The trial protocol was modified and the design sig
Post# of 153903
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Posted On: 12/31/2020 6:50:18 PM
Re: HHIGambler #70685
The trial protocol was modified and the design significantly changed after 10 patients, but it's inaccurate to say it was halted for futility, unless you mean by this that the study was not feasable under the old protocol...
Anyway, I have submitted a few questions regarding the status of the 10 patients under the old protocol and the 1 (?) patients under the new one... let's see what they have to say on Wed... they changed the wording in today's PR from "closing down" to "suspend", so I take it that it just might have been a blunder/inaccuracy.
From annual report:
Phase 2 Trial for Graft-versus-Host Disease
"This Phase 2 multi-center 100-day study with 60 patients is designed to evaluate the feasibility of the use of leronlimab as anadd-on therapy to
standard GvHD prophylaxis treatment for prevention of acute GvHD in adult patients with AML or MDS undergoing allogeneic hematopoietic stem cell
transplantation (“HST”). Enrollment of the first patient was announced in May of 2017. On October 5, 2017, we announced that the FDA had granted
orphan drug designation to leronlimab (PRO 140) for the prevention of GvHD. In March 2018, we announced that the Independent Data Monitoring
Committee (“IDMC”) for leronlimab (PRO 140) Phase 2 trial in GvHD had completed a planned interim analysis of trial data on the first 10 patients
enrolled. Following this review of data from the first 10 patients in the Phase 2 trial, we filed amendments to the protocol with the FDA. The amendments
included switching the pretreatment conditioning regimen from aggressive myeloablative (“MA”) conditioning to a reduced intensity conditioning
(“RIC”), and switching from a blinded one-for-one randomized placebo-controlled design to an open-label design under which all enrollees receive
leronlimab. The amendments also provide for a 100% increase in the dose of leronlimab, to 700 mg, to more closely mimic pre-clinical dosing. The next
review of data by the IDMC will occur following enrollment of 10 patients under the amended protocol after each patient has been dosed for 30 days. Due
to the necessary prioritization of limited capital, enrollment under the amended protocol has been temporarily delayed"
Anyway, I have submitted a few questions regarding the status of the 10 patients under the old protocol and the 1 (?) patients under the new one... let's see what they have to say on Wed... they changed the wording in today's PR from "closing down" to "suspend", so I take it that it just might have been a blunder/inaccuracy.
From annual report:
Phase 2 Trial for Graft-versus-Host Disease
"This Phase 2 multi-center 100-day study with 60 patients is designed to evaluate the feasibility of the use of leronlimab as anadd-on therapy to
standard GvHD prophylaxis treatment for prevention of acute GvHD in adult patients with AML or MDS undergoing allogeneic hematopoietic stem cell
transplantation (“HST”). Enrollment of the first patient was announced in May of 2017. On October 5, 2017, we announced that the FDA had granted
orphan drug designation to leronlimab (PRO 140) for the prevention of GvHD. In March 2018, we announced that the Independent Data Monitoring
Committee (“IDMC”) for leronlimab (PRO 140) Phase 2 trial in GvHD had completed a planned interim analysis of trial data on the first 10 patients
enrolled. Following this review of data from the first 10 patients in the Phase 2 trial, we filed amendments to the protocol with the FDA. The amendments
included switching the pretreatment conditioning regimen from aggressive myeloablative (“MA”) conditioning to a reduced intensity conditioning
(“RIC”), and switching from a blinded one-for-one randomized placebo-controlled design to an open-label design under which all enrollees receive
leronlimab. The amendments also provide for a 100% increase in the dose of leronlimab, to 700 mg, to more closely mimic pre-clinical dosing. The next
review of data by the IDMC will occur following enrollment of 10 patients under the amended protocol after each patient has been dosed for 30 days. Due
to the necessary prioritization of limited capital, enrollment under the amended protocol has been temporarily delayed"
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