A Study of Venetoclax and AMG 176 in Patients With Relapsed/Refractory Hematologic Malignancies

AbbVie

Status and phase

Terminated

Phase 1

Conditions

Non-Hodgkin's Lymphoma

Diffuse Large B-cell Lymphoma

Acute Myeloid Leukemia

Treatments

Drug: Venetoclax

Drug: AMG 176

Study type

Interventional

Funder types

Industry

Identifiers

NCT03797261

2018-003314-41 (EudraCT Number)

M16-785

Details and patient eligibility

About

This dose-escalation study evaluating the safety, pharmacokinetics and preliminary efficacy of venetoclax in combination with AMG 176 in participants with relapsed or refractory acute myeloid leukemia (AML) and participants with Non-Hodgkin's lymphoma (NHL)/diffuse large B-cell lymphoma (DLBCL).

This study will include a dose escalation phase to identify the maximum tolerated dose/recommended phase 2 dose (MTD/RPTD) of venetoclax plus AMG 176 as well as a dose expansion phase to confirm safety, explore efficacy, and confirm the suitability of the preliminary RPTD.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adequate kidney, liver and hematology values as described in the protocol.
Diagnosis of relapsed or refractory (R/R) acute myeloid leukemia (AML) or R/R Non-Hodgkin's lymphoma (NHL)/diffuse large B-cell lymphoma (DLBCL) confirmed by the World Health Organization (WHO) criteria, as appropriate.
Meets the following disease activity criteria:
AML: must have received at least 1 prior therapy for AML and be ineligible for cytotoxic therapy and allogeneic stem cell transplant.
NHL/DLBCL: measurable disease with a bidimensional lesion measuring at least 1.5 cm; received at least 1 prior therapy for NHL with no curative treatment option as determined by the investigator and be ineligible for a stem cell transplant.

Exclusion criteria

History of clinically significant medical condition that, in the opinion of the investigator, would adversely affect participation in this study.
History of of any malignancy within the last 6 months except for those specified in this protocol and low-grade malignancies not requiring active treatment such as non-melanoma skin cancer, cervical intraepithelial neoplasia, or prostate cancer in situ.
Prior allogeneic stem cell transplant or autologous stem cell transplant within 100 days of study drug administration and no signs or symptoms of acute or chronic graft-versus-host disease.
Previous enrollment in a randomized trial including either venetoclax or AMG 176.
Known active or chronic pancreatitis; severe chronic obstructive pulmonary disease with hypoxemia; central nervous system manifestations of malignancy.
Active, uncontrolled infection.