A Study of Oral Venetoclax Tablet in Combination With Subcutaneous Low-Dose Cytarabine (LDAC) Injection to Assess Adverse Events in Adult Japanese Participants With Acute Myeloid Leukemia (AML)

AbbVie

Status and phase: Completed; Phase 3

Conditions: Acute Myeloid Leukemia (AML)

Treatments: Drug: Cytarabine; Drug: Venetoclax

Study type: Interventional

Funder types: Industry

Identifiers

NCT04509622

M19-916

Details and patient eligibility

About

Acute Myeloid Leukemia (AML) is a cancer of the white blood cells which perform many functions, including fighting bacterial infections and defending the body against parasites. This study will evaluate how safe venetoclax is and assess the adverse events in adult participants with AML.

Venetoclax in combination with low-dose cytarabine (LDAC) is an approved therapy in the United States for patients with newly diagnosed acute myeloid leukemia (AML) aged > 18 years with a medical condition that prevents the use of intensive chemotherapy. This study provides access to venetoclax in combination with LDAC to participants over 18 years who are ineligible for intensive induction therapy. Around 38 adult participants with diagnosis of AML will be enrolled in approximately 15 sites across Japan.

Participants will receive oral venetoclax tablets once daily on days 1-28 in combination with subcutaneous low-dose cytarabine (LDAC) injections once daily on days 1-10 of the 28-day treatment cycles.

Participants will attend regular visits during the study at a hospital to evaluate safety by medical assessments and blood tests.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of AML, previously untreated, ineligible for intensive induction regimen due to age or co-morbidities.

• Participants who are >= 75 years of age or who are >= 18 to 74 years of age with at least one of the following co-morbidities:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3.
  • Cardiac history of congestive heart failure requiring treatment or ejection fraction <= 50% or chronic stable angina.
  • Diffusion capacity of lung for carbon monoxide (DLCO) <= 65% or forced expiratory volume during the first second (FEV1) <= 65%.
  • Adequate renal and hepatic criteria as described in the protocol.
  • Other co-morbidities that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the AbbVie Therapeutic Area Medical Director (TA MD) before study enrollment.

Exclusion criteria

• History of prior treatment for AML with the exception of hydroxyurea, allowed through the first cycle of study treatment.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

14 participants in 1 patient group

Venetoclax + Low-Dose Cytarabine (LDAC)

Experimental group

Description:

Participants will receive venetoclax once daily (QD) on days 1 through 28 plus LDAC QD on days 1 through 10 during the 28-day treatment cycles.

Treatment:

Drug: Cytarabine

Drug: Venetoclax