ME-401 for Lymphoma, B-Cell
Phase-Based Progress Estimates
Effectiveness
Safety
Lymphoma, B-Cell+13 More
ME-401 - DrugEligibility
18+
All Sexes
What conditions do you have?
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Eligibility
18+
All Sexes
What conditions do you have?
Select
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
- Lymphoma, B-Cell
- Mantle Cell Lymphoma (MCL)
- Small Lymphocytic Lymphoma
- Diffuse Large B-cell Lymphoma (DLBCL)
- B-Cell Lymphomas
- Lymphoma, Follicular
- Lymphoma, Non-Hodgkin
- Chronic Lymphocytic Leukemia (CLL)
Treatment Effectiveness
Study Objectives
7 Primary · 10 Secondary · Reporting Duration: 2 years
1 year
Determine the MTD of ME-401 plus zanubrutinib
Evaluate the safety and tolerability of ME-401 plus rituximab
Evaluate the safety and tolerability of ME-401 plus zanubrutinib
Maximally Tolerated Dose (MTD) of ME-401 alone
Minimum Biologically Effective Dose (mBED) of ME-401 alone
Safety profile of ME-401 alone
2 years
Efficacy of ME-401 alone as assessed by (OR)
Efficacy of ME-401 with rituximab
Efficacy of ME-401 with zanubrutinib
Evaluate the (AUC) PK of ME-401 alone
Evaluate the PK (AUC) of ME-401 in combination with zanubrutinib
Pyruvate Kinase
Evaluate the PK (Cmax) of ME-401 alone
Evaluate the PK (Cmax) of ME-401 in combination with zanubrutinib
Evaluate the PK (Cmax) of ME-401 with rituximab
Day 56
Determine the DLTs of ME-401 plus zanubrutinib
Dose Limiting Toxicities (DLTs) of ME-401 alone
Trial Safety
Trial Design
3 Treatment Groups
ME-401 Alone
1 of 3
ME-401 in Combination with Rituximab
1 of 3
ME-401 in Combination with Zanubrutinib
1 of 3
Experimental Treatment
177 Total Participants · 3 Treatment Groups
Primary Treatment: ME-401 · No Placebo Group · Phase 1
ME-401 Alone
Drug
Experimental Group · 1 Intervention: ME-401 · Intervention Types: DrugME-401 in Combination with RituximabExperimental Group · 2 Interventions: ME-401, Rituximab · Intervention Types: Drug, Drug
ME-401 in Combination with ZanubrutinibExperimental Group · 2 Interventions: ME-401, Zanubrutinib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zanubrutinib
FDA approved
Rituximab
FDA approved
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
1,280 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have relapsed/refractory CLL or SLL or FL.
You have no prior therapy with Bruton tyrosine kinase (BTK) inhibitors.
Subjects with CLL/SLL must have prior treatment with BTK inhibitor and must have had progression or recurrence while on treatment of within 12 mos from BTK treatment.
You have a QT interval corrected for age of 18 years or older.
You have a left ventricular ejection fraction of greater than 50%.
You must have at least one bi-dimensionally measurable nodal lesion >1.
You are a female of childbearing potential.
About The Reviewer
Michael Gill - B. Sc.
First Published: October 10th, 2021
Last Reviewed: November 27th, 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.
References
- Pagel, John M, Jacob D Soumerai, Nishitha Reddy, Deepa Jagadeesh, Anastasios Stathis, Adam Asch, Huda Salman, et al.. 2022. “Zandelisib with Continuous or Intermittent Dosing as Monotherapy or in Combination with Rituximab in Patients with Relapsed or Refractory B-cell Malignancy: A Multicentre, First-in-patient, Dose-escalation and Dose-expansion, Phase 1b Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(22)00333-3.
- Pagel, John M, Jacob D Soumerai, Nishitha Reddy, Deepa Jagadeesh, Anastasios Stathis, Adam Asch, Huda Salman, et al.. 2022. “Zandelisib with Continuous or Intermittent Dosing as Monotherapy or in Combination with Rituximab in Patients with Relapsed or Refractory B-cell Malignancy: A Multicentre, First-in-patient, Dose-escalation and Dose-expansion, Phase 1b Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(22)00333-3.
- 2016. "A Study of ME-401 in Subjects With CLL/SLL, FL, and B-cell Non Hodgkin's Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02914938.
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