With regards to the Phase 2 trial in patients with Relapsed / Refractory AML (Investigator Sponsored Study in Israel) and since there is nothing else Clinical to get excited about at the moment.
As per the last Quarterly , Clinical programs update :
RI-002 Phase 2 trial in patients with Relapsed / Refractory AML (Investigator Sponsored Study in Israel): The Simon 2 stage design study has progressed to the Phase 2 efficacy (expansion) stage. Three patients have completed treatment in the Phase 2 stage. Results will be reported after 9 patients have completed treatment
In the trial design announcement :
Phase 2, Expansion (Efficacy Stage)
- Up to 17 subjects will be enrolled into a Phase 2 expansion efficacy cohort using a 2-stage Simon design.
- Initially, 9 subjects will be enrolled and treated with the recommended dose of FluCloZan regimen determined in Stage 1.
- If no subject responds according to the response criteria outlined in the European Leukemia Net (ELN) guidelines, in the first 9 subjects, the study will be terminated for futility.
- If at least one subject shows a response, 8 more subjects will be enrolled and treated. If three or more of subjects treated in Stage 2 respond, the null hypothesis can be rejected.
Since the Quarterly says 3 patients were recruited , does that mean that the first patient has showed a response and therefore the recruitment continued ?
And since 3 patients have been recruited and Sheba is still continuing the trial , would that mean that the results in those 3 patients have been positive so far to warrant the trial being continued ?
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