Pegcrisantaspase in Combination With Venetoclax for Treatment of Relapsed or Refractory Acute Mye… (NCT04666649) | Clinical Trial Compass
CompletedPhase 1
Pegcrisantaspase in Combination With Venetoclax for Treatment of Relapsed or Refractory Acute Myeloid Leukemia (R/R AML)
United States27 participantsStarted 2021-03-10
Plain-language summary
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)
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* A histologically or pathologically confirmed diagnosis of AML based on 2016 WHO classification. Patients with Complex Karyotype AML (CK-AML) and TP53-mutated AML are eligible for this study.
* AML has relapsed after or is refractory to, first-line therapy, with a maximum of three prior lines of therapy. Patients whose AML has FLT3 or IDH1/IDH2 mutations should have received at least one available FLT3 or IDH1/IDH2 inhibitors
* Age 18 years and older
* ECOG performance status ≤ 2
* Patients who have undergone allo-HSCT are eligible if they are ≥ 30 days post stem cell infusion, have no evidence of graft versus hose disease ( GVHD ) \> Grade 1, and are ≥ 10 days off all immunosuppressive therapy
* Previous cytotoxic chemotherapy must have been completed at least 10 days prior to day 1 of treatment on the study and all AEs (excluding alopecia, acne, rash) due to agents administered earlier should have recovered to \< Grade 1. Patients with hematologic malignancies are expected to have hematologic abnormalities at study entry. These abnormalities which are thought to be primarily related to the underlying leukemia, are not considered to be toxicities (AE) and do not need to resolve to \< Grade 1
* All biologic agents including hematopoietic growth factors must have been stopped at least 1 week prior to day 1 of treatment on the study
* Patients must have adequate organ function as defined below:
* Direct bilirubin ≤2X the institutional upper limit of nor…
What they're measuring
1
Incidence of regimen limiting toxicities (RLTs)
Timeframe: One year (after 12 cycle's treatment)
2
Incidence of treatment-emergent adverse events (TEAE)