Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04662255 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)

Study acronym: BRUIN-MCL-321
StatusActive, Not Recruiting
PhasePhase 3
Started2021-04-08
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 9 months later Jan 2027 → Nov 2027
See other at-risk trials from Loxo Oncology, Inc.

Amendment history

2026-09-24
Primary completion pushed: 2027-01 → 2027-11
Completion pushed: 2028-04 → 2030-06
2026-05-13
Study Status v34
Re-verified, no change to tracked fields
2025-05-27
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v33
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 189 of 189 sites
2025-05-20
Study Status, Contacts/Locations v32
Study sites206→189
2025-04-18
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v31
Trial statusActive, Not Recruiting→Recruiting
Study sites227→206
Show 30 earlier versions
2025-04-07
Study Status v30
Primary completion date2025-12→2027-01
Completion date2026-07→2028-04
2025-04-03
Study Identification, Study Status v29
Re-verified, no change to tracked fields
2024-05-10
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v28
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-04→2025-12
Completion date2025-04→2026-07
Study sitesdetails revised at 227 of 227 sites
2024-01-24
Study Status, Contacts/Locations v27
Study sites223→227
2023-10-03
Study Status, Contacts/Locations v26
Study sites217→223
2023-08-28
Study Status, Contacts/Locations v25
Study sites209→217
2023-07-07
Study Status, Contacts/Locations v24
Study sites198→209
2023-05-30
Study Status, Contacts/Locations v23
Study sites195→198
2023-04-24
Study Status, Contacts/Locations v22
Study sites183→195
2023-03-03
Study Status, Contacts/Locations v21
Study sites183 entries, revised
Ospedale Didi Circolo Ee Fondazione Macchi Varese National Cheng- Kung Uni.University Hosp.Hospital
2023-02-15
Study Status v20
Re-verified, no change to tracked fields
2023-01-23
Study Status, Eligibility v19
Eligibility criteria+76 characters
[...] f screening. AST and ALT ≤ 3.0 x upper limit of normal (ULN). Total bilirubin ≤ 1.5 x ULN. Creatinine clearance of ≥ 30 m [...] Gs Known HIV infection or active HBV, HCV, or CMV infections. (Certain participants with controlled HBV infections may still be eligible) Clinically significant active malabsorption syndrome or othe [...]
2023-01-10
Study Status v18
Re-verified, no change to tracked fields
2022-12-15
Study Status, Contacts/Locations v17
Study sites161→183
2022-11-11
Study Status, Contacts/Locations v16
Study sites160→161
2022-10-13
Study Status, Contacts/Locations v15
Study sitesdetails revised at 1 of 160 sites
2022-08-29
Study Status, Contacts/Locations v14
Study sites159→160
2022-08-15
Study Status, Sponsor/Collaborators v13
Collaborators+21 characters
Eli Lilly and Company
2022-06-27
Study Status v12
Re-verified, no change to tracked fields
2022-06-01
Study Status, Contacts/Locations v11
Study sites159 entries, revised
Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen Kaohsiung Medical University Chung-Ho Memorial Hospital
2022-04-27
Study Status, Contacts/Locations v10
Study sites160→159
2022-04-21
Study Status, Contacts/Locations v9
Primary completion date2024-07-01→2025-04
Completion date2024-07-01→2025-04
Study sites148→160
2022-03-04
Study Identification, Study Status, Contacts/Locations v8
Primary completion date2024-08→2024-07-01
Completion date2025-02→2024-07-01
Start date2021-03-05→2021-04-08
Study sites131→148
2022-02-11
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v7
Study sites84→131
InterventionsAcalabrutinib (Drug), Ibrutinib (Drug), LOXO-305 (Drug), Zanubrutinib (Drug)→Acalabrutinib (Drug), Ibrutinib (Drug), Pirtobrutinib (Drug), Zanubrutinib (Drug)
Eligibility criteria+94 characters
[...] condition likely to affect gastrointestinal (GI) absorption CurrentOngoing chronic treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers and/orwhich strongcannot Pbe stopped within 3-gp5 inhibitorshalf lives of the CYP3A inhibitor therapy prior to start of study drug treatment. Patients requiring therapeutic anticoagulation with warfar [...]
Secondary endpoints7 entries, revised
To compare Overall Response Rate (ORR) of LOXO-305pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent B [...] B) treatment arms To compare Duration of Response (DOR) of LOXO-305pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent B [...] erapy (Arm B) treatment arms To compare Overall Survival of LOXO-305pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
Primary endpoints1 entry, revised
To compare progression-free survival (PFS) of LOXO-305pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent B [...]
Study description+5 characters
This is a Phase 3 global, randomized, open-label study comparing LOXO-305pirtobrutinib (Arm A) to investigator's choice of ibrutinib, acalabrutini [...]
2021-11-11
Study Status, Contacts/Locations v6
Study sites50→84
2021-09-17
Study Status, Contacts/Locations v5
Study sites45→50
2021-08-23
Study Status, Contacts/Locations v4
Study sites59→45
2021-06-07
Study Status, Contacts/Locations v3
Study sites51→59
2021-04-30
Study Identification, Study Status, Contacts/Locations v2
Study sites8→51
2021-03-19
Not Yet Recruiting→Recruiting Study Status, Conditions, Arms and Interventions, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-01→confirmed 2021-03-05
Study sites0→8
2020-12-04
Original filing
This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress.
Trial Details
NCT Number NCT04662255
Lead Sponsor Loxo Oncology, Inc.
Collaborators: Eli Lilly and Company
Conditions Lymphoma, Mantle-Cell
Enrollment 500 participants
Start Date 2021-04-08
Primary Completion 2027-11 (estimated)
Study Completion 2030-06 (estimated)
Updated on ClinicalTrials.gov 2026-09-23