A Phase 1 interventional study of ME-401 and Rituximab in Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL) and Follicular Lymphoma (FL), sponsored by MEI Pharma, Inc.. Terminated at 24 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-09.
Sponsored by MEI Pharma, Inc. · Phase 1, Interventional, and Treatment
A Three-Arm Study of ME-401 in Subjects with Relapsed/Refractory CLL/SLL or FL, of ME-401 in Combination with Rituximab in Subjects with Relapsed/Refractory CLL/SLL or B-cell NHL, and of ME-401 in Combination with Zanubrutinib in Subjects with Relapsed/Refractory CLL/SLL or B-cell NHL
This is a three-arm study of ME-401 alone, of ME-401 in combination with rituximab, and of ME-401 in combination with zanubrutinib in subjects with relapsed/refractory CLL/SLL or B cell NHL. The 3 arms of the study will be conducted in parallel, with subject allocation to ME-401 alone, ME-401 plus rituximab, or ME-401 plus zanubrutinib based on disease type and availability of an open enrollment slot.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 97 is above the median of 40 across 4,509 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →MEI Pharma, Inc. is the lead sponsor of 13 studies on the registry; none are open to participants now.
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Inclusion Criteria ME-401 in Combination with Rituximab
Inclusion Criteria ME-401 in Combination with Zanubrutinib
Exclusion Criteria:
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.
Drug: ME-401
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.
Drug: ME-401 · Drug: Rituximab
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).
Drug: ME-401 · Drug: Zanubrutinib
60 mg
IV infusion 375 mg/m2
Also known as: Rituxan
80 and 160 mg bid
Minimum Biologically Effective Dose (mBED) of ME-401 alone
The mBED will be defined as the dose that is safe and that achieves an objective response rate that is not less than 30%.
Time frame: 1 year
Maximally Tolerated Dose (MTD) of ME-401 alone
The MTD will be determined as the maximum dose that is safe. DLT rate closest to .25 and not to exceed 2 DLTs in 6 subjects
Time frame: 1 year
Dose Limiting Toxicities (DLTs) of ME-401 alone
DLTs will be measured by the number of treatment related AEs that occur within the first 56 days of ME-401 administration, is considered clinically significant by the P.I. and occurs in the presence of supportive care
Time frame: within the first 56 days
Evaluate the safety and tolerability of ME-401 plus rituximab
Safety and tolerability will be measured by the number of treatment related AEs
Time frame: 1 year
Determine the MTD of ME-401 plus zanubrutinib
The MTD of ME-401 is defined as the dose level with a DLT rate closest to 0.25.
Time frame: 1 year
Determine the DLTs of ME-401 plus zanubrutinib
DLTs will be measured by the number of treatment related AEs that occur within the first 56 days of ME-401 plus zanubrutinib
Time frame: within the first 56 days
Evaluate the safety and tolerability of ME-401 plus zanubrutinib
Safety and tolerability will be measured by the number of treatment related AEs
Time frame: 1 year
Safety profile of ME-401 alone
Safety profile will be measured by number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 1 year
Efficacy of ME-401 alone as assessed by (OR)
The efficacy of ME-401 alone will be assessed by the overall response (OR) of subjects which is calculated as the percent of subjects achieving complete response (CR), minimal disease negativity (MRD), duration of response (DOR) and progression free survival (PFS).
Time frame: 2 years
Evaluate the (AUC) PK of ME-401 alone
Determined by the Area Under the Concentration time curve (AUC)
Time frame: 2 years
Evaluate the PK (Cmax) of ME-401 alone
Determined by Peak Plasma Concentration (Cmax)
Time frame: 2 years
Efficacy of ME-401 with rituximab
The efficacy of ME-401 with Rituximab will be determined by the overall response (OR) of subjects calculated as the percent of subjects achieving a complete remission (CR), duration of response (DOR) or Progression Free survival (PFS) according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL)
Time frame: 2 years
Evaluate the PK (AUC) of ME-401 with rituximab
Determined by the Area Under the Concentration time curve (AUC)
Time frame: 2 years
Evaluate the PK (Cmax) of ME-401 with rituximab
Determined by Peak Plasma Concentration (Cmax)
Time frame: 2 years
Efficacy of ME-401 with zanubrutinib
The efficacy of ME-401 with zanubrutinib will be assessed by the overall response (OR) of subjects calculated as the percent of subjects achieving a complete remission (CR), Duration of response (DOR) and progression free survival (PFS)
Time frame: 2 years
Evaluate the PK (AUC) of ME-401 in combination with zanubrutinib
Determined by the Area Under the Concentration time curve (AUC)
Time frame: 2 years
Evaluate the PK (Cmax) of ME-401 in combination with zanubrutinib
Determined by Peak Plasma Concentration (Cmax)
Time frame: 2 years
This study is terminated, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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MEI Pharma, Inc.