Venetoclax in Combination with LDAC in Treatment-Naive Japanese AML Subjects in Expanded Access Study [M19-916]
Not Applicable
Completed
- Registration Number
- JPRN-jRCT2080225347
- Lead Sponsor
- AbbVie G.K.
- Brief Summary
Overall, venetoclax was well-tolerated in subjects with AML who were not eligible for intensive chemotherapy at Japanese sites. Venetoclax + LDAC has a favorable benefit-risk profile. The AEs are consistent with the known safety profile of venetoclax in the AML population and was successfully managed with standard medical treatment. No new safety signals were observed in the study. No subject reported TLS.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety
- Secondary Outcome Measures
Name Time Method