Trial · NCT03484702
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) Per Independent Review Committee in Cohorts 1, 2 and 3 | From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months) | All participants in the JCAR017 treated set. Prespecified to be reported for cohorts 1,2, and 3 only. | Percent of Participants | NUMBER |
| PRIMARY | Overall Response Rate (ORR) Per Investigator in Cohort 4 | From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months) | All participants in the JCAR017 treated set. Prespecified to be reported for cohort 4 only. | Percent of Participants | NUMBER |
| PRIMARY | Overall Response Rate (ORR) Per Investigator in Cohort 5 | From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months) | All participants in the JCAR017 treated set. Prespecified to be reported for cohort 5 only. | Percent of Participants | NUMBER |
| PRIMARY | Number of Participants With Adverse Events in Cohort 7 | From leukapheresis to end of study (up to approximately 63 months) | All participants in the JCAR017 treated set. Prespecified to be reported for cohort 7 only | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs) in Cohort 7 | From leukapheresis to end of study (up to approximately 63 months) | All participants in the JCAR017 treated set. Prespecified to be reported for cohort 7 only | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7 | At Baseline and Day 29 after JCAR017 infusion | All participants in the JCAR017 treated set with available baseline and Day 29 hematology results. Prespecified to be reported for cohort 7 only | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7 | At Baseline and Day 29 after JCAR017 infusion | All participants in the JCAR017 treated set with available baseline and Day 29 serum chemistry results. Prespecified to be reported for cohort 7 only | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | From leukapheresis to end of study (up to approximately 63 months) | All participants in the JCAR017 treated set. Prespecified to be reported for Cohorts 1, 2, 3, 4, and 5 only | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | From leukapheresis to end of study (up to approximately 63 months) | All participants in the JCAR017 treated set. Prespecified to be reported for cohorts 1, 2, 3, 4, and 5 only | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | At Baseline and Day 29 after JCAR017 infusion | All participants in the JCAR017 treated set with available baseline and Day 29 hematology results. Prespecified to be reported for cohorts 1, 2, 3, 4, and 5 only | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | At Baseline and Day 29 after JCAR017 infusion | All participants in the JCAR017 treated set with available baseline and Day 29 serum chemistry results. Prespecified to be reported for cohorts 1, 2, 3, 4, and 5 only. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate (ORR) in Cohort 7 | From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months) | All participants in the JCAR017 treated set. Prespecified to be reported for cohort 7 only. | Percent of Participants | NUMBER |
| SECONDARY | Complete Response Rate (CRR) | From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months) | All participants in the JCAR017 treated set. | Percent of Participants | NUMBER |
| SECONDARY | Event Free Survival (EFS) | From JCAR017 infusion to death due to any reason, progressive disease, or starting a new anticancer therapy (up to approximately 63 months). | All participants in the JCAR017 treated set. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) Using European Medicines Agency (EMA) Criteria | From JCAR017 infusion to progressive disease or death due to any reason, whichever occurred first (up to approximately 63 months) | All participants in the JCAR017 treated set. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From the date of JCAR017 infusion to the date of death due to any reason (up to approximately 63 months). | All participants in the JCAR017 treated set. | Months | MEAN |
| SECONDARY | Duration of Response (DOR) | From JCAR017 infusion until disease progression, death due to any reason, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months) | All participants in the JCAR017 treated set who achieved a best overall response of complete response (and/ or CRu in cohort 5) or partial response/ remission. | Months | MEDIAN |
| SECONDARY | Maximum Concentration (Cmax) of JCAR017 by qPCR | At baseline and up until 24 months post JCAR017 infusion | All participants in the JCAR017 treated set with baseline and on-study PK measurements. | Copies/ug | GEOMETRIC_MEAN |
| SECONDARY | Time to Peak Concentration (Tmax) of JCAR017 by qPCR | At baseline and up until 24 months post JCAR017 infusion | All participants in the JCAR017 treated set with baseline and on-study PK measurements. | Days | MEDIAN |
| SECONDARY | Total Exposure to JCAR017 as Measured by Area Under the Curve (AUC) of JCAR017 by qPCR | At baseline and up until 24 months post JCAR017 infusion | All participants in the JCAR017 treated set with baseline and on-study PK measurements. | Days*copies/ug | GEOMETRIC_MEAN |
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.
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GET https://conductscience.org/api/trials/v1/NCT03484702/outcomes