4 new sites added to MDS study

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biopearl123
Posts: 1665
Joined: Fri Jul 20, 2018 5:13 pm

4 new sites added to MDS study

Post by biopearl123 » Thu Oct 22, 2020 10:29 pm

Study continues to ramp up. Several sites still "active but not recruiting" but presumably will be in the near future. At this point each site only needs to enroll about 2 patients to get to the finish line. Since we have not yet received confirmation about reaching the 50 % enrollment mark, I would think we have to be there soon. bp

CKTC
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Re: 4 new sites added to MDS study

Post by CKTC » Fri Oct 23, 2020 7:36 pm

If they truly haven’t gotten to the half-way point yet, this is going to take forever to enroll. At this rate, they could fully enroll the new MF trial before the MDS trial.

BTW, the new MF trial is interesting. They’re allowing a crossover from the Comparator Arm to the Imtetelstat Arm upon disease progression. And the definition of Refractory to JAK-inhibitor treatment is really strict.
https://clinicaltrials.gov/ct2/show/NCT ... w=2&rank=2

biopearl123
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Joined: Fri Jul 20, 2018 5:13 pm

Re: 4 new sites added to MDS study

Post by biopearl123 » Fri Oct 23, 2020 10:02 pm

CKTC, I missed the crossover allowance, thanks for pointing that out. Finally a study design that might not actually have to go to completion. bp

biopearl123
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Joined: Fri Jul 20, 2018 5:13 pm

Re: 4 new sites added to MDS study

Post by biopearl123 » Fri Oct 23, 2020 10:29 pm

CKTC, was thinking about your comment re crossover. Clearly allowing crossover is morally correct. But since mortality is the primary endpoint and not some other (admittedly more nebulous endpoint like disease progression), won’t allowing crossover murkify the mortality end point, prolong the study (if not nullifying it) and destroy the control arm value? TIA for your thoughts. bp

biopearl123
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Joined: Fri Jul 20, 2018 5:13 pm

Re: 4 new sites added to MDS study

Post by biopearl123 » Sat Oct 24, 2020 12:18 am

Ah, bet crossover allowed only after (and if) early look is significant at which point primary end point would be proven but study would continue. At that point provisional approval could be requested.

CKTC
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Joined: Sun May 31, 2020 4:26 am

Re: 4 new sites added to MDS study

Post by CKTC » Sat Oct 24, 2020 4:07 pm

Here's the exact wording:

"Participants who meet progressive disease criteria and discontinue BAT, may crossover to receive imetelstat treatment after sponsor's approval."

Allowing a crossover is more appealing, both ethically and from a recruitment standpoint. But it creates challenges in trial results interpretation because of confounding. How they plan to allow for crossover would be a good question for Dr. Scarlett.

Zhears
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Joined: Mon Oct 08, 2018 12:19 pm

Re: 4 new sites added to MDS study

Post by Zhears » Sun Oct 25, 2020 12:06 pm

Crossover would only be allowed after they have overwhelming results and it would be unethical to leave people on a placebo. Which would basically mean that the drug is approved and they are going through the formalities.

I doubt this would be something we would get much information from scarlet on. Unless its results at something like ASH...we can hope.

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