Zandelisib (ME-401) for Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Lymphoma+5 More
Zandelisib (ME-401) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is looking at a new drug to treat people with lymphoma who have failed other treatments.

Eligible Conditions
  • Lymphoma
  • Non-Hodgkin's Lymphoma (NHL)
  • Lymphoma, Follicular

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 2 years

2 years
Complete response (CR) rate
Duration of response (DOR)
Objective response rate (ORR) of ME-401 in relapsed or refractory FL or MZL based on the Independent Review Committee assessment
Overall Survival
Overall incidence of treatment emergent adverse events (TEAEs)
Progression-free survival (PFS)
6 months
PK of ME-401

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Zandelisib (ME-401) open label
1 of 1

Experimental Treatment

180 Total Participants · 1 Treatment Group

Primary Treatment: Zandelisib (ME-401) · No Placebo Group · Phase 2

Zandelisib (ME-401) open label
Drug
Experimental Group · 1 Intervention: Zandelisib (ME-401) · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

MEI Pharma, Inc.Lead Sponsor
12 Previous Clinical Trials
1,277 Total Patients Enrolled
4 Trials studying Lymphoma
845 Patients Enrolled for Lymphoma

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a QT interval corrected for age of at least 450 milliseconds (msec).
You have at least one bi-dimensionally measurable nodal lesion > 1.5 cm in its longest diameter by computed tomography (CT) scan as defined by the Lugano Classification.
Adequate hematologic, renal and hepatic parameters at screening unless abnormal values are due to FL per Investigator assessment.
You have a left ventricular ejection fraction (LVEF) of 45% or more.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: November 9th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.