At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 28 enrolled
Drug / intervention
Ibrutinib +2 moredrug
Likely dose
Not stated in record
Key inclusion· 7
- ✓Relapsed or refractory classical HL with prior autologous stem cell transplant ≥12 weeks before first dose of ibrutinib
- ✓Relapsed or refractory classical HL with prior allogeneic stem cell transplant ≥6 months before first dose of ibrutinib
- ✓Relapsed or refractory HL failing ≥2 prior therapy lines and ineligible for autologous stem cell transplant due to inability to achieve CR/PR, age, comorbidities, or inability to collect stem cells
- ✓Prior treatment with ≥2 lines of therapy for HL including brentuximab vedotin, or ≥2 prior regimens if brentuximab vedotin ineligible
Key exclusion· 11
- ✕Prior BTK inhibitor therapy
- ✕Known cerebral/meningeal disease
- ✕Nodular lymphocyte predominant Hodgkin lymphoma subtype
- ✕Allogeneic stem cell transplant within 6 months of enrollment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Multicenter Single Arm Study to Evaluate the Efficacy and Safety of Single Agent Bruton's Tyrosine Kinase Inhibitor, Ibrutinib, in Patients With Relapsed Refractory Classical Hodgkin's Lymphoma
In Brief
A Phase 2 clinical trial evaluating Ibrutinib, Laboratory Biomarker Analysis, and 1 other intervention for Classical Hodgkin Lymphoma and 2 related conditions. Completed, enrolled 28 participants across 4 sites.
Detailed Summary
This phase II trial evaluates how effective 560 mg of ibrutinib taken by mouth daily is in the treatment of classical Hodgkin lymphoma which recurs or does not respond to initial treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth, by altering the environment around the tumor or by affecting the immune system.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartJun 2016
First PostedJul 2016
Primary CompletionMay 2023
Study CompletionJan 2025
TodayJul 2026
First PostedJul 6, 2016
Enrollment StartJun 1, 2016
Primary CompletionMay 12, 2023
Study CompletionJan 8, 2025
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 10.0 years ago
Interventions
Ibrutinibdrug
Given PO
Laboratory Biomarker Analysisother
Correlative studies
Pharmacological Studyother
Correlative studies