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)

AbbVie14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Myeloid Leukemia (AML)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (16)

NHO Nagoya Medical Center /ID# 223671

Nagoya, Aichi-ken, Japan

Aichi Cancer Center Hospital /ID# 223134

Nagoya, Aichi-ken, Japan

University of Fukui Hospital /ID# 223133

Yoshida-gun, Fukui, Japan

Kyushu University Hospital /ID# 223136

Fukuoka, Fukuoka, Japan

Gunmaken Saiseikai Maebashi Hospital /ID# 223301

Maebashi, Gunma, Japan

National Hospital Organization Mito Medical Center /ID# 223392

Higashi Ibaraki-gun, Ibaraki, Japan

Hitachi General Hospital /ID# 223084

Hitachi-shi, Ibaraki, Japan

University Hospital Kyoto Prefectural University of Medicine /ID# 223135

Kyoto, Kyoto, Japan

Tohoku University Hospital /ID# 223169

Sendai, Miyagi, Japan

Okayama University Hospital /ID# 222990

Okayama, Okayama-ken, Japan

...and 6 more locations

Outcomes

Primary Outcomes

Number of Participants with Adverse Events (AEs)

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

Time frame: Up to approximately 9 months after the first participant receives first dose of study drug