Adding Venetoclax to the High-dose Chemotherapy Regimen Prior to Mismatche Allogeneic Stem Cell Transplant
Reason given: Unable to accommodate FDA recommendations for protocol revisions
Key facts
- Where
- Atlanta, United StatesSee the site
- Phase
- Phase 2
Where in United States
- Caitlin GuzowskiAtlanta, United StatesNo longer taking part
Trial details
- Who runs it
- Northside Hospital, Inc.
- Trial code
- NCT06337331
- Record updated
- 14 June 2024
- Original description
Patients eligible for a mismatch allogeneic stem cell transplant will receive Venetoclax daily for 7 days prior to transplant in addition to the following chemotherapy regimen: Decitabine daily for 5 days, Fludarabine daily for 5 days, and Busulfan daily for 2 days followed by 1 day of total body irradiation. Stem cell transplant will occur thereafter.Read full original descriptionShow less
A Phase II Trial of Venetoclax-Enhanced Reduced Intensity HLA-Mismatched Allogeneic Transplant for Ultra-High-Risk Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
Patients eligible for a mismatch allogeneic stem cell transplant will receive Venetoclax daily for 7 days prior to transplant in addition to the following chemotherapy regimen: Decitabine daily for 5 days, Fludarabine daily for 5 days, and Busulfan daily for 2 days followed by 1 day of total body irradiation. Stem cell transplant will occur thereafter.
Inclusion: Availability of a 4/8 - 6/8 HLA-matched related donor or a 7/8 HLA-matched unrelated donor; Receiving first allogeneic transplant; KPS >/= 70%; MDS associated with TP53 mutation AND R-IPSS high or very high risk at diagnosis OR; AML with adverse risk cytogenetics or molecular abnormalities according to the 2017 ELN risk stratification OR pre-transplant MRD by either flow cytometry, cytogenetics or FISH; Less than 5% myeloblasts in the marrow pre-transplant.
Exclusion: Patient requiring treatment with a moderate or strong inhibitor or inducer of CYP3A4 or a P-gp inhibitor within 7 days prior to starting preparative chemotherapy through Day +4 post-transplant; Ongoing or active systemic infection, active Hepatitis B or C virus infection, or known HIV positivity; Poor cardiac function defined as LVEF <45%; Poor liver function defined as bilirubin >/=2.5mg/dL, AST/ALT >3xULN; Poor renal function defined as creatinine >/=2.0mg/dL or CrCl <40mL/min; Poor pulmonary function defined as FEV1, FVC, or DLCO <50% predicted.