Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diffuse large B-cell lymphoma (DLBCL) with activating mutations in CD79 (A or B subunits). DLBCL that arose from transformed indolent lymphoma is allowed.
Prior treatment and relapse following anthracycline-based chemotherapy and autologous bone marrow or stem cell transplant. Patients who are not transplant eligible may be considered for the study following a single regimen of chemotherapy such as R-CHOP or R-EPOCH alone. There is no limit to prior therapy allowed.
* Patients may be treated with localized radiation to as many as two sites of disease, so long as measurable or evaluable disease remains at untreated sites.
* Patients may be treated with corticosteriods immediately prior to enrollment and during the course of the study treatment as long as steriod treatment is tapered to a toal daily dosage of 10mg or less of prednisone (or it's equivalent) prior to AEB071 administration
WHO performance status of ≤2
You may not be if
Patients at screening who are treated with strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) that can not be discontinued.
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
History or presence of ventricular tachyarrhythmia
Angina pectoris or acute myocardial infarction ≤ 3 months prior to starting study drug
Other clinically significant heart disease (e.g., symptomatic congestive heart failure; uncontrolled arrhythmia or hypertension; history of labile hypertension or poor compliance with an antihypertensive regimen)
Patients with another malignancy that was treated within the last three years with the exceptions of localized basal cell carcinoma and cervical carcinoma.
Patients with impairment of GI function or GI disease that could interfere with the absorption of AEB071.
Patients with a known history of Human Immunodeficiency Virus (HIV)
* HIV testing is not required as part of this study
Patients with a known history of active hepatitis B or C infection unless they are on antiviral therapy
* The determination of active hepatitis status should be as per standard of care at each site
* Hepatitis B and C testing is not required as part of this study
Time since the last prior therapy for treatment of underlying malignancy\*\*:
Cytotoxic chemotherapy: ≤ than the duration of the most recent cycle of the previous regimen (with a minimum of 2 weeks for all)
Biologic therapy (e.g., antibodies): ≤ 4 weeks
≤ 5 x t1/2 of a small molecule therapeutic, not otherwise defined above
\*\*Patients must have recovered or stabilized from all toxicities related to their previous treatment except for alopecia
Patients with any history of significant coagulopathy or a medical condition requiring long term systemic anticoagulation that would interfere with biopsies.
Patients having undergone major surgery less than 4 weeks prior to enrollment or that have not fully recovered from prior surgery.
Pregnant or nursing (lactating) women
Clareo Health | Study of AEB071 (a Protein Kinase C Inhibitor) in Patients With CD79-mutant Diffuse Large B-Cell Lymphoma
