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A Study of Ibrutinib With Rituximab in People With Untreated Marginal Zone Lymphoma

StatusActive, Not Recruiting
PhasePhase 3
Started2019-12-23
View on ClinicalTrials.gov ↗

Amendment history

2026-07-22
2 amendments v21-v22
2 re-verifications since 2025-07-22, no change to tracked fields
2024-07-22
Study Status v20
Primary completion date2024-06-30→2027-03-18
2024-03-27
Study Status, Contacts/Locations v19
Study sites13→10
2023-12-27
Study Status, Contacts/Locations v18
Study sites14→13
2023-08-02
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v17
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 138→confirmed 23
Study sitesdetails revised at 14 of 14 sites
Show 16 earlier versions
2023-06-28
Study Status, Contacts/Locations v16
Study sitesdetails revised at 1 of 14 sites
2023-05-31
Study Status, Contacts/Locations v15
Study sites13→14
2023-03-15
Study Status, Eligibility v14
Eligibility criteria+2 characters
[...] or sterilized partner) during the period of therapy and for 3012 daysmonths (females) and 90 days (males) after the last dose of study [...]
2022-11-29
Study Status v13
Re-verified, no change to tracked fields
2022-11-28
Study Status, Contacts/Locations v12
Study sitesdetails revised at 1 of 13 sites
2022-03-09
Study Status, Contacts/Locations v11
Study sitesdetails revised at 1 of 13 sites
2022-03-07
Study Status v10
Re-verified, no change to tracked fields
2021-11-19
Study Status, Contacts/Locations v9
Study sites12→13
2021-09-21
Study Status, Eligibility v8
Eligibility criteria+190 characters
[...] computed tomography (CT) scan (>1.5 cm in longest dimension) unless bone marrow disease only including those with hemolytic anemia. Lesions in anatomical locations (such as extremities or so [...] Rate GFR [Cockcroft-Gault]) <30 mL/min Hemoglobin <8.0 g/dL unless secondary to hemolysis or documented bone marrow involvement Bilirubin >1.5 x ULN (unless bilirubin rise is due to Gilbe [...] -hepatic origin) PT/INR >1.5 x ULN and PTT (aPTT) >1.5 x ULN unless factor XI deficiency or lupus anticoagulant. Unable to swallow capsules or disease significantly affecti [...]
2021-08-13
Study Status, Contacts/Locations v7
Study sitesdetails revised at 1 of 12 sites
2021-06-10
2 amendments v5-v6
2 re-verifications since 2021-03-23, no change to tracked fields
2020-12-07
Study Status, Eligibility, Contacts/Locations v4
Eligibility criteria+27 characters
[...] hey had prior splenectomy or other local surgical treatment or local radiation therapy without systemic therapy and now require their first ever sy [...]
Study sitescontacts updated at 7 of 12 sites
2020-11-17
Study Status, Eligibility v3
Eligibility criteria+206 characters
[...] t central nervous system lymphoma or leptomeningeal disease Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible History of other malignancies except adequately treated non- [...]
2020-08-20
Study Status, Arms and Interventions, Eligibility, Contacts/Locations v2
Study sites7→12
Eligibility criteria+163 characters
[...] e (LDH), rapidly worsening disease, or frequent B-symptoms, both a pre-treatment tumor biopsy isand bone marrow biopsy are required to rule out large cell transformation. For all subjects, results of both the tumor biopsy and bone marrow biopsy must be known prior to enrollment and randomization. Exclusion Criteria: Medically apparent central nervous syste [...]
2020-02-17
Study Status v1
Primary completion date2021-12→2024-06-30
Completion date2021-12→2027-03-18
2019-12-23
Original filing
The purpose of this study is to see if the combination of rituximab and ibrutinib can help people with marginal zone lymphoma who have not received treatment in the past. The study will also compare the combination of rituximab and ibrutinib with the combination of rituximab and placebo to see which combination works better.
Trial Details
NCT Number NCT04212013
Lead Sponsor Memorial Sloan Kettering Cancer Center
Collaborators: Pharmacyclics LLC.
Conditions Marginal Zone Lymphoma
Enrollment 23 participants
Start Date 2019-12-23
Primary Completion 2027-03-18 (estimated)
Study Completion 2027-03-18 (estimated)
Updated on ClinicalTrials.gov 2026-07-23