A Study of ME-401 in Subjects With CLL/SLL, FL, and B-cell Non Hodgkin's Lymphoma
NCT ID: NCT02914938
Last Updated: 2023-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
97 participants
INTERVENTIONAL
2016-10-31
2023-03-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ME-401 Alone
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.
ME-401
60 mg
ME-401 in Combination with Rituximab
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.
ME-401
60 mg
Rituximab
IV infusion 375 mg/m2
ME-401 in Combination with Zanubrutinib
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).
ME-401
60 mg
Zanubrutinib
80 and 160 mg bid
Interventions
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ME-401
60 mg
Rituximab
IV infusion 375 mg/m2
Zanubrutinib
80 and 160 mg bid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No prior therapy with PI3Kd inhibitors
* No prior therapy with Bruton tyrosine kinase (BTK) inhibitors unless the subject was intolerant of BTK therapy or subject had disease progression
* 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
* Subject must have failed at least 1 prior systemic therapy
* QT-interval corrected according to Fridericia's formula (QTcF) ≤ 450 milliseconds (ms)
* Left ventricular ejection fraction \> 50%
* For subjects, except those with CLL, must have at least one bi-dimensionally measurable nodal lesion \>1.5 cm, as defined by Lugano Classification
* Willingness to participate in collection of pharmacokinetic samples
* A negative serum pregnancy test within 14 days of study Day 0, for females of childbearing potential
* Diagnosis of relapsed/refractory CLL SLL or FL, MZL, DLBCL and high-grade B-cell lymphoma. Subjects must meet the following criteria for relapsed or refractory disease:
* No prior therapy with PI3Kδ inhibitors
* No prior therapy with Bruton tyrosine kinase (BTK) inhibitors unless the subject was intolerant of BTK therapy or subject had disease progression
* Subjects with CLL, SLL, FL, and MZL must have a failure of at least 1 prior systemic therapy and be considered by the investigator a candidate for therapy with a rituximab-based regimen; subjects with DLBCL and high-grade B-cell lymphoma must have a failure of at least 2 prior therapies.
* QT-interval corrected according to Fridericia's formula (QTcF) ≤450 milliseconds (ms)
* Left ventricular ejection fraction \> 50%
* For subjects, except those with CLL, must have at least one bi-dimensionally measurable nodal lesion \>1.5 cm, as defined by Lugano Classification
* Willingness to participate in collection of pharmacokinetic samples
* A negative serum pregnancy test within 14 days of study Day 0 for females of childbearing potential
* Diagnosis of relapsed/refractory CLL or histologically-confirmed relapsed/refractory SLL or FL, MZL, MCL, DLBCL NOS (germinal center B-cell type or activated B-cell type)
* No prior therapy with PI3Kδ inhibitors
* No prior therapy with BTK inhibitors
* Subjects with CLL, SLL, FL, MCL, and MZL must have a failure of at least 1 prior systemic therapy, require treatment in the opinion of the investigator, and be considered by the investigator a candidate for therapy subjects with DLBCL and high-grade B-cell lymphoma must have a failure of at least 2 prior therapies
* For subjects with SLL, FL, MZL, MCL, DLBCL: At least one bi dimensionally measurable nodal lesion \> 1.5 cm in its longest diameter by CT scan or MRI
* QT-interval corrected according to Fridericia's formula (QTcF) ≤ 450 milliseconds (msec)
* Left ventricular ejection fraction \> 50% as measured by echocardiogram or multigated acquisition (MUGA) scan
* Willingness to participate in collection of pharmacokinetic samples
* For females of childbearing potential, a negative serum pregnancy test within 14 days of study Day 0
Exclusion Criteria
* Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
* Subjects who have tested positive for hepatitis B surface antigen and/or hepatitis B core antibody
* Positive for hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody
* Ongoing drug-induced pneumonitis
* History of clinically significant cardiovascular abnormalities
* History of severe bleeding disorders (ME-401 plus zanubrutinib arm only)
* Known central nervous system (CNS) hemorrhage or stroke within 6 months prior to start of study drugs (ME-401 plus zanubrutinib arm only)
18 Years
ALL
No
Sponsors
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MEI Pharma, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Arizona
Tucson, Arizona, United States
Compassionate Care
Corona, California, United States
Sylvester Comprehensive Cancer Center (Univ of Miami School of Med)
Miami, Florida, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Dana Farber
Boston, Massachusetts, United States
Memorial Sloan Kettering
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering
Middletown, New Jersey, United States
Memorial Sloan Kettering
Montvale, New Jersey, United States
Memorial Sloan Kettering
Commack, New York, United States
Memorial Sloan Kettering
Harrison, New York, United States
NYU Langone Laura & Isaac - Perlmutter Cancer Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Stony Brook
Stony Brook, New York, United States
Memorial Sloan Kettering
Uniondale, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Vanderbilt
Nashville, Tennessee, United States
University of Southwestern Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Swedish Cancer Institute
Edmonds, Washington, United States
Swedish Cancer Institute
Issaquah, Washington, United States
Swedish Cancer Center
Seattle, Washington, United States
Carbone Cancer Center
Madison, Wisconsin, United States
lstituto Oncologico della Svizzera ltaliana Ospedale Regionale Bellinzona e Valli CH
Bellinzona, , Switzerland
Countries
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References
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Pagel JM, Soumerai JD, Reddy N, Jagadeesh D, Stathis A, Asch A, Salman H, Kenkre VP, Iasonos A, Llorin-Sangalang J, Li J, Zelenetz AD. 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. Lancet Oncol. 2022 Aug;23(8):1021-1030. doi: 10.1016/S1470-2045(22)00333-3. Epub 2022 Jul 11.
Other Identifiers
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ME-401-002
Identifier Type: -
Identifier Source: org_study_id
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