Study of safety and efficacy of AEB071 and everolimus in patients withCD79-mutant or ABC subtype Diffuse Large B-Cell Lymphoma (DLBCL)
- Conditions
- Diffuse Large B-cell Lymphoma (DLBCL)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-001265-16-IT
- Lead Sponsor
- ovartis Farma S.p.A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 70
- Written informed consent obtained prior to any screening procedures and must be willing and able to comply with the protocol
- Male or female patients =18 years of age
- Diffuse large B-cell lymphoma with activating mutations in CD79 (A or B subunits) or patients who are determined to be ABC-subtype diffuse large B-cell lymphoma. (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 or who did not respond to chemotherapy may be considered for the study following a single regimen of chemotherapy such as R-CHOP or R-EPOCH. There is no limit to number of prior therapies allowed.
1. Patients may be treated with localized radiation as long as measurable or evaluable disease remains at untreated sites
2. Patients may be treated with corticosteroids immediately prior to enrollment and during the course of study treatment as long as steroid treatment is tapered to a total daily dosage of 10mg or less of prednisone (or its equivalent) prior to AEB071 and RAD001 administration
- WHO performance status of = 2
- Potential patients must have a representative FFPE tumor sample with enough material available to determine CD79 mutational status, molecular subtype status, and for gene sequencing, along with a corresponding pathology report. An archival tumor sample may be submitted, however if not available, a new tumor obtained for the purpose of this study must be submitted instead.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45
- Patients at screening who are treated with strong inducers or inhibitors of cytochrome P450 3A4/5 (CYP3A4/5), or CYP3A4/5 substrates with a QT prolongation risk that cannot be discontinued
- Impaired cardiac function or clinically significant cardiac diseases
- Patients with impairment of GI function or GI disease that could interfere with the absorption of AEB071 or RAD001
- Patients with severe systemic infections, current or within the two weeks prior to initiation of
- AEB071 Patients with a known history of Human Immunodeficiency Virus (HIV)
- Patients with poorly controlled diabetes as defined by a fasting serum glucose > 2.0 x ULN
- Pregnant or nursing (lactating) women or women of child-bearing potential unless they are using highly effective methods of contraception during dosing and for a period after treatment is complete
- Patients with evidence of current central nervous system (CNS) involvement. Patients who have only had prophylactic intrathecal or intravenous chemotherapy against CNS disease are eligible.
- Significant symptomatic deterioration of lung function. If clinically indicated pulmonary function tests including measure of predicated lung volumes, such as diffusing capacity of the lung for carbon monoxide, and oxygen saturation at rest on room air, should be considered to exclude restrictive lung disease; pneumonitis or pulmonary infiltrates.
- Other exclusion criteria apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method