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) VENETOCLAX-ENHANCED REDUCED INTENSITY CONDITIONING

What's the purpose of this trial?

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.

This is an upcoming trial that has not yet started accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

* 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 Criteria:

* Poor cardiac function defined as LVEF \<45%
* Poor pulmonary function defined as FEV1, FVC, or DLCO \<50% predicted
* 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
* Ongoing or active systemic infection, active Hepatitis B or C virus infection, or known HIV positivity
* 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

Additional Trial Information

Phase 2

Enrollment: 23 patients (estimated)

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Trial Locations

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Georgia

Northside Hospital (Atlanta)

Atlanta, GA

Not Yet Accepting
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