A Study of ME-401 in Subjects With CLL/SLL, FL, and B-cell Non Hodgkin's Lymphoma



Status:Recruiting
Conditions:Blood Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/30/2018
Start Date:October 2016
End Date:July 2020
Contact:Lisa McColley
Email:lmccolley@clinipace.com
Phone:402-238-2615

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A Two-Arm, Phase 1b, Open-Label, Dose Escalation Study of ME-401 in Subjects With Relapsed/Refractory CLL, SLL, or FL and an Open-Label Study of ME-401 in Combination With Rituximab in Subjects With Relapsed/Refractory CLL/SLL or B-cell NHL

This is a two-arm, Phase 1b, open-label, dose escalation study of ME-401 alone and an
open-label study of ME-401 in combination with rituximab in patients with relapsed/refractory
B-cell malignancies.

This is a two-arm, Phase 1b, open-label, dose escalation study of ME-401 alone and an
open-label study of ME-401 in combination with rituximab in patients with relapsed/refractory
B-cell malignancies. The two arms of the study will be conducted in parallel, with subject
allocation to ME-401 alone or ME-401 plus rituximab based on disease type and availability of
an open enrollment slot.

Inclusion Criteria MEI-401 Alone:

- Diagnosis of relapsed/refractory CLL and/or relapsed/refractory SLL or FL

- No prior therapy with PI3Kd inhibitors

- No prior therapy with Bruton tyrosine kinase (BTK) inhibitors unless the subject was
intolerant of BTK therapy

- 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

Inclusion Criteria ME-401 in Combination with Rituximab

- 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:

1. Relapsed disease: a subject who previously achieved a CR or PR, but demonstrated
disease progression after a response duration of >6 months

2. Refractory disease: a subject who demonstrated disease progression within 6
months of most recent therapy

- No prior therapy with PI3Kδ inhibitors

- No prior therapy with Bruton tyrosine kinase (BTK) inhibitors unless the subject was
intolerant of BTK therapy

- 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

Exclusion Criteria:

- Known histological transformation from CLL to an aggressive lymphoma

- 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
We found this trial at
10
sites
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Bellinzona,
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55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Massachusetts General Hospital Cancer Center An integral part of one of the world
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Boston, MA
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260 East Ontario Avenue
Corona, California 92708
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Corona, CA
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600 Highland Avenue
Madison, Wisconsin 53792
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Madison, WI
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Nashville, Tennessee 37212
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Nashville, TN
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Seattle, Washington 98122
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Seattle, WA
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100 Nicolls Road
Stony Brook, New York 11794
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Stony Brook, NY
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