Phase 2
N=78
Safety and Efficacy Study of a BTK Inhibitor in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma
Diffuse Large Cell B-lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01325701 ↗Enrolled (actual)
78
Serious AEs
55.1%
Results posted
Feb 2017
Primary outcome: Primary: Percentage of Patients With an Overall Response to Study Drug — 24.3; 12.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ibrutinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pharmacyclics LLC.
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With an Overall Response to Study Drug |
24.3; 12.5 | — |
| SECONDARY Number of Patients With Adverse Events as a Measure of Safety and Tolerability |
70; 8 | — |
| SECONDARY Ibrutinib and Its Metabolite (PCI-45227) AUC0-24h After Repeat Dosing of PCI-32765 |
1285; 1337; 1485; 1671 | — |
Summary
The purpose of this study is to evaluate the efficacy of ibrutinib (PCI-32765) in relapsed/refractory de novo activated B-cell (ABC) and germinal-cell B-Cell (GCB) Diffuse Large B-cell Lymphoma (DLBCL).
Eligibility Criteria
Inclusion Criteria
- Men and women ≥ 18 years of age.
- ECOG performance status ≤ 2.
- Pathologically confirmed de novo DLBCL
- Subjects must have available tissue for central pathology review to be eligible. Treatment Group 2: Subjects will be eligible if they have the non-GCB phenotype, as confirmed by Central IHC testing by the Hans method.
- Relapsed or refractory disease, defined as either: 1) recurrence of disease after a CR, or 2) PR, SD, or progressive disease (PD) at completion of the treatment regimen preceding entry to the study (residual disease): Subjects must have previously received an appropriate first-line treatment regimen. Subjects who have not received HDT/ASCT must be ineligible for HDT/ASCT
- Treatment Group 1: Subjects must have ≥ 1 measurable (> 2 cm in longest dimension) disease sites on CT scan. Treatment Group 2: Subjects must have ≥ 1 measurable (> 1.5 cm in longest dimension) disease sites on CT scan.
Exclusion Criteria
- Transformed DLBCL or DLBCL with coexistent histologies (eg, FL or MALT).
- Primary mediastinal (thymic) large B-cell lymphoma.
- Known central nervous system lymphoma. In addition, for subjects in Treatment Group 2, known leptomeningeal involvement is exclusionary.
- Certain exclusions on prior therapy
- Major surgery within 2 weeks of first dose of study drug.
- Any of the following laboratory abnormalities:
- ANC 2.0 x ULN
- Treatment Group 2 only: Hemoglobin 1.5 x ULN
- Requires or has received anticoagulation treatment with warfarin or equivalent Vitamin K antagonists (eg, phenprocoumon)
- Treatment Group 2: Requires treatment with a strong cytochrome P450 (CYP) 3A4/5 inhibitor
- Treatment Group 2: Known bleeding diathesis, eg, von Willebrand's disease, hemophilia.
Data sourced from ClinicalTrials.gov (NCT01325701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.