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
Nashville, Tennessee 37212
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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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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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