Identification of Biomarkers That Are Predictive of Early Ibrutinib Treatment Failure in High Risk TP53 Mutated Chronic Lymphocytic Leukemia
NCT02827617 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 56
Last updated 2025-11-18
Summary
The general aim of the project is the identification of dynamic molecular markers that can help the early and real time prediction of sustained benefit or no benefit from ibrutinib treatment in CLL harboring TP53 mutations. Specific aims of the project include: 1) Assess whether clearance of TP53 mutated clones translates into a predictive biomarker of long term benefit from ibrutinib treatment in CLL. 2) Assess whether plasma cell free DNA represents a sensitive tool that can early and dynamically inform on the development of ibrutinib resistant mutations in CLL.
Conditions
Interventions
- DRUG
-
Treatment with ibrutinib 420 mg quaque die in the clinical practice
Sponsors & Collaborators
-
Oncology Institute of Southern Switzerland
lead OTHER
Principal Investigators
-
Davide Rossi, MD, PhD · Oncology Institute of Southern Switzerland
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-06-01
- Primary Completion
- 2021-08-31
- Completion
- 2024-05-16
Countries
- Italy
- Switzerland
Study Locations
More Related Trials
-
A Multi-Center Study of Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Patients With Treatment naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
NCT02264574 ·Status: COMPLETED ·Phase: PHASE3
-
Fixed-duration Therapy With Ibrutinib and Obinutuzumab (GA-101) in Treatment-naïve Patients With CLL
NCT04908228 ·Status: RECRUITING ·Phase: PHASE2
-
Interaction Study of Ibrutinib and Cytochrome P450 (CYP) 3A Inhibitors in Participants With B-cell Malignancy
NCT02381080 ·Status: COMPLETED ·Phase: PHASE1
-
Prospective Collection of Biological Data of Prognostic Relevance in Patients With B-Cell Chronic Lymphocytic Leukemia
NCT00917540 ·Status: UNKNOWN
-
A Prognostic Tool for Early Stage CLL
NCT03436524 ·Status: COMPLETED
-
Study to Evaluate the Safety and Efficacy of the Combination of Tirabrutinib and Idelalisib With and Without Obinutuzumab in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
NCT02968563 ·Status: COMPLETED ·Phase: PHASE2
-
Tolerance and Resistance to Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL
NCT03502876 ·Status: COMPLETED
-
S0106A, Biomarkers in Samples From Patients With Newly Diagnosed Acute Myeloid Leukemia Treated With Cytarabine-Based Chemotherapy
NCT01360125 ·Status: COMPLETED
-
Open-label Phase 3 BTK Inhibitor Ibrutinib vs Chlorambucil Patients 65 Years or Older With Treatment-naive CLL or SLL
NCT01722487 ·Status: COMPLETED ·Phase: PHASE3
-
A Prospective Multicenter Phase 2 Study of FCR/BR Alternating With Ibrutinib in Treatment-naive Patients With CLL
NCT03980002 ·Status: RECRUITING ·Phase: PHASE2
-
S9031-S9333-S0112-S0301-A Biomarkers Associated With Response to Cytarabine in Samples From Older Patients With Acute Myeloid Leukemia
NCT01338974 ·Status: COMPLETED
-
Efficacy Study of Inecalcitol With Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy
NCT02802267 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study of CPI-613 for Patients With Relapsed or Refractory Burkitt Lymphoma/Leukemia or High-Grade B-Cell Lymphoma With High-Risk Translocations
NCT03793140 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Ibrutinib in Combination With GA101 (Obinutuzumab) in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Patients.
NCT02315768 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT02518555 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Investigate the Efficacy and Safety of MS-553 in CLL/SLL
NCT05272813 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A Phase II Study of Ibrutinib Plus FCR in Previously Untreated, Younger Patients With Chronic Lymphocytic Leukemia
NCT02251548 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL
NCT02268851 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Safety and Preliminary Efficacy of Ibrutinib and Pembrolizumab in Patients With Chronic Lymphocytic Leukemia (CLL) or Mantle Cell Lymphoma (MCL)
NCT03153202 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia
NCT01138306 ·Status: COMPLETED
-
Blinatumomab Versus Standard of Care Chemotherapy in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)
NCT02013167 ·Status: TERMINATED ·Phase: PHASE3
-
Irinotecan and Cytarabine in Treating Patients With Refractory or Recurrent Acute Myeloid Leukemia or Chronic Myelogenous Leukemia
NCT00053144 ·Status: COMPLETED ·Phase: PHASE1
-
Ibrutinib, Fludarabine, and Pembrolizumab in High-Risk or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
NCT03204188 ·Status: COMPLETED ·Phase: PHASE2
-
Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)
NCT02301156 ·Status: COMPLETED ·Phase: PHASE3
-
ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (APEX-03)
NCT06378138 ·Status: RECRUITING ·Phase: PHASE2/PHASE3