Orelabrutinib Combined With Zuberitamab in the Initial Treatment of MZL
ZOOM
Sponsor study identifier
interventional
33
1 country
2
Study Start
November 13, 2024
Actual (reported)Primary Completion
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This is a multi-center, prospective cohort study. The main purpose of study is to evaluate the efficacy and safety of Orelabrutinib combined with Zuberitamab in the initial treatment of MZL Main efficacy indicators Complete response rate (CR) at the end of combination therapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 13, 2024
Actual (reported)November 13, 2024
Actual (reported)May 22, 2025
Actual (reported)December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
1Y CRR
Complete response rate (CR) at the end of combination therapy Efficacy evaluation was performed every 3 cycles (12 weeks) during the treatment period, every 3 months during the maintenance treatment period, and every 3-6 months during the observation and follow-up period, using Lugano 2014 efficacy evaluation criteria. MRD tests are performed every 6 cycles within 2 years of starting the drug.For the main efficacy indicators, complete response rate (CR) and 95%CI were calculated.
2 years
uMRD
2 years
ORR
2 years
PFSR in 24m
2 years
OSR in 24m
2 years
Orelabrutinib combined with Zuberitamab for 6 cycles induction therapy, after that patients were treated with Orelabrutinib combined with Zuberitamab (administered every 2 cycles) for 6 cycles or had disease progression or toxicity intolerance.
Orelabrutinib 150mg, po, gd, D1-D28, every 28 days, cycle 1-12; Zuberitamab: intravenously administered on day 1 of the cycle at a dose of 375mg/m2 every 28 days, once every cycle for cycles 1-6 and once every 2 cycles for cycles 7-12.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 515800, China
First Submitted
November 13, 2024
First Posted
May 22, 2025
Study Start
November 13, 2024
Actual (reported)Primary Completion
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 22, 2025
Record last verified: 2025-05
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Source: ClinicalTrials.gov.
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