Early Intervention With Acalabrutinib in Patients With High Risk CLL
NCT04660045 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2022-04-05
Summary
This study evaluates the effectiveness of acalabrutinib treatment in patients with chronic lymphocytic leukemia (CLL) deemed at high risk for Richter's Transformation (RT). This is a single arm study. Enrolled patients will initiate therapy with acalabrutinib and will dose continuously. While on study, subjects will be monitored monthly for the first 3 months, then every three months thereafter until disease progression, discontinuation due to toxicity, death, or study completion.
Conditions
- Chronic Lymphocytic Leukemia
- CLL/SLL
Interventions
- DRUG
-
Acalabrutinib, oral, 100 mg BID, continuous
Sponsors & Collaborators
- collaborator INDUSTRY
-
Weill Medical College of Cornell University
lead OTHER
Principal Investigators
-
John N Allan, M.D. · Weill Medical College of Cornell University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-31
- Primary Completion
- 2026-01-31
- Completion
- 2026-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Acalabrutinib in CLL and MCL Patients Subjected to Allogeneic Hematopoietic Stem Cell Transplantation (alloSCT)
NCT04716075 ·Status: COMPLETED ·Phase: PHASE2
-
Acalabrutinib Safety Study in Untreated and Relapsed or Refractory Chronic Lymphocytic Leukemia Patients
NCT04008706 ·Status: COMPLETED ·Phase: PHASE3
-
Acalabrutinib for the Treatment of Relapsed or Refractory Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia
NCT04657094 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Copanlisib Plus Ibrutinib or Acalabrutinib in R/R CLL
NCT04685915 ·Status: WITHDRAWN ·Phase: PHASE2
-
Acalabrutinib for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
NCT06757647 ·Status: RECRUITING ·Phase: PHASE2
-
Ibrutinib as Early Therapy in Chronic Lymphocytic Leukemia (CLL)
NCT03207555 ·Status: COMPLETED ·Phase: PHASE2
-
Acalabrutinib Monotherapy vs Investigator's Choice of Treatment in Patients With CL Leukaemia and Heart Failure
NCT06651970 ·Status: RECRUITING ·Phase: PHASE4
-
Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL
NCT04624633 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Treatment With Acalabrutinib Post Blood or Marrow Transplantation in Subjects With Mantle Cell Lymphoma
NCT04402138 ·Status: COMPLETED ·Phase: PHASE2
-
Decitabine in Treating Patients With Previously Untreated Acute Myeloid Leukemia
NCT00492401 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)
NCT02477696 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Acalabrutinib With or Without Obinutuzumab in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT03516617 ·Status: RECRUITING ·Phase: PHASE2
-
Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL/SLL
NCT07014917 ·Status: RECRUITING ·Phase: PHASE2
-
ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (BTK) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia
NCT02029443 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Observ Prosp Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Belarus
NCT07288515 ·Status: RECRUITING
-
Efficacy of Acalabrutinib in Very Old or Frail Patients With Treatment-naïve or Relapsed/Refractory CLL
NCT04883749 ·Status: COMPLETED ·Phase: PHASE2
-
Acalabrutinib and Obinutuzumab for the Treatment of Chronic Lymphocytic Leukemia
NCT04505254 ·Status: RECRUITING ·Phase: PHASE2
-
Observational Study of Acalabrutinib in Patients With Chronic Lymphocytic Leukaemia in the United Kingdom
NCT05557695 ·Status: RECRUITING
-
Lenalidomide Following Fludarabine/Rituximab (FR) in Untreated Chronic Lymphocytic Leukemia (CLL)
NCT00860457 ·Status: COMPLETED ·Phase: PHASE2
-
Lenalidomide With or Without Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
NCT00096044 ·Status: COMPLETED ·Phase: PHASE2
-
Acalabrutinib and Venetoclax Treatment of Newly Diagnosed Patients With CLL at High Risk of Infection or Early Treatment
NCT03868722 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Cardiotoxicities in Patients Receiving BTKi
NCT05521178 ·Status: WITHDRAWN
-
A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT05057494 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Lenalidomide and AT-101 in Treating Patients With Relapsed B-Cell Chronic Lymphocytic Leukemia
NCT01003769 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Phase I Study of Lenalidomide, Rituximab and Ibrutinib in Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)
NCT02200848 ·Status: TERMINATED ·Phase: PHASE1