A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine After Allogeneic Stem Cell Transplantation in Subjects With Acute Myeloid Leukemia (AML) (VIALE-T)
A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine After Allogeneic Stem Cell Transplantation in Subjects With Acute Myeloid Leukemia (AML) (VIALE-T)
The main objective of this study is to evaluate the efficacy of venetoclax in combination with azacitidine to improve Overall Survival (OS) in Acute Myeloid Leukemia (AML) participants compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation (SCT).
This study will have 2 parts: Part 1 (Dose Confirmation), which may include participants who are greater than or equal to 18 years old; Part 2 (Randomization) which may include participants who are greater than or equal to 12 years old. During Part 1, recommended Phase 3 dose of venetoclax in combination with azacitidine will be determined and during Part 2, the efficacy and safety of venetoclax with azacitidine (Part 2 Arm A) will be compared with BSC (Part 2 Arm B).
Inclusion Criteria:
Exclusion Criteria:
Scottsdale, Arizona 85258-4547, United States
Orlando, Florida 32804-5505, United States
Chicago, Illinois 60611, United States
New Orleans, Louisiana 70121, United States
New York, New York 10065-6007, United States
Winston-Salem, North Carolina 27157, United States
Oklahoma City, Oklahoma 73104-5418, United States
Philadelphia, Pennsylvania 19104-4319, United States
Philadelphia, Pennsylvania 19104, United States
Dallas, Texas 75246-2003, United States
Richmond, Virginia 23219, United States
Jaú, São Paulo 17210-070, Brazil
São Paulo, 05403-000, Brazil
Vancouver, British Columbia V5Z 1M9, Canada
Toronto, Ontario M5G 2M9, Canada
Montreal, Quebec H1T 2M4, Canada
Montreal, Quebec H4A 3J1, Canada
Wuhan, Hubei 430022, China
Wuhan, Hubei 430022, China
Xi’an, Shanxi 710038, China
Tianjin, Tianjin Municipality 300020, China
Hangzhou, Zhejiang 310003, China
Hradec Králové, Hradec Kralove 500 05, Czechia
Nantes, Pays de la Loire Region 44000, France
RION Patras Achaia, 26504, Greece
Turin, Piedmont 10126, Italy
Rome, Roma 00168, Italy
Anjo-shi, Aichi-ken 446-8602, Japan
Nagoya, Aichi-ken 453-8511, Japan
Yoshida-gun, Fukui 910-1104, Japan
Hiroshima, Hiroshima 730-8619, Japan
Nishinomiya-shi, Hyōgo 663-8501, Japan
Sakai-shi, Osaka 590-0197, Japan
Saitama-shi, Saitama 330-8503, Japan
Shimotsuke-shi, Tochigi 329-0498, Japan
Bunkyo-ku, Tokyo 113-8677, Japan
Chuo-ku, Tokyo 104-0045, Japan
Minato-ku, Tokyo 105-8470, Japan
Setagaya-ku, Tokyo 157-8535, Japan
Shinjuku-ku, Tokyo 160-8582, Japan
Seoul, Seoul Teugbyeolsi 06591, South Korea
Taipei City, Taipei 100, Taiwan
London, Greater London SE5 9RS, United Kingdom