Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05976763 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma

StatusRecruiting
PhasePhase 3
Started2023-10-20
View on ClinicalTrials.gov ↗

Amendment history

2026-09-01
Study Status, Contacts/Locations v24
Study sitesdetails revised at 3 of 238 sites
2026-08-04
Study Status, Contacts/Locations v23
Study sites237→238
2026-07-15
Study Status, Oversight, Study Description, Eligibility v22
Eligibility criteria-17 characters
[...] n D1 (BCL1) expression by immunohistochemical stains and/or evidence of CCND1 rearrangement or t(11;14) by cytogenetics or fluorescence in situ hybridization (FISHq13;q32) as confirmed by the enrolling center (such as by fluorescence in situ hybridization [FISH], polymerase chain reaction [PCR]/sequencing, karyotype). Patients with cyclin D1 and/or t(11;14) negative mantle cell lymphoma with an expression profile suggesting a diagnosis of mantle cell lymphoma [MCL] such as SOX11 expression are also eligible Any stage allowed (stage I-IV) PresencePatient ofmust have at least one objective measu [...] [...]
Study description+340 characters
[...] E: I. To compare health-related quality of life (QOL) at 12 cyclesmonths post-randomization as assessed by the Functional Assessment [...] and cognitive PRO as assessed by Elderly Functional Index (EFLIELFI) and Neurology (Neuro) QOL in Arm A versus Arm B. II. To co [...] NDUCTION THERAPY: Patients receive zanubrutinib orally (PO) twice daily (BID) on days 1-28 of each cycle and rituximab intravenously (IV) on studyday 1 of each cycle. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. . Patients undergo bone marrow biopsy and fluciclovine F18 [...] [...]
2026-07-01
Study Status, Contacts/Locations v21
Study sitesdetails revised at 8 of 237 sites
2026-06-01
Study Status, Contacts/Locations v20
Study sites236→237
2026-05-07
Study Status, Contacts/Locations v19
Trial sites expanded: 233 → 236 locations
2026-04-06
Study Status, Contacts/Locations v18
Study sites231→233
2026-03-02
Study Status, Contacts/Locations v17
Study sites230→231
2026-02-03
Study Status, Contacts/Locations v16
Study sites228→230
2025-12-08
Study Status, Contacts/Locations v15
Study sites227→228
2025-11-04
Study Status, Contacts/Locations v14
Study sitesdetails revised at 2 of 227 sites
2025-10-07
Study Status, Contacts/Locations v13
Study sites218→227
2025-09-04
Study Status, Contacts/Locations v12
Study sites213→218
2025-06-24
Study Status, Contacts/Locations v11
Study sites209→213
2025-03-28
Study Identification, Study Status, Contacts/Locations v10
Study sites204→209
Study titlerevised
Testing Continuous Versus Intermittent Treatment withWith the Study Drug Zanubrutinib for Older Patients withWith Previously Untreated Mantle Cell Lymphoma
2025-01-13
Study Identification, Study Status, Contacts/Locations v9
Start date2023-09-08→2023-10-20
Study sitescontacts updated at 203 of 204 sites
Study titlerevised
Testing Continuous Versus Intermittent Treatment Withwith the Study Drug Zanubrutinib for Older Patients Withwith Previously Untreated Mantle Cell Lymphoma
2024-12-24
Study Status, Contacts/Locations v8
Study sites178→204
2024-08-01
Study Status, Contacts/Locations v7
Study sites155→178
2024-05-22
Study Status, Contacts/Locations v6
Study sites138→155
2024-04-08
Study Status, Contacts/Locations v5
Study sites104→138
2024-02-19
Study Status, Contacts/Locations v4
Study sites62→104
2023-11-30
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Study sites0→62
2023-09-13
Study Identification, Study Status v2
Re-verified, no change to tracked fields
2023-08-30
Study Status v1
Start date2023-08-08→2023-09-08
2023-07-26
Original filing
This phase III trial tests whether continuous or intermittent zanubrutinib after achieving a complete remission (CR) with rituximab works in older adult patients with mantle cell lymphoma (MCL) who have not received treatment in the past (previously untreated). Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Zanubrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. When zanubrutinib is used in MCL, the current standard of care is to continue administering the drug indefinitely until disease progression. This continuous treatment comes with clinical as well as financial toxicity, which could be especially detrimental in older patients. For patients who achieve a CR after initial zanubrutinib plus rituximab therapy, it may be safe and equally effective to stop treatment and restart zanubrutinib upon disease progression rather than continuing indefinitely in previously untreated older adult patients with MCL.
Trial Details
NCT Number NCT05976763
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Mantle Cell Lymphoma
Enrollment 421 participants
Start Date 2023-10-20
Primary Completion 2038-08-31 (estimated)
Study Completion 2038-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-02