Trial · NCT04833114
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assessment of the event-free survival of patients with DLBCL at first progression and the occurrence of any of the following events: | Day of randomization until end of follow up (12 weeks treatment and at least 21 months follow up) | * Failure to achieve sufficient response in PET-CT (Deauville score 3 or less) at end of study treatment (metabolic CR) * Disease progression (PD) * Start of additional unplanned anti-tumor treatment (radiation therapy allowed) * Relapse after achieving CR * Death due to any cause |
| Secondary | Assessment of the rate of metabolic complete response. | Day of randomization until end weeks 12 treatment. | Number of complete remissions. |
| Secondary | Evaluation of the partial response rate. | Day of randomization until end of 12 weeks treatment. | Number of partial responses. |
| Secondary | Assessment of the overall response rate. | Day of randomization until end of 12 weeks treatment. | Number of complete and partial responses. |
| Secondary | Assessment duration of response. | Day of randomization until end of follow up (12 weeks treatment and at least 21 months follow up) | Time from documentation of tumor response to disease progression or relapse. |
| Secondary | Assessment of the rate of progressive disease. | Day of randomization until end of 12 weeks treatment. | Number of progressive diseases. |
| Secondary | Assessment of disease relapse. | Day of randomization until end of 12 weeks treatment. | Number of relapses. |
| Secondary | Assessment of progression free survival. | Day of randomization until end of follow up (12 weeks treatment and at least 21 months follow up) | Occurence of disease progression, relapse or death due to any cause. |
| Secondary | Assessment of overall survival. | Day of randomization until end of follow up (12 weeks treatment and at least 21 months follow up) | |
| Secondary | Assessment of the rate of patients proceeding to transplantation. | Day of randomization until week 12. | |
| Secondary | Assessment of the rate of patients with non-relapse mortality. | Day of randomization until end of follow up (12 weeks treatment and at least 21 months follow up) | |
| Secondary | Evaluation of the frequency of adverse and serious adverse events including the incidence and duration of the adverse events neutropenia and thrombocytopenia with grade 4. | Day of Randomization until 28 days after start of last cycle or start of further therapy | |
| Secondary | Assessment of the number of patients with treatment-related death. | Day of Randomization until up week 12 or 2 months after week 12 but before start of further therapy | |
| Secondary | To determine the number of patients with occurence of second malignancies | Day of Randomization until Day of randomization until end of follow up (at least 21 months follow up) | |
| Secondary | Assessment of the protocol adherence by the rate and duration of chemotherapy cycles patients received. | Day of Randomizaton until week 12. | |
| Secondary | Assessment of the cumulative and relative dose of each IMP( ifosfamide, carboplatin and etoposide, rituximab and of the polatuzumab vedotin) by quantitative measurement. | Day of Randomizaton until week 12. | |
| Secondary | Assessment of the change in health related quality of life by generic questionnaire. | Day of Randomization until weeks 12 and months 3 and 12 in follow up. | Scale scores to be obtained for the multi-items scales. Range in score from 0 to 100. A high scale score represents a higher response level. |
| Secondary | Assessment of the change in health related quality of life by five-item questionnaire. | Day of Randomization until weeks 12 and months 3 and 12 in follow up | |
| Secondary | Assessment visual analogue scale to measure health state. | Day of Randomization until weeks 12 and months 3 and 12 in follow up | This scale is provided with numbers from 0 to 100.100 is the best health state and 0 (zero) is the worst health state. |
| Secondary | Functional assessment of the cancer therapy-lymphoma by general questions and specific questions for lymphoma. | Day of Randomization until weeks 12 and months 3 and 12 in follow up. | Assessment how lymphoma-specific symptoms impact quality of life. |
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/NCT04833114/registered