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A Safety and Efficacy Study of Oral Venetoclax Tablets and Injectable Azacitidine Versus Best Supportive Care as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy to Evaluate Improveme

2019-09-30 07:07:12 | BioPortfolio

Summary

The main objective of this study is to evaluate safety and efficacy of venetoclax in combination with azacitidine (AZA) compared to best supportive care (BSC) as maintenance therapy in adult participants with acute myeloid leukemia (AML) in first remission after conventional chemotherapy. This study takes place in 2 parts evaluating improvement in relapse-free survival (RFS): Part 1 (Dose confirmation) and Part 2 (Randomization). Part 2 begins after safety is assessed in Part 1 for approximately 4 weeks. During this study, participants will receive venetoclax and azacitidine or best supportive care for approximately 2 years with study visits varying from 1-5 per month.

Study Design

Conditions

Acute Myeloid Leukemia (AML)

Intervention

Venetoclax, Azacitidine, Best Supportive Care (BSC)

Location

Ochsner Clinic Foundation-New Orleans /ID# 214583
New Orleans
Louisiana
United States
70121

Status

Not yet recruiting

Source

AbbVie

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-30T07:07:12-0400

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