Phase Ib study of the safety and efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in patients with relapsed or refractory CD33+ acute myeloid leukemia: Big Ten Cancer Research Consortium BTCRC-AML17-113
Categories (click each to see list of all clinical trials associated with that category): Leukemia/MDS/MPD (ONC)
Current Status: Open
Phase: I
Principal Investigator: Bhatt, Vijaya
Contact Information:
Marnee Strege
+1 402-559-8155
marnee.strege@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT04070768?term=%09NCT04070768&rank=1
Summary
Maximum Tolerated Dose (MTD) of Venetoclax when administered with GO [ Time Frame: 42 days ]
Assess the maximum tolerated dose (MTD) of Venetoclax when administered with GO in patients with AML.
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.
Secondary Outcome Measures :
Overall response rate [ Time Frame: 7 months ]
Overall response rate (CR/CRi), as defined by the revised IWG criteria
Rate of Anti-leukemic activity [ Time Frame: 7 months ]
Anti-leukemic activity (CR/Cri/PR), as defined by the revised IWG criteria
Relapse-free survival [ Time Frame: 7 months ]
patients achieving CR or CRi; measured from the date of achievement of a remission until the date of relapse or death from any cause; patients not known to have relapsed or died at last follow-up are censored on the date they were last examined
Event-free Survival [ Time Frame: 7 months ]
Event-free Survival will be measured from the date of entry to the date of treatment failure, disease relapse, or death from any cause; patients not known to have any of these events are censored on the date they were last examined
overall survival [ Time Frame: 7 months ]
Overall survival will be measured from the date of entry to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive