paxbible.blogg.se - Sct pro racer free trial

Participant has known infection with HIV or history of being positive for hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.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).

History of disease progression during prior treatment with venetoclax.

Blast percentage in bone marrow before transplant must be = 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.

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 45 days.

Participants must be at least 18 years old for Part 1 and, at least 12 years old for Part 2.Condition or diseaseĭrug: Venetoclax Drug: Azacitidine Other: Best Supportive Care (BSC)Įxpanded Access : An investigational treatment associated with this study is available outside the clinical trial. 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). 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. 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). Why Should I Register and Submit Results?.