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Acalabrutinib With or Without Obinutuzumab in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

StatusRecruiting
PhasePhase 2
Started2018-09-10
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 19 months later Mar 15, 2027 → Nov 11, 2028
See other at-risk trials from Mayo Clinic

Amendment history

2026-10-02
Primary completion pushed: 2027-03-15 → 2028-11-11
Completion pushed: 2030-10-16 → 2036-11-11
2026-06-23
Study Status, Contacts/Locations v22
Study sitesdetails revised at 1 of 3 sites
2026-02-05
Study Status v21
Primary completion date2030-10-16→2027-03-15
2026-01-29
Study Status, Oversight v20
Re-verified, no change to tracked fields
2025-08-28
Study Status, Oversight, Outcome Measures v19
Completion date2031-10-16→2030-10-16
Secondary endpointsdetails revised at 7 of 7 entries
Primary endpoints2 entries, revised
Time to first therapy (TFT) in patients (Arm C)
Show 18 earlier versions
2025-02-24
Study Identification, Study Status, Oversight, Contacts/Locations v18
Primary completion date2030-03-15→2030-10-16
Completion date2031-03-15→2031-10-16
Study sitescontacts updated at 3 of 3 sites
Study titlerevised
Acalabrutinib withWith or Without Obinutuzumab in Treating Patients withWith Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
2025-02-21
Study Status v17
Primary completion date2025-03-15→2030-03-15
Completion date2026-03-15→2031-03-15
2024-11-06
Study Identification, Study Status, Oversight, Contacts/Locations v16
Study sitescontacts updated at 3 of 3 sites
Study titlerevised
Acalabrutinib Withwith or Without Obinutuzumab in Treating Patients Withwith Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
2023-11-27
Study Identification, Study Status, Contacts/Locations, References v15
2023-05-17
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v14
Eligibility criteria-124 characters
Inclusion Criteria: Age >= 18 years Diagnosis of: Biopsy-proven small lymphocytic lymphoma (SLL) [...] ile on study Requires treatment with a strong CYP3A inducer Requires treatment with proton-pump inhibitors (e.g. omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole) Presence of a gastrointestinal ulcer diagnosed by endoscopy [...]
Secondary endpointsdetails revised at 7 of 7 entries
Study description+1 characters
[...] reatment, patients are followed up every 6 months for up to 510 years.
Study sitescontacts updated at 1 of 3 sites
Collaborators-31 characters
National Cancer Institute (NCI)
2023-01-05
2 amendments v12-v13
2 re-verifications since 2022-09-08, no change to tracked fields
2021-08-19
Study Status, Contacts/Locations v11
Study sitescontacts updated at 1 of 3 sites
2021-06-07
2 amendments v9-v10
2 re-verifications since 2021-05-21, no change to tracked fields
2020-12-21
Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v8
Completion date2025-03-15→2026-03-15
Eligibility criteria+320 characters
[...] or t(11;14)(IgH/CCND1) Patients must be previously untreated (see Note) Note: Prior chemotherapy or monoclonal antibody based thera [...] for treatment of CLL or SLL will be considered prior therapy. Nutraceutical; nutraceutical treatments with no established benefit in CLL (such as epig [...] plemental vitamins) will not be considered "prior treatment". Prior; prior corticosteroid therapy for an indication other than CLL/SLL will not be considered "prior treatment". All patients will undergo testing for prognostic factors according to the CLL-IPI (testing obtained ≤120=< 730 days prior to registration), No [...] [...]
Secondary endpoints7 entries, revised
Incidence of adverse events rates according to Common Terminology Criteria for Adverse Events version 4.0 (Arms A and B)
Study description+50 characters
[...] ents with low and intermediate risk by CLL-IPI. EXPLORATORY OBJECTIVESOBJECTIVE: I. To evaluate the quality of life using Functional Assess [...] ates will be studied for hematopoietic function in two ways: VIa. estimationEstimation of colony forming capacity by purified hematopoietic stem cells (HSCs). VIb. and evaluationEvaluation of the levels of HSCs and their differentiated progeny (i.e [...] A) metabolism, NF-kappaB pathway, cell cycle and apoptosis. IX. Screen 2 genes previously associated with resistance to BTK inhibitors (BTK and PLCG2). OUTLINE: ParticipantsPatients with high or very high risk CLL [...] [...]
Study sites3 entries, revised
Mayo Clinic Hospitalin Arizona Mayo Clinic in Rochester
Study title-4 characters
Acalabrutinib With or Without Obinutuzumab in Treating ParticipantsPatients With Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
2020-11-02
Study Status, Contacts/Locations v7
Study sitescontacts updated at 3 of 3 sites
2019-10-07
Study Status v6
Re-verified, no change to tracked fields
2018-09-26
Study Status, Contacts/Locations v5
Study sitesdetails revised at 3 of 3 sites
2018-09-10
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2018-08-20→confirmed 2018-09-10
Study sitesdetails revised at 3 of 3 sites
2018-08-13
Study Status v3
Start date2018-07-20→2018-08-20
2018-06-05
Study Status v2
Start date2018-05-20→2018-07-20
2018-05-22
Study Status, Eligibility v1
Eligibility criteria+28 characters
[...] or t(11;14)(IgH/CCND1) Patients must be previously untreated (see Note) Note: Prior chemotherapy or monoclonal antibody based thera [...] for treatment of CLL or SLL will be considered prior therapy; nutraceutical. Nutraceutical treatments with no established benefit in CLL (such as epig [...] treatments or supplemental vitamins) will not be considered ?"prior treatment?; prior". Prior corticosteroid therapy for an indication other than CLL/SLL will not be considered ?"prior treatment?". All patients will undergo testing for prognostic factors according to the CLL-IPI (testing obtained ? ≤120 days prior to [...] [...]
2018-05-03
Original filing
This phase II trials studies how well acalabrutinib with or without obinutuzumab works in treating patients with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving acalabrutinib with or without obinutuzumab will work better in treating patients with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma.
Trial Details
NCT Number NCT03516617
Lead Sponsor Mayo Clinic
Conditions Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Enrollment 120 participants
Start Date 2018-09-10
Primary Completion 2028-11-11 (estimated)
Study Completion 2036-11-11 (estimated)
Updated on ClinicalTrials.gov 2026-10-01