Trial Profile

A Pivotal Trial of LAM-002 in Patients with Previously Treated Follicular Lymphoma

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 06 Dec 2023

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At a glance

Drugs Apilimod dimesylate (Primary)
Indications Follicular lymphoma
Focus Registrational; Therapeutic Use
Sponsors OrphAI Therapeutics

Most Recent Events

23 Jan 2020 New trial record
16 Jan 2020 According to an AI Therapeutics media release, AI Therapeutics had a Type C meeting with the U.S. FDA to discuss the registrational program for LAM-002 in patients with previously treated follicular lymphoma. At this meeting, the company reached concurrence on the design of this pivotal trial that could support accelerated approval. The clinical data to support full approval in patients with previously treated follicular lymphoma was also discussed and a path forward was detailed.

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