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An Open-Label, Single-arm, Phase I Study of AEB071 (a Protein Kinase C Inhibitor) in Patients With CD79-mutant Diffuse Large B-Cell Lymphoma

Phase 1
18 Years
Open (Enrolling)
Diffuse Large B-Cell Lymphoma

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Trial Information

An Open-Label, Single-arm, Phase I Study of AEB071 (a Protein Kinase C Inhibitor) in Patients With CD79-mutant Diffuse Large B-Cell Lymphoma

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- Presence of unstable atrial fibrillation (ventricular response > 100 bpm); Patients
with stable atrial fibrillation are eligible, provided they do not meet any of the
other cardiac exclusion criteria.

- Angina pectoris or acute myocardial infarction ≤ 3 months prior to starting study

- 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

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency of Dose Limiting Toxicity (DLT) during cycle 1 (Dose Escalation phase)

Outcome Time Frame:

Cycle 1 (28 days)

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

July 2014

Related Keywords:

  • Diffuse Large B-Cell Lymphoma
  • Diffuse Large B-Cell Lymphoma,
  • Phase 1,
  • CD79 Mutation
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse



City of Hope National Medical Center Los Angeles, California  91010
Washington University School Of Medicine-Siteman Cancer Ctr Div. of Medical Oncology St. Louis, Missouri  63110
Hackensack University Medical Center Hackensack (SC) Hackensack, New Jersey  07601
Memorial Sloan Kettering Cancer Center MSK 2 New York, New York  10021
Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State Columbus, Ohio  43210
MD Anderson Cancer Center/University of Texas SC Location Houston, Texas  77030-4009