Trial · NCT06594939
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 | Complete Response | Up to six months. | This is defined as the number of subjects achieving a complete response at the end of treatment using the Lugano criteria. |
| Secondary | Partial Response | Up to six months | This is defined as the number of subjects achieving a partial response at the end of treatment using the Lugano criteria. |
| Secondary | Duration of Response | Up to 60 months | This is defined as the time from the first documentation of tumor response to disease progression (per the Lugano criteria), relapse, or death among patients who achieve a response of partial response or better. The measure will be the median duration of response in months. |
| Secondary | Overall Survival | 2 years | This outcome measure is the number of subjects expiring from any cause. |
| Secondary | Adverse Events | Up to 7 months | The number of grade 3 or higher adverse events possibly, probably, or definitely related to study therapy in the safety run-in population from the start of therapy through 30 days after the end of study therapy. Adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, version 5.0. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded using the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading system described by Lee et al., 2019. The scale for ICANS will be the ASTCT ICANS consensus grading for adults. The score evaluates neurotoxicity domains. The lowest grade is 1 (less severe) and the highest is 4 (more severe). The ASTCT Consensus Grading for CRS, is based on the severity of the patient's symptoms. The lowest grade is 1 and the highest is 4. The higher the grade, the more severe. |
| Secondary | Study therapy completion | Up to 6 months | The number of subjects who complete the study therapy. |
| Secondary | Eligibility for abbreviated therapy | 56 days | The number of subjects eligible for abbreviated therapy. |
| Secondary | Eligibility for full therapy | 56 days | The number of subjects eligible for full therapy. |
| Secondary | CRS or ICANS | 28 days | The number of subjects experiencing a CRS or ICANS of the total study population within the first 28 days after study therapy start. The scale for ICANS will be the ASTCT ICANS consensus grading for adults. The score evaluates various neurotoxicity domains. The lowest grade is 1 and the highest is 4. The higher the grade, the more severe the symptoms. The scale for CRS, ASTCT Consensus Grading for CRS, is based on the severity of the patient's symptoms. The lowest grade is 1 and the highest is 4. The higher the grade, the more severe the symptoms. |
| Secondary | Minimal residual disease at Cycle 3 | 56 days | The number of subjects who achieve minimal residual disease negativity at Cycle 3. This will be determined using the clonoSEQ assay. |
| Secondary | Minimal residual disease at end of study treatment | Up to six monts | The number of subjects who achieve minimal residual disease negativity at the end of treatment. This will be determined using the clonoSEQ assay. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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/NCT06594939/registered