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As stated near the end of your post, 9 patients will be...

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IndexInvestor

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21/06/23

16:08

Post #: 68402848
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Originally posted by M@g123: ↑

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 ?

Expand

As stated near the end of your post, 9 patients will be recruited in the first part of Stage 2 irrespective of efficacy.

All that can be concluded from Stage 2 at this stage is:
* the treatment has been safe
* not all 3 have responded. If all 3 had responded, the null hypothesis (that the treatment isn't effective) would have been rejected. That would have been announced, with the trial continuing until 9 were recruited.
Last edited by IndexInvestor: 21/06/23

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