A Phase Ib/II Study of AEB071 and Everolimus in Patients with CD79-Mutant or ABC Diffuse Large B-Cell Lymphoma

Protocol
13-225
Full Title
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
I/II
Purpose

Activated B-cell (ABC) type diffuse large B-cell lymphoma (DLBCL) is a more aggressive form of the disease than non-ABC type DLBCL. Some DLBCL contain a mutated form of the CD79 gene. Both of these types of DLBCL have increased activity in certain cellular pathways that can promote tumor growth.

In this study, researchers are evaluating a combination of two drugs to treat ABC type DLBCL and CD79-mutant DLBCL. One is an investigational drug called AEB071, which works by inhibiting protein kinase C, an enzyme which fuels cancer growth. The other drug is everolimus, which inhibits cancer growth by targeting a protein called mTOR. Everolimus is approved for treating advanced kidney cancer, but its use for DLBCL is considered investigational.

Both AEB071 and everolimus are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have ABC type DLBCL or CD79-mutant DLBCL that has persisted or returned despite therapy.
  • Patients may participate if their disease has not responded to or has returned after standard initial therapy, and they have not responded to or were not candidates for a stem cell transplant. Patients may have had any number of previous therapies, but may not have previously received a PI3 kinase inhibitor, mTOR inhibitor, or radioimmunotherapy.
  • Patients should recover from the serious side effects of previous treatment before they enter the study.
  • This study is open to patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. John Gerecitano at 212-639-3748.

Disease(s)
Lymphoma: Non-Hodgkin's Lymphoma
Locations
Related Diseases