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Monoclonal Antibodies

Zandelisib for Chronic Lymphocytic Leukemia (CORAL Trial)

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 5 years

Awards & highlights

CORAL Trial Summary

This trial is testing a new drug combination to treat CLL.

CORAL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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

To determine the uMRD rate in PB and BM by flow cytometry

Secondary outcome measures

ORR

Progression Free Survival

CORAL Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort BExperimental Treatment3 Interventions

Ven "standard dose" + Rituximab + Zandelisib

Group II: Cohort AExperimental Treatment3 Interventions

Ven "low dose" + Rituximab + Zandelisib

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~1990

Rituximab

1999

Completed Phase 4

~1880

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

878 Total Patients Enrolled

Kyowa Kirin, Inc.Industry Sponsor

47 Previous Clinical Trials

5,721 Total Patients Enrolled

Frequently Asked Questions

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

How many participants are joining this research initiative?

"In order to successfully launch this trial, 42 qualified patients must enroll. Prospective participants can access the clinical research from Medical Oncology Associates in Spokane or Stony Brook University in New york."

Answered by AI

What is the number of medical facilities participating in this research project?

"This medical study is recruiting patients from Medical Oncology Associates, PS (dba Summit Cancer Centers) in Spokane, Stony Brook University of Stony Brook, and OU Health Stephenson Cancer Center of Oklahoma City. Additionally, there are 4 other sites open for enrollment."

Answered by AI

Is there availability for participants in this trial?

"Affirmative. Clinicaltrials.gov's records demonstrate that this clinical trial is currently recruiting patients, beginning from the 1st of November 2022 and last updated on 3rd of November 2022. 42 participants need to be enlisted from 4 distinct medical centres."

Answered by AI

Has the FDA sanctioned Zandelisib as an acceptable treatment option?

"Considering there is evidence for Zandelisib's safety but a lack of data to confirm its efficacy, our team at Power assess the risk level associated with it as a 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With CLL

2022. "Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With CLL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05209308.