants achieving PR at the time of disease evaluation at 12 cycles (36 weeks). PR defined per Lugano 2014 criteria. |
| Secondary | Complete Response (CR) Rate at 36 weeks | 36 weeks | Complete Response (CR) rate at 36 weeks is defined as the proportion of participants achieving CR at the time of disease evaluation at 12 cycles (36 weeks). CR defined per Lugano 2014 criteria. |
| Secondary | Duration of Response (DOR) | Disease evaluation will be performed every 3 months, up to 2 years. | Duration of Response (DOR) is defined as the time from date of first documented confirmed objective response (CR + PR) to date of first documented progressive disease (PD) per Lugano 2014 criteria. |
| Secondary | Duration of Complete Response (DOCR) | In long-term follow-up, participants were assessed every 6 months, up to 2 years | Duration of complete response (DOCR) is defined as the time from date of first documented complete response to date of first documented progressive disease (PD) per Lugano 2014 criteria. |
| Secondary | Progression Free Survival (PFS) at 2 years | Participants will be followed up to 2 years. | PFS at 2 years is the percent probability estimate at 2 years based on the Kaplan-Meier method. PFS will be calculated as the time from start of treatment to the date of progressive disease (PD, defined per Lugano 2014 criteria), death, or last follow-up. Participants alive and progression-free at time of last follow-up will be censored. |
| Secondary | Median Progression Free Survival (PFS) | Participants will be followed up to 2 years. | PFS will be calculated as the time from start of treatment to the date of progressive disease (PD, defined per Lugano 2014 criteria), death, or last follow-up. Participants alive and progression-free at time of last follow-up will be censored. |
| Secondary | Overall Survival (OS) at 2 years | Participants will be followed up to 2 years. | OS at 2 years is the percent probability at 2 years based on Kaplan-Meier methodology. OS will be calculated as the time from the start of treatment to the date of death, or last follow-up. Participants alive at time of last follow-up will be censored. |
| Secondary | Median Overall Survival | Participants will be followed up to 10 years. | OS will be calculated as the time from the start of treatment to the date of death, or last follow-up. Participants alive at time of last follow-up will be censored. |
| Secondary | Minimal Residual Disease (MRD) Negativity | MRD testing will be performed every 3 months, up to 2 years, then every 6 months, up to 3 years (5 years in total) | MRD negativity is defined as the proportion of participants that achieve MRD negative, where it measured by multiparametric flow cytometry (Mayo Clinic Laboratories) or the clonoSEQ assay (Adaptive). |
| Secondary | Rate and severity of Cytokine Release Syndrome (CRS), immune effector cell-associated Neurotoxicity Syndrome (ICANS), and Hemophagocytic Lymphohistiocyotis (HLH) | Adverse events will be collected at each study visit plus 30 days post treatment end, up to 10 months. | CRS, ICANS, and HLH rates and severity will be summarized based on American Society of Transplantation and Cellular Therapy (ASTCT) Consensus grading. |
| Secondary | Tocilizumab Usage Rate | Within the first year on study | Tocilizumab usage rate is defined as the proportion of participants requiring tocilizumab usage of management of CRS. |
| Secondary | Median Tocilizumab Usage | Within the first year on study | Median tocilizumab usage is defined as median number of doses of tocilizumab administered per participant |
| Secondary | Grade 3-5 Adverse Events Rate | Adverse events will be collected at each study visit plus 30 days post treatment end | Grade 3-5 AE rate is defined as the proportion of patients who experienced grade 3-5 adverse event based on the Common Toxicity Criteria for Adverse Events version 5.0 as reported on case report form. |
| Secondary | Treatment-related Adverse Events Rate | Adverse events will be collected at each study visit plus 30 days post treatment end | Treatment-related adverse event rate is defined as the proportion of participants who experienced treatment-related adverse event based on the Common Toxicity Criteria for Adverse Events version 5.0. |
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/NCT06043674/registered