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)

Study Overview
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Brief Summary
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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.

Official Title
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An Expanded Access Study for Venetoclax in Combination With Low-Dose Cytarabine in Treatment-Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Intensive Induction Therapy in Japan

Conditions
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Acute Myeloid Leukemia (AML)

Intervention / Treatment
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* Drug: Venetoclax
* Drug: Cytarabine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Venetoclax + Low-Dose Cytarabine (LDAC)<br>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. | Drug: Venetoclax<br>* Tablet; Oral<br>* Other names: Venclexta;Drug: Cytarabine<br>* Subcutaneous Injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to approximately 9 months after the first participant receives first dose of study drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Myeloid Leukemia (AML), Cancer, Venetoclax, Venclexta