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RCT on Intralesional Rituximab Injection Versus ISRT in Ocular Adnexal MALT Lymphoma

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Study sites: 2 to 1
    • Start date: Jan 11, 2024 to Dec 20, 2023
    v6
  2. Primary and study completion dates: Dec 31, 2027 to Dec 31, 2029v5
  3. Primary endpoint revised
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 4 of 4 entries
    v4
  4. Eligibility criteria shortened, about 36 wordsv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Start date changed from estimate of Dec 31, 2023 to Jan 11, 2024
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This project proposes to establish a prospective, multicenter, randomized, controlled clinical study to compare the safety and efficacy of Intralesional Rituximab Injection versus Involved Site Radiation Therapy for the treatment of primary ocular adnexal MALT lymphoma. The aim is to provide high-level clinical evidence for the treatment of ocular adnexal MALT lymphoma and to offer patients treatment options that have fewer complications and comparable therapeutic effects.
Trial Details
NCT Number NCT06190301
Lead Sponsor Zhongshan Ophthalmic Center, Sun Yat-sen University
Conditions
(from sponsor)		 Primary Ocular Adnexal MALT Lymphoma
Enrollment 108 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov