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PI3K inhibitor

ME-401 for Chronic Lymphocytic Leukemia

Phase 1
Waitlist Available
Research Sponsored by MEI Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will study the safety and efficacy of the drug ME-401 in patients with relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma, or follicular lymphoma.

Eligible Conditions
  • Chronic Lymphocytic Leukemia
  • Non-Hodgkin's Lymphoma
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
  • Lymphoma
  • Follicular Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the DLTs of ME-401 plus zanubrutinib
Determine the MTD of ME-401 plus zanubrutinib
Dose Limiting Toxicities (DLTs) of ME-401 alone
+4 more
Secondary outcome measures
Efficacy of ME-401 alone as assessed by (OR)
Efficacy of ME-401 with rituximab
Efficacy of ME-401 with zanubrutinib
+7 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: ME-401 in Combination with ZanubrutinibExperimental Treatment2 Interventions
The third arm is an open label study evaluating the safety, efficacy, MTD, DLT and pharmacokinetics of ME-401 in combination with zanubrutinib in subjects with various B-cell malignancies. This arm will include 2 stages: a safety evaluation stage (cohort of 6-12 subjects) and a disease-specific expansion cohort stage (up to 74 subjects).
Group II: ME-401 in Combination with RituximabExperimental Treatment2 Interventions
The second arm is an open label study to evaluate the safety, efficacy, and pharmacokinetics of ME-401 in combination with rituximab in subjects with various B-cell malignancies. There are two planned cohorts which may enroll up to 30 subjects.
Group III: ME-401 AloneExperimental Treatment1 Intervention
This arm is an open-label, dose escalation study to determine the safety, efficacy and pharmacokinetics of ME-401 along with the mBED, MTD, and DLTs. There are 4 planned cohorts which may enroll up to 61 subjects.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zanubrutinib
2017
Completed Phase 3
~1940
Rituximab
1999
Completed Phase 4
~1880

Find a Location

Who is running the clinical trial?

MEI Pharma, Inc.Lead Sponsor
13 Previous Clinical Trials
781 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any participation opportunities in this clinical trial?

"According to official documentation from clinicaltrials.gov, this particular trial is no longer seeking patients as of August 17th 2022. Although the study began recruiting on October 1st 2016, there are currently 2362 other medical trials actively searching for volunteers in lieu of this one."

Answered by AI

What objectives is this clinical trial attempting to attain?

"This clinical trial's primary aim is to assess the safety and tolerance of ME-401 when combined with zanubrutinib, evaluated over 56 days. Secondary objectives include examining the peak plasma concentrations (Cmax) of ME-401 alone, assessing any treatment related adverse events via CTCAE v4.0, as well as calculating the Area Under the Concentration time curve (AUC)."

Answered by AI

How many participants are being monitored in this clinical trial?

"At the moment, this clinical study is not seeking new candidates. The trial was posted on October 1st 2016 and last revised August 17th 2022. For those looking for alternative experiments to join, 1936 studies recruiting lymphoma patients using b-cells are available, as well as 426 trials actively enrolling participants in ME-401 research."

Answered by AI

Has ME-401 been tested in any other research initiatives?

"In 1993, ME-401 had its debut at the National Institutes of Health Clinical Centre. Since then 823 trials have been concluded and 426 are currently underway. Many of these studies take place in Oklahoma City, OK."

Answered by AI

How many medical institutions are currently participating in this trial?

"At present, 22 medical facilities are enrolling patients for this research. The list of locations includes Oklahoma City, Cleveland and Nashville, plus 19 other sites across the nation; make sure to select a site close by in order to reduce travelling expenses if you participate."

Answered by AI

Has the U.S. Food and Drug Administration sanctioned ME-401?

"The safety of ME-401 is rated 1 out of 3 due to the lack of data in regards to its efficacy and limited evidence regarding its security."

Answered by AI

What ailments is ME-401 used to treat most frequently?

"ME-401 is a promising treatment for conditions such as relapsed marginal zone lymphoma, diffuse large b-cell lymphoma (dlbcl), and other forms of B cell lymphomas or polyangiitis."

Answered by AI
Recent research and studies
~11 spots leftby Apr 2025