Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pharmacyclics LLC.
The primary objectives of this study were to evaluate the efficacy of ibrutinib administered at 560 mg once per day in relapsed or refractory de novo ABC and GCB DLBCL, and to evaluate the efficacy of ibrutinib administered at 840 mg once per day in relapsed or refractory de novo ABC DLBCL.
The secondary objective was to evaluate the safety and tolerability of a fixed daily oral dosing regimen of ibrutinib in relapsed/refractory de novo DLBCL.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Men and women ≥ 18 years of age.
2. ECOG performance status ≤ 2.
3. Pathologically confirmed de novo DLBCL
5. 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
6. 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.
You may not be if
1. Transformed DLBCL or DLBCL with coexistent histologies (eg, FL or MALT).
2. Primary mediastinal (thymic) large B-cell lymphoma.
3. Known central nervous system lymphoma. In addition, for subjects in Treatment Group 2, known leptomeningeal involvement is exclusionary.
4. Certain exclusions on prior therapy
5. Major surgery within 2 weeks of first dose of study drug.
6. Any of the following laboratory abnormalities:
1. ANC \< 0.75 x 10\^9/L. Treatment Group 2: Eligible subjects must be independent of growth factor support for 7 days prior to the screening lab tests.
2. Platelet count \< 50 x 10\^9/L independent of transfusion support. Treatment Group 2 only: Eligible subjects must be independent of transfusion support for 7 days prior to the screening lab tests.
3. AST or ALT ≥ 3.0 x upper limit of normal (ULN)
4. Creatinine \> 2.0 x ULN
5. Treatment Group 2 only: Hemoglobin \< 8.0 g/dL
6. Treatment Group 2 only: Total Bilirubin \> 1.5 x ULN
7. Requires or has received anticoagulation treatment with warfarin or equivalent Vitamin K antagonists (eg, phenprocoumon)
8. Treatment Group 2: Requires treatment with a strong cytochrome P450 (CYP) 3A4/5 inhibitor
9. Treatment Group 2: Known bleeding diathesis, eg, von Willebrand's disease, hemophilia.
