Acute Myeloid Leukemia Clinical Trial
A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML)
Summary
The main objective of this study is to evaluate the efficacy of venetoclax in combination with azacitidine to improve Relapse Free Survival (RFS) 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).
Eligibility Criteria
Inclusion Criteria:
Participants must be at least 18 years old for Part 1 and, at least 12 years old for Part 2.
Participant must be diagnosed with Acute Myeloid Leukemia (AML) by World Health Organization (WHO) criteria (2017) and either be planning for allogeneic stem cell transplantation or have received allogeneic stem cell transplantation within the past 60 days.
Blast percentage in bone marrow before transplant must be < 10%.
Blast count in peripheral blood must be "0" and Blast percentage in bone marrow must be < 5% after transplant.
Participant meet adequate renal, hepatic and hematologic criteria as described in the protocol.
Participants >= 17 years old must have a Karnofsky Performance Scale (KPS) score > 50 and participants between 12 to 16 years old must have a Lansky Play Performance Scale score > 40.
Exclusion Criteria:
History of disease progression during prior treatment with venetoclax.
History of any other malignancy within 2 years prior to study entry, except for: Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or treated with other modalities) with curative intent; Myelodysplastic Syndrome, Myeloproliferative neoplasm (only allowed if it transformed to AML and AML should be the indication for marrow transplantation).
Participant has known infection with HIV or history of being positive for hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
Presence of clinical or laboratory symptoms/signs of extramedullary myeloid malignancy.
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There are 162 Locations for this study
Scottsdale Arizona, 85258, United States
Tucson Arizona, 85724, United States
Little Rock Arkansas, 72205, United States
Jacksonville Florida, 32224, United States
Orlando Florida, 32804, United States More Info
Chicago Illinois, 60611, United States More Info
Chicago Illinois, 60637, United States
Indianapolis Indiana, 46237, United States
New Orleans Louisiana, 70121, United States More Info
Detroit Michigan, 48201, United States More Info
Minneapolis Minnesota, 55455, United States
Jackson Mississippi, 39216, United States
Bronx New York, 10467, United States
Buffalo New York, 14263, United States More Info
New York New York, 10032, United States
New York New York, 10065, United States
New York New York, 10065, United States
Chapel Hill North Carolina, 27514, United States
Winston-Salem North Carolina, 27157, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44106, United States
Oklahoma City Oklahoma, 73104, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19104, United States More Info
Dallas Texas, 75230, United States
Dallas Texas, 75246, United States More Info
Richmond Virginia, 23219, United States
Seattle Washington, 98109, United States More Info
Darlinghurst New South Wales, 2010, Australia
Adelaide South Australia, 5000, Australia
Melbourne Victoria, 3000, Australia
Melbourne Victoria, 3004, Australia
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Jaú Sao Paulo, 17210, Brazil
São Paulo Sao Paulo, 01409, Brazil
Sao Paulo , 05403, Brazil
Vancouver British Columbia, V5Z 1, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H1T 2, Canada
Montreal Quebec, H4A 3, Canada
Saskatoon Saskatchewan, S7N 4, Canada
Beijing Beijing, 10004, China
Beijing Beijing, 10085, China
Beijing Beijing, 86105, China
Fuzhou Fujian, 35000, China
Guangzhou Guangdong, 51008, China
Guangzhou Guangdong, 51028, China
Guangzhou Guangdong, 51051, China
Shenzhen Guangdong, 51802, China
Zhengzhou Henan, 45000, China
Wuhan Hubei, 43002, China
Wuhan Hubei, 43002, China
Changsha Hunan, 41000, China
Nanjing Jiangsu, 21000, China
Suzhou Jiangsu, 21500, China
Xuzhou Jiangsu, 22100, China
Nanchang Jiangxi, 33000, China
Xi'an Shaanxi, 71003, China
Shanghai Shanghai, 20043, China
Tianjin Tianjin, 30002, China
Hangzhou Zhejiang, 31000, China
Brno , 625 0, Czechia
Hradec Kralove , 500 0, Czechia
Ostrava , 708 5, Czechia
Praha , 128 0, Czechia
Nice Alpes-Maritimes, 06200, France
Besancon Doubs, 25030, France
Pessac Gironde, 33604, France
Lille Hauts-de-France, 59037, France
Nantes Pays-de-la-Loire, 44000, France
Paris , 75010, France
Paris , 75012, France
Paris , 75013, France
Heidelberg Baden-Wuerttemberg, 69120, Germany
Muenster Nordrhein-Westfalen, 48149, Germany
Leipzig Sachsen, 04103, Germany
Augsburg , 86156, Germany
Dresden , 01307, Germany
Halle (Saale) , 06120, Germany
Hannover , 30625, Germany
Wuerzburg , 97080, Germany
Athens Attiki, 10676, Greece
Athens Attiki, 12462, Greece
RION Patras Achaia , 26504, Greece
Debrecen Hajdu-Bihar, 4032, Hungary
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv-Yafo Tel-Aviv, 64239, Israel
Jerusalem Yerushalayim, 91120, Israel
Haifa , 31096, Israel
Petah Tikva , 49202, Israel
Petakh Tikva , 49414, Israel
Ramat Gan , 52621, Israel
Rome Lazio, 00161, Italy
Rome Lazio, 00168, Italy
Milan Milano, 20132, Italy
Milan Milano, 20141, Italy
Brescia , 25123, Italy
Turin , 10126, Italy
Anjo-shi Aichi, 446-8, Japan
Nagoya-shi Aichi, 453-8, Japan
Yoshida-gun Fukui, 910-1, Japan
Fukuoka-shi Fukuoka, 812-8, Japan
Fukushima-shi Fukushima, 960-1, Japan
Hiroshima-shi Hiroshima, 730-8, Japan
Sapporo-shi Hokkaido, 060-8, Japan
Kobe-shi Hyogo, 650-0, Japan
Nishinomiya-shi Hyogo, 663-8, Japan
Kanazawa-shi Ishikawa, 920-8, Japan
Kagoshima-shi Kagoshima, 890-0, Japan
Isehara-shi Kanagawa, 259-1, Japan
Yokohama-shi Kanagawa, 241-8, Japan
Kyoto-shi Kyoto, 606-8, Japan
Sendai-shi Miyagi, 98085, Japan
Okayama-shi Okayama, 700-8, Japan
Osaka-shi Osaka, 545-8, Japan
Osakasayama-shi Osaka, 589-8, Japan
Saitama-shi Saitama, 330-8, Japan
Shimotsuke-shi Tochigi, 329-0, Japan
Bunkyo-ku Tokyo, 113-8, Japan
Chuo-ku Tokyo, 104-0, Japan
Minato-ku Tokyo, 105-8, Japan
Setagaya-ku Tokyo, 157-8, Japan
Shinjuku-ku Tokyo, 160-8, Japan
Yamagata-shi Yamagata, 990-9, Japan
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Barcelona , 08036, Spain
Barcelona , 08041, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
Madrid , 28046, Spain
Sevilla , 41013, Spain
Valencia , 46010, Spain
Basel Basel-Stadt, 4031, Switzerland
Zurich Zuerich, 8091, Switzerland
Kaohsiung , 807, Taiwan
Taichung , 40447, Taiwan
Taichung , 40705, Taiwan
Taipei City , 100, Taiwan
Taipei , 11217, Taiwan
Taoyuan City , 333, Taiwan
Glasgow Scotland, G12 0, United Kingdom
Birmingham , B15 2, United Kingdom
London , NW1 2, United Kingdom
London , SE5 9, United Kingdom
London , SW3 6, United Kingdom
London , W2 1N, United Kingdom
Newcastle upon Tyne , NE7 7, United Kingdom
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