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Phase II Study of Chlorambucil and Subcutaneous Rituximab in Patients With Extranodal MALT Lymphoma

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. 7 versions Re-verified since Jan 20, 2021, no change to tracked fieldsv9-v15
  2. Study sites: 39 to 38v8
  3. Site details revised at 1 of 39 sitesv7
  4. Re-verified, no change to tracked fieldsv6
  5. Trial status: Recruiting to Active, Not Recruitingv5 Show 4 more changesShow less
    • Primary completion date changed from estimate of Jul 2017 to Mar 2016
    • Study completion date: Dec 2025 to Sep 2028
    • Site details revised at 39 of 39 sites
    • Study title shortened, about 4 words
Show 3 earlier versionsHide 3 earlier versions
  1. Re-verified, no change to tracked fieldsv4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 39
    v3
  3. Start date: Mar 2013 to Dec 2013v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Single arm phase II study of Chlorambucil in combination with subcutaneous Rituximab followed by maintenance therapy with subcutaneous Rituximab in patients with histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extranodal site, either de novo, or relapsed following local therapy (including surgery, radiotherapy and antibiotics for H. pylori-positive gastric lymphoma).
Trial Details
NCT Number NCT01808599
Lead Sponsor International Extranodal Lymphoma Study Group (IELSG)
Conditions
(from sponsor)		 MALT Lymphoma
Related terms Lymphoma, B-Cell, Marginal Zone
Enrollment 112 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov