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)
Study ID:
M19-063ClinicalTrials.gov ID:
NCT04161885EudraCT ID:
Not AvailableEU CT ID:
2023-507222-17-00Call us @: 844 663-3742
Study Details
Medical Condition
Study Phase
Intervention Type
Date
Participation Requirements
Gender
Age
Healthy Volunteers
Inclusion Criteria
Exclusion Criteria
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| Location | Status | Site Contact Details |
|---|---|---|
Location Arizona Oncology - Scottsdale - Cancer Transplant Institute, Scottsdale, Arizona, 85258-4547 | Status Not Available | |
Location University of Arizona Cancer Center - Tucson, Tucson, Arizona, 85724 | Status Not Available | |
Location University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205 | Status Not Available | |
Location City of Hope, Duarte, California, 91010 | Status Not Available | |
Location UCHSC Anschultz Cancer Pavilion, Aurora, Colorado, 80045-2517 | Status Not Available | |
Location Colorado Blood Cancer Institute, Denver, Colorado, 80218 | Status Not Available | |
Location Mayo Clinic, Jacksonville, Florida, 32224 | Status Not Available | |
Location AdventHealth Medical Group Blood & Marrow Transplant at Orlando, Orlando, Florida, 32804-5505 | Status Not Available | |
Location Ann & Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois, 60611 | Status Not Available | |
Location The University of Chicago Medical Center, Chicago, Illinois, 60637-1443 | Status Not Available | |
Location Loyola University Medical Ctr, Maywood, Illinois, 60153 | Status Not Available | |
Location Indiana Blood & Marrow Transpl, Indianapolis, Indiana, 46237 | Status Not Available | |
Location Duplicate_Ochsner Clinic Foundation-New Orleans, New Orleans, Louisiana, 70121 | Status Not Available | |
Location University of Maryland, Baltimore, Baltimore, Maryland, 21201 | Status Not Available | |
Location Massachusetts General Hospital, Boston, Massachusetts, 02114 | Status Not Available | |
Location Karmanos Cancer Institute - Dresner Clinic, Detroit, Michigan, 48201-2013 | Status Not Available | |
Location Masonic Cancer Center, Minneapolis, Minnesota, 55455 | Status Not Available | |
Location Mayo Clinic - Rochester, Rochester, Minnesota, 55905-0001 | Status Not Available | |
Location University of Mississippi Medical Center, Jackson, Mississippi, 39216-4500 | Status Not Available | |
Location The John Theurer Cancer, Hackensack, New Jersey, 07601 | Status Not Available | |
Location Montefiore Medical Center - Moses Campus, Bronx, New York, 10467 | Status Not Available | |
Location Roswell Park Cancer Institute, Buffalo, New York, 14263 | Status Not Available | |
Location Columbia University Medical Center, New York, New York, 10032-3729 | Status Not Available | |
Location Memorial Sloan Kettering Cancer Center-Koch Center, New York, New York, 10065-6007 | Status Not Available | |
Location Weill Cornell Medical College, New York, New York, 10065 | Status Not Available | |
Location University of North Carolina, Chapel Hill, North Carolina, 27514 | Status Not Available | |
Location Wake Forest Univ HS, Winston-Salem, North Carolina, 27157 | Status Not Available | |
Location UC Health - Cincinnati, Cincinnati, Ohio, 45267-2800 | Status Not Available | |
Location University Hospitals - Seidman Cancer Center, Cleveland, Ohio, 44106-1716 | Status Not Available | |
Location University of Oklahoma, Stephenson Cancer Center, Oklahoma City, Oklahoma, 73104-5418 | Status Not Available | |
Location Oregon Health and Science University, Portland, Oregon, 97239 | Status Not Available | |
Location Penn State Hershey Medical Ctr, Hershey, Pennsylvania, 17033-2360 | Status Not Available | |
Location Children's Hospital of Philadelphia - Main, Philadelphia, Pennsylvania, 19104-4319 | Status Not Available | |
Location Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, 19104 | Status Not Available | |
Location Duplicate_Allegheny General Hospital, Pittsburgh, Pennsylvania, 15212 | Status Not Available | |
Location UPMC Hillman Cancer Ctr, Pittsburgh, Pennsylvania, 15232 | Status Not Available | |
Location TriStar Centennial Medical Center, Nashville, Tennessee, 37203-1551 | Status Not Available | |
Location Texas Oncology - Medical City Dallas, Dallas, Texas, 75230 | Status Not Available | |
Location Texas Oncology- Baylor Charles A. Sammons Cancer Center, Dallas, Texas, 75246-2003 | Status Not Available | |
Location Texas Transplant Institute, San Antonio, Texas, 78229 | Status Not Available | |
Location Virginia Commonwealth University Medical Center Main Hospital, Richmond, Virginia, 23219 | Status Not Available | |
Location Fred Hutchinson Cancer Research Center, Seattle, Washington, 98109-1024 | Status Not Available | |
Location Univ of Wisconsin Hosp/Clinics, Madison, Wisconsin, 53792-0001 | Status Not Available | |
Location Vancouver Coastal Health Research Institute (VCHRI), Vancouver, British Columbia, V5Z 1M9 | Status Not Available | |
Location University Health Network_Princess Margaret Cancer Centre, Toronto, Ontario, M5G 2M9 | Status Not Available | |
Location CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont, Montreal, Quebec, H1T 2M4 | Status Not Available | |
Location Royal Victoria Hospital, Montreal, Quebec, H4A 3J1 | Status Not Available | |
Location Saskatoon Cancer Centre, Saskatoon, Saskatchewan, S7N 4H4 | Status Not Available |
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).
Number of Participants With Dose-Limiting Toxicities (DLTs) Following Administration of Venetoclax and Azacitidine (Part 1)
Time Frame: Up to the first treatment cycle (28 days)
Overall Survival (OS) (Part 2)
Time Frame: Up to 45 months after the first participant is randomized
Morphologic Relapse-Free Survival (RFS) (Part 2)
Time Frame: Up to 39 months after the first participant is randomized
Composite Relapse-Free Survival (RFS) (Part 2)
Time Frame: Up to 39 months after the first participant is randomized
Graft-versus-Host Disease (GvHD)-free, Relapse Free Survival (GRFS) (Part 2)
Time Frame: Up to 39 months after the first participant is randomized
Graft-versus-Host Disease (GvHD) Rate (Part 2)
Time Frame: Up to 39 months after the first participant is randomized
Change from Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) (Part 2)
Time Frame: Up to 39 months after the first participant is randomized
Change From Randomization in Fatigue in Adult Participants (Part 2)
Time Frame: Up to 39 months after the first participant is randomized
Measurable Residual Disease (MRD) Response Rate in Participants With MRD >= 10^-3 at Randomization (Part 2)
Time Frame: Up to 39 months after the first participant is randomized
Time to Deterioration in Global Health Status (GHS)/Quality of Life (QoL) in Adult Participants (Part 2)
Time Frame: Up to 39 months after the first participant is randomized
Change in Patient Reported Signs, Symptoms and Impact of Acute Myeloid Leukemia (AML) as Measured by the European Quality-of-Life-5 Dimensional-5-Level (EQ-5D-5L)
Time Frame: Up to 39 months after the first participant is randomized
Interventions:
- Drug: Venetoclax
- Drug: Venetoclax
- Drug: Azacitidine
- Drug: Azacitidine
- Other: Best Supportive Care (BSC)
- Other: Best Supportive Care (BSC)
- Other: Best Supportive Care (BSC)
Enrollment:
465
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