Two-Arm, Phase 1b, Open-Label, Dose Escalation Study of ME-401 in Subjects With Relapsed/Refractory CLL, SLL, or FL and an Open-Label Study of ME-401 With Rituximab in Subjects With Relapsed/Refractory CLL/SLL or B-cell NHL

Trial Profile

Two-Arm, Phase 1b, Open-Label, Dose Escalation Study of ME-401 in Subjects With Relapsed/Refractory CLL, SLL, or FL and an Open-Label Study of ME-401 With Rituximab in Subjects With Relapsed/Refractory CLL/SLL or B-cell NHL

Recruiting
Phase of Trial: Phase I

Latest Information Update: 27 Dec 2017

At a glance

  • Drugs ME 401 (Primary)
  • Indications Chronic lymphocytic leukaemia; Diffuse large B cell lymphoma; Follicular lymphoma; Marginal-zone-B-cell-lymphoma; Non-Hodgkin's lymphoma
  • Focus Adverse reactions; Proof of concept
  • Sponsors MEI Pharma
  • Most Recent Events

    • 18 Dec 2017 Planned number of patients changed from 84 to 156.
    • 08 Nov 2017 According to an MEI Pharma media release, the company expects results to be presented at a scientific meeting in the first half of 2018.
    • 31 May 2017 According to an MEI Pharma media release, an independent Safety Review Committee has completed its pre-specified review of the first cohort of six evaluable patients and declared a minimum biologically effective dose (mBED) for ME-401 at the starting dose of 60 mg and recommended escalation to a 120 mg dose cohort. Full data will be submitted for presentation at an upcoming scientific meeting.
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