Trial · NCT04263480
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | CR/VGPR | 12 months | Primary endpoint is the rate of CR or VGPR 12 months after the start of treatment using the response criteria updated at the Sixth IWWM (CR/VGPR). |
| Secondary | Response rate | 12/ 24 months | The response rates (CR, VGPR, PR, MR) and overall response rate (CR, VGPR, PR, MR) are evaluated 12 and 24 months after the start of treatment. |
| Secondary | Best response | 12 months | Best response (at least achieving a MR) is determined in the time interval from the start of induction therapy to end of follow-up. |
| Secondary | Time to best response | 12 months | Time to best response is defined as the time from the start of induction to best response the patient achieves (CR, VGPR, PR, MR). |
| Secondary | Time to first response | 12 months | Time to first response is defined as the time from the start of induction to first response (MR, PR, VGPR or CR). |
| Secondary | Time to treatment failure (TTF) | 7 years | TTF is defined as the time of start of induction treatment to discontinuation of therapy for any reason including death from any cause, progression, toxicity or add-on of new anti-cancer therapy. Patients alive without progression and relapse will be censored at the latest tumor assessment date. |
| Secondary | Remission duration (RD) | 7 years | Remission duration will be calculated in patients with response (CR, VGPR, PR, MR) from the date of response to the date of progression, relapse or death from any cause. Patients alive without progression and relapse will be censored at the latest tumor assessment date. |
| Secondary | Progression Free Survival (PFS) | 7 years | PFS will be calculated from the date of start of treatment to the following events: the date of progression (as defined in Appendix A) and the date of death if it occurred earlier. Patients alive without progression and relapse will be censored at the latest tumor assessment date. |
| Secondary | Cause specific survival (CSS) | 7 years | Cause specific survival is defined as the period from the start of induction treatment to death from lymphoma or lymphoma related cause; death unrelated to WM is considered as a competing event. |
| Secondary | Overall survival (OS) | 7 years | Overall survival is defined as the period from the start of induction treatment to death from any cause. Patients who have not died until the time of the analysis will be censored at their last contact date. |
| Secondary | Rate of Adverse Events (safety) | 7 years | Number of adverse events and comparison of adverse event rate in both treatment arms. |
| Secondary | Changes in Quality of Life | 7 years | Changes in quality of life will be assessed by the FACT-Lym questionnaire and compared in both treatment arms. |
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/NCT04263480/registered