IRB #

STUDY00019674

Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Phase 2 Study of ME-401 in Subjects with Follicular Lymphoma After Failure of Two or More Prior Systemic Therapies

Principal Investigator

Craig Okada

Study Purpose

The purpose of this study is to learn how well an investigational drug called ME-401 (the study drug) works on controlling your lymphoma, to learn about the safety of the drug, and to compare the safety of 2 different schedules of administering the study drug. The 2 dosing groups will be assigned by randomization (by chance, like the toss of a coin).
- Group A: study drug 60 mg once daily on the continuous schedule (CS) in 28-day cycles
- Group B: study drug 60 mg once daily on the intermittent schedule (IS) in 28-day cycles with 7 days of active study drug and 21 days of placebo (a placebo is an inactive material that looks like the study drug but does not contain any active study drug)

Medical Condition(s)

Relapsed or refractory follicular lymphoma

Eligibility Criteria

- Men and women at least 18 years of age who have been diagnosed with follicular lymphoma
- You must have previously received 2 or more systemic therapies for your cancer, and your cancer has either returned after the most recent treatment (relapsed), or not responded to your most recent treatment (refractory)

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

You may be in this study for about 2 years, and you will need to come to the study center at least 16 times over this period. After you have finished taking the study drug, the investigator will watch you for side effects and follow your condition through clinic visits or follow-up phone calls every 3 months until the study has concluded.

Minors Included

No

Contact

Clinical Trials Information Line
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

MEI Pharma, Inc.

Recruitment End

01/01/2022

Compensation Provided

No


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