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PI3Kδ inhibitor

Zandelisib (ME-401) for Non-Hodgkin's Lymphoma

Phase 2

Waitlist Available

Research Sponsored by MEI Pharma, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is looking at a new drug to treat people with lymphoma who have failed other treatments.

Eligible Conditions

Non-Hodgkin's Lymphoma
Marginal Zone Lymphoma
Follicular Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR) of ME-401 in Relapsed or Refractory FL or MZL

Secondary outcome measures

Complete Response (CR) Rate

Duration of Response (DOR)

Overall Incidence of Treatment Emergent Adverse Events (TEAEs)

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Zandelisib (ME-401) open labelExperimental Treatment1 Intervention

Subjects with relapsed/refractory FL or MZL will be administered 60 mg of ME-401 orally, once a day on an intermittent schedule (IS).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

MEI Pharma, Inc.Lead Sponsor

13 Previous Clinical Trials

709 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What evidence exists regarding the security of Zandelisib (ME-401) for human consumption?

"Based on the current clinical data, our team at Power has assigned Zandelisib (ME-401) a score of 2. This is because while it's safety profile is supported by prior research, there are no indications that this medication can influence efficacy."

Answered by AI

Is there an opportunity to join this clinical experimentation at present?

"Affirmative. According to information on the clinicaltrials.gov website, this medical trial is looking for participants and has been since June 25th 2019. As of August 17th 2022, 180 patients need to be recruited from 33 different clinics across the country."

Answered by AI

What is the geographical distribution of this trial's testing sites?

"There are presently 33 sites that are enrolling patients into this trial. Locations span from Boston and Montvale to Farmington, with a few other cities also included. To lessen travel expenses it is recommended to select the facility nearby your current residence."

Answered by AI

How many participants are accepted for this research initiative?

"To move the trial forward, 180 individuals must partake in this study and meet all specified criteria. For convenience, there are two medical centres offering participation - Dana-Farber Cancer Institute of Boston and Memorial Sloan Kettering in Montvale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)

2019. "Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03768505.