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Monoclonal Antibodies

Zandelisib for Non-Hodgkin's Lymphoma

Phase 3
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
Adequate renal and hepatic function
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year 7 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug, Zandelisib, to see if it's more effective than standard immunochemotherapy for treating relapsed or refractory FL and MZL.

Eligible Conditions
  • Non-Hodgkin's Lymphoma
  • Marginal Zone Lymphoma
  • Follicular Lymphoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your kidneys and liver are working properly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year 7 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year 7 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival
Secondary outcome measures
Complete Response Rate (CRR)
Number of Lab Abnormalities (Zandelisib When Combined With Rituximab)
Number of SAEs (Zandelisib When Combined With Rituximab)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Rituximab plus chemotherapyExperimental Treatment3 Interventions
Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles
Group II: Rituximab plus ZandelisibExperimental Treatment2 Interventions
Rituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Bendamustine
2015
Completed Phase 3
~2950
CHOP
2012
Completed Phase 3
~1460

Find a Location

Who is running the clinical trial?

MEI Pharma, Inc.Lead Sponsor
13 Previous Clinical Trials
796 Total Patients Enrolled
Kyowa Kirin, Inc.Industry Sponsor
47 Previous Clinical Trials
5,639 Total Patients Enrolled

Frequently Asked Questions

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

Are people with the target condition being recruited for this research project?

"That is correct. The information available on clinicaltrials.gov suggests that the trial is still recruiting patients. The trial was initially posted on August 13th, 2021 and was last updated on September 22nd, 2022. The study needs to recruit 534 patients from 17 different locations."

Answered by AI

Are there any other active trial sites for this medication in Canada?

"There are a total of 17 clinical sites conducting this trial; please choose the one nearest to your location to reduce travel time if you decide to enroll. The sites are located in Springfield, Long Beach, Cleveland, and 14 other cities."

Answered by AI

What are the conditions that Zandelisib has been shown to be effective against?

"Zandelisib is frequently used to treat lung cancers, including small cell lung cancer (sclc), as well as thyroiditis and polyangium."

Answered by AI

What is the efficacy of Zandelisib in treating patients?

"Zandelisib was first researched in 1993 at National Institutes of Health Clinical Center. 2190 studies have been completed to date. There are currently 1381 live trials, a large number of which are based in Springfield, Missouri."

Answered by AI

how many people are participating in this experiment?

"That is correct. The clinical trial is listed as currently recruiting patients on clinicaltrials.gov. It was first posted on 8/13/2021 and was last edited on 9/22/2022. The study is looking for 534 patients from 17 different sites."

Answered by AI

Is Zandelisib's safety and efficacy backed by the FDA?

"Zandelisib has received a score of 3 from our team at Power. This is because Zandelisib is in Phase 3 of clinical trials, suggesting that not only is there evidence of efficacy, but also that there is supportive data for safety from multiple rounds of testing."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Institut De Cancerologie Gustave Roussy
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)
2021. "Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04745832.
~22 spots leftby Apr 2025
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