This is a Phase Ib Study to determine the Maximum Tolerated Dose (MTD) of Venetoclax in
combination with Gemtuzumab Ozogamicin(GO) in subjects with relapsed/refractory acute myeloid
leukemia. Using a standard 3+3 design, subjects will receive once cycle of combination
therapy. After one cycle of combination therapy, subjects showing response will continue on
to one cycle of consolidation therapy with GO\Veneoclax. Subjects who respond to combination
therapy will continue on maintenance Venetoclax until progression or unacceptable toxicity.
Dose-limiting toxicity, defined as an adverse event related (possible, probably, or definite)
to Venetoclax and/or Gemtuzumab fulfilling one of the following criteria:
Hematologic toxicity: treatment-related grade 4 or worse bone marrow hypocellularity
present at the end of cycle one (day 28); specifically grade 4 cytopenias (anemia,
neutropenia and/or thrombocytopenia) with the bone marrow documented to be free of
leukemic infiltration. Note: patients who enter the study with grade 3 or worse
cytopenias will not be evaluable for hematologic dose-limiting toxicities.
Non-hematologic toxicity: any grade 3 or worse treatment-related toxicity (excluding
grade 4 infections during cycle one).
The study will also evaluate the Overall Response Rate, Anti-leukemic activity, Relapse-free
Survival (RFS), event-free survival (EFS) , and overall survival (OS). The study will
evaluate quality of life using the European Organization for the Research and Treatment of
Cancer 30 item questionnaire (EORTC QLQ-C30).
Clinical Study Identifier
Last Modified on
24 November 2020
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