Trial · NCT05735834
Comparison Between Rituximab Plus Zanubrutinib Versus Rituximab Monotherapy in Untreated SMZL Patients
NCT05735834, Phase 3, Active not recruiting, International Extranodal Lymphoma Study Group (IELSG)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison Between Rituximab Plus Zanubrutinib Versus Rituximab Monotherapy in Untreated SMZL Patients. Trials, record NCT05735834. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05735834
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison Between Rituximab Plus Zanubrutinib Versus Rituximab Monotherapy in Untreated SMZL Patients
- NCT number
- NCT05735834
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 122 participants, actual
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)
- Conditions
- Splenic Marginal Zone Lymphoma
- Interventions
- Rituximab, Zanubrutinib
- First posted
- 2023-02-21
- Last updated
- 2026-07-22
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) rate at 3 years | From the date of randomization to the date of progression or the date of death from any cause until 3 years after randomization | PFS is defined as the time from the date of randomization until progression (assessed by the investigator per Lugano 2014 criteria) or death from any cause, whichever occurs first |
| Secondary | Complete remission rates - Lugano 2014 criteria | At 12 and 24 months after treatment start | Investigator-assessed complete remission rates achieved at 12 and 24 months of treatment, assessed according to the Lugano 2014 criteria |
| Secondary | Best response | From date of treatment start until 24 months after treatment start | Investigator-assessed best response achieved at any time during the treatment period (24 months) assessed according to the Lugano 2014 criteria |
| Secondary | Complete remission rates - Matutes criteria | At 12 and 24 months after treatment start | Investigator-assessed complete remission rates achieved at 12 and 24 months of treatment, assessed according to the Matutes criteria |
| Secondary | Best response - Matutes criteria | From date of treatment start until 24 months after treatment start | Investigator-assessed best response achieved at any time during the treatment period (24 months) assessed according to the Matutes criteria |
| Secondary | Time to next anti-lymphoma treatment (TTNT) | From the end of treatment to the start of the next anti-lymphoma therapy until 3 years after randomization | Investigator-assessed time to next anti-lymphoma treatment (TTNT) according to the Lugano 2014 criteria. TTNT is defined as time from the end of treatment until the start of the next therapy |
| Secondary | Duration of response (DoR) | From the time when criteria for response (ie, CR or PR) are met to the first documentation of relapse or progression until 3 years from randomization | Investigator-assessed DoR according to the Lugano 2014 criteria |
| Secondary | Overall Survival (OS) | From the time of randomization until death as a result of any cause until 3 years from randomization | OS according to the Lugano 2014 criteria. OS is defined as the time from random assignment until death as a result of any cause |
| Secondary | Treatment Emergent Adverse Events (AEs) | From the time of ICF signature until 28 days after treatment discontinuation or until resolution of all treatment-related AEs, whichever occurs later, or starting of a new anti-neoplastic treatment up to 3 years from randomization | Analysis of type and severity of adverse events (AEs) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40550489 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05735834
GET https://conductscience.org/api/trials/v1/NCT05735834/registered