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An Open-Label, Single-arm, Phase Ib/II Study of AEB071 (a Protein Kinase C Inhibitor) and Everolimus (mTOR Inhibitor) in Patients With CD79-mutant or ABC Subtype Diffuse Large B-Cell Lymphoma

Phase 1/Phase 2
18 Years
Not Enrolling
CD79 Mutant or ABC-subtype Diffuse Large B-Cell Lymphoma

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Trial Information

An Open-Label, Single-arm, Phase Ib/II Study of AEB071 (a Protein Kinase C Inhibitor) and Everolimus (mTOR Inhibitor) in Patients With CD79-mutant or ABC Subtype Diffuse Large B-Cell Lymphoma

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of dose limiting toxicities (DLT) during the first cycle - Phase Ib

Outcome Description:

Estimate the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of the AEB071and RAD001 combination therapy in patients with DLBCL.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

September 2013

Completion Date:

July 2016

Related Keywords:

  • CD79 Mutant or ABC-subtype Diffuse Large B-Cell Lymphoma
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse