Safety of PCI-32765 in Chronic Lymphocytic Leukemia
NCT01105247 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 133
Last updated 2014-03-31
Summary
The purpose of this study is to establish the safety and efficacy of orally administered PCI-32765 in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma.
Conditions
- B-cell Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
Interventions
- DRUG
-
PCI-32765
420 mg daily or 840 mg daily
Sponsors & Collaborators
-
Pharmacyclics LLC.
lead INDUSTRY
Principal Investigators
-
Danelle James, M.D., M.A.S · Pharmacyclics LLC.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-05-31
- Primary Completion
- 2012-12-31
- Completion
- 2013-02-28
Countries
- United States
Study Locations
More Related Trials
-
Safety and Efficacy of PCI-32765 in Participants With Relapsed/Refractory Mantle Cell Lymphoma (MCL)
NCT01236391 ·Status: COMPLETED ·Phase: PHASE2
-
PCI-32765 (Ibrutinib) in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-cell Prolymphocytic Leukemia
NCT01589302 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
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
-
Pharmacokinetics (PK), Pharmacodynamics (PD), Safety, Tolerability of Multiple Dose Regimens of MT-3724 for the Treatment of Patients With Relapsed Chronic B-cell Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT02556346 ·Status: WITHDRAWN ·Phase: PHASE1
-
A Study to Evaluate the Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in Patients With Recurrent Mature B-Cell Neoplasms
NCT01704963 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of PCI-32765 (Ibrutinib) Versus Rituximab in Relapsed or Refractory Chronic Leukemia/Lymphoma
NCT01973387 ·Status: COMPLETED ·Phase: PHASE3
-
PCI-32765 for Special Cases of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT01500733 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
NCT01578707 ·Status: COMPLETED ·Phase: PHASE3
-
Trial of PCI-32765 (BTK Inhibitor) in Combination With Carfilzomib in Relapse/Refractory Mantle Cell Lymphoma
NCT02269085 ·Status: TERMINATED ·Phase: PHASE1
-
ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (APEX-03)
NCT06378138 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Troxacitabine in Treating Patients With Chronic Myelogenous Leukemia
NCT00012259 ·Status: COMPLETED ·Phase: PHASE2
-
Ibrutinib (PCI-32765) in Waldenstrom's Macroglobulinemia
NCT01614821 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 2 Study of Duvelisib in Previously Treated Patients With Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma
NCT03370185 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Long-term Extension Study of PCI-32765 (Ibrutinib)
NCT01804686 ·Status: RECRUITING ·Phase: PHASE3
-
Liposome-encapsulated Daunorubicin-Cytarabine, Fludarabine Phosphate, Cytarabine, and Filgrastim in Treating Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT02642965 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia
NCT03654768 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT01724346 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Study of PD-616 Plus Cytarabine to Treat Acute Myelogenous Leukemia or Myelodysplastic Syndrome
NCT01795924 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Ibrutinib in Treating Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
NCT02129062 ·Status: TERMINATED ·Phase: PHASE2
-
Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.
NCT01844765 ·Status: COMPLETED ·Phase: PHASE2
-
Ofatumumab and Dinaciclib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-Cell Prolymphocytic Leukemia
NCT01515176 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Oral Clofarabine for Acute Myeloid Leukemia
NCT00727766 ·Status: COMPLETED ·Phase: PHASE1
-
Ibrutinib in Preventing Acute Leukemia in Patients After Reduced-Intensity Conditioning and Stem Cell Transplant
NCT03267186 ·Status: COMPLETED ·Phase: PHASE2
-
Ipilimumab in Treating Patients With Relapsed or Refractory High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia
NCT01757639 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Combination With Low Intensity Chemotherapy in Older Patients With Newly Diagnosed B-cell Acute Lymphoblastic Leukemia
NCT07153796 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2