Contributions
Abstract: PB1418
Type: Publication Only
Session title: Acute myeloid leukemia - Clinical
Background
Despite progress in the treatment of AML, most patients will relapse and die from refractory disease (R/R AML). De novo and acquired MDR is a critical mechanism of resistance and limits the efficacy of anthracyclines. Liposomal Annamycin is a novel anthracycline that has been shown to overcome MDR in vitro and in vivo. In addition it has been shown both preclinically and clinically to have no cardiotoxicity.
Aims
The aims this phase I/II trial is to determine the MTD or RP2D for the phase II component to evaluate efficacy. In addition, confirmation of no cardiotoxicity is an aim.
Methods
The clinical trial is a standard 3+3 first proving safety with an expansion phase at the MTD to determine efficacy. The cohorts started at a dose of 120 mg/m2 and is now up to 240 mg/m2 with no significant toxicity. All patients have very sensitive testing for any cardiotoxocity including strain echocardiography performed in the Duke cardio-oncology lab with review in cardio-oncology at the Cleveland Clinic. Sensitive biomarkers are also done for all patients.
Results
To date, no significant toxicity has been seen. All cardiotoxicity testing including strain echocardiography and biomarkers have remained completely normal.
Conclusion
This ongoing phase I/II clinical trial is being done in Europe to confirm the previous clinical trials done in the US showing no cardiotoxicity and the ability to overcome MDR. From the previous studies, Liposomal Annamycin was shown to overcome MDR and have no cardiotoxicity.
Keyword(s):
Abstract: PB1418
Type: Publication Only
Session title: Acute myeloid leukemia - Clinical
Background
Despite progress in the treatment of AML, most patients will relapse and die from refractory disease (R/R AML). De novo and acquired MDR is a critical mechanism of resistance and limits the efficacy of anthracyclines. Liposomal Annamycin is a novel anthracycline that has been shown to overcome MDR in vitro and in vivo. In addition it has been shown both preclinically and clinically to have no cardiotoxicity.
Aims
The aims this phase I/II trial is to determine the MTD or RP2D for the phase II component to evaluate efficacy. In addition, confirmation of no cardiotoxicity is an aim.
Methods
The clinical trial is a standard 3+3 first proving safety with an expansion phase at the MTD to determine efficacy. The cohorts started at a dose of 120 mg/m2 and is now up to 240 mg/m2 with no significant toxicity. All patients have very sensitive testing for any cardiotoxocity including strain echocardiography performed in the Duke cardio-oncology lab with review in cardio-oncology at the Cleveland Clinic. Sensitive biomarkers are also done for all patients.
Results
To date, no significant toxicity has been seen. All cardiotoxicity testing including strain echocardiography and biomarkers have remained completely normal.
Conclusion
This ongoing phase I/II clinical trial is being done in Europe to confirm the previous clinical trials done in the US showing no cardiotoxicity and the ability to overcome MDR. From the previous studies, Liposomal Annamycin was shown to overcome MDR and have no cardiotoxicity.
Keyword(s):