Trial · NCT07208981
Orelabrutinib Combined With Zebetuzumab and Lenalidomide for the Treatment of Newly Diagnosed MZL
NCT07208981, Phase 2, Recruiting, The First Affiliated Hospital with Nanjing Medical University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Orelabrutinib Combined With Zebetuzumab and Lenalidomide for the Treatment of Newly Diagnosed MZL. Trials, record NCT07208981. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07208981
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Orelabrutinib Combined With Zebetuzumab and Lenalidomide for the Treatment of Newly Diagnosed MZL
- NCT number
- NCT07208981
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 169 participants, estimated
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Conditions
- Marginal Zone Lymphoma(MZL)
- Interventions
- Orelabrutinib, Zebetuzumab, Lenalidomide, Bendamustine + Rituximab
- First posted
- 2025-10-06
- Last updated
- 2025-10-06
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 3-year PFS rate | From the first dose of treatment to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 66 months. | PFS is defined as the first dose of treatment to the date of first documented progression or date of death from any cause, whichever occurs first. 3-year PFS rate will be estimated by Kaplan-Meier. |
| Secondary | Overall response rate (ORR) | On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 13, Day 1 of Cycle 19, Day 1 of Cycle 25, Day 1 of Cycle 31 (each cycle is 28 days). | Overall response rate is the proportion of patients who achieve either a complete or partial response to treatment defined by the Lugano classification criteria for lymphoma response evaluation (2014 edition)/GELA (gastric MALT). |
| Secondary | Rate of best overall response (BOR) | On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 13, Day 1 of Cycle 19, Day 1 of Cycle 25, Day 1 of Cycle 31 (each cycle is 28 days). | The rate of best overall response is the proportion of patients who achieve their best recorded response (complete or partial) to treatment at any time during the study. |
| Secondary | Time to response (TTR) | On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 13, Day 1 of Cycle 19, Day 1 of Cycle 25, Day 1 of Cycle 31 (each cycle is 28 days). | Time to response is the duration from the start of treatment to the first documentation of a complete or partial response. |
| Secondary | Progression-free survival (PFS) rate | From the first dose of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 66 months. | PFS is defined as the time from the first dose of treatment until the date of first documented progression or date of death from any cause, whichever occurs first. For subjects without progression, relapse, or death at the time of analysis, EFS will be censored at the last assessment date. |
| Secondary | Overall survival (OS) rate | From the first dose of treatment until the date of death from any cause, assessed up to 66 months. | OS is defined as the time from the first dose of treatment until the date of death from any cause, assessed up to 66 months. Subjects who remain alive at the time of analysis will be censored at the last known alive date of the subject. |
| Secondary | Rate of progression of disease within 24 months (POD24) | On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 13, Day 1 of Cycle 19, Day 1 of Cycle 25, Day 1 of Cycle 31 (each cycle is 28 days). | Progression of disease within 24 months is defined as patients whose disease relapse or progress within 24 months of first treatment. |
| Secondary | Quality of life (FACT-Lym) | On Screening, Day 1 of Cycle 1, Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 13, Day 1 of Cycle 19, Day 1 of Cycle 25, Day 1 of Cycle 31 (each cycle is 28 days). | FACT-Lym (Functional Assessment of Cancer Therapy-Lymphoma) is a validated questionnaire that measures health-related quality of life in patients with lymphoma, covering physical, social/family, emotional, and functional well-being, along with lymphoma-specific symptoms and concerns. FACT-Lym has 42 items, and scores of every item range from 0 to 4, with higher scores indicating better quality of life. |
| Secondary | Adverse Events | From screening to 3 years after the end of maintenance therapy. | All treatment-emergent AEs will be included in the analysis. For each AE, the number and percentage of subjects who experience at least one occurrence of the given event will be summarized. The number and percent of subjects with TEAEs will be summarized according to intensity (CTCAE, v5) for hematologic toxicity, and drug relationship, as well as categorized by system organ class and preferred term. Summaries, listings, datasets, or subject narratives may be provided, as appropriate, for those subjects who die, who discontinue treatment due to an AE, or who experience a severe AE or a SAE. |
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT07208981
GET https://conductscience.org/api/trials/v1/NCT07208981/registered