Evaluate the safety and tolerability of pegcrisantaspase in combination with venetoclax
(Ven-PegC) and estimate the maximum tolerated doses and/or biologically active doses of
Ven-PegC in patients with relapsed or refractory acute myeloid leukemia (R/R AML)
This research study is a non-randomized, open-label Phase Ib clinical trial evaluating
venetoclax (Ven) administered orally daily in combination with pegcrisantaspase (PegC)
administered IV biweekly, as part of a 28-day treatment cycle in adult subjects with relapsed
or refractory acute myeloid leukemia (R/R AML).
The trial will consist of dose escalation to evaluate the safety and tolerability of Ven-PegC
and estimate the maximum tolerated doses (MTDs) and/or biologically active doses (e.g.
recommended phase 2 doses [RP2Ds]) of Ven-PegC in patients with R/R AML
Venetoclax is an FDA (the U.S. Food and Drug Administration) approved drug, but this
combination ( Ven-PegC) has not been approved by the FDA.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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