Trials / Completed
CompletedNCT04509622
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)
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Venetoclax | Tablet; Oral |
| DRUG | Cytarabine | Subcutaneous Injection |
Timeline
- Start date
- 2020-10-05
- Primary completion
- 2021-04-15
- Completion
- 2021-04-15
- First posted
- 2020-08-12
- Last updated
- 2022-05-05
Locations
16 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT04509622. Inclusion in this directory is not an endorsement.