Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With CLL (CORAL)

March 14, 2023 updated by: MEI Pharma, Inc.

A Phase 2 Single-Arm, Open-Label Study to Assess the Safety and Efficacy of Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia - The CORAL Study

A Phase 2 study of Zandelisib with Venetoclax (VEN) and Rituximab (R) in subjects with Relapsed/Refractory CLL.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This is an open label Phase 2 clinical study of Zandelisib with Venetoclax (VEN) and Rituximab (R) in subjects with R/R CLL.

VEN and R will be administered per standard of care.

Subjects must have histologically confirmed relapsed/refractory CLL and received ≥1 lines of prior therapy

A total 42 subjects will be enrolled and treated with zandelisib in combination with VEN + R.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • New York
      • Stony Brook, New York, United States, 11794
        • Stony Brook University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • OU Health Stephenson Cancer Center
    • Washington
      • Spokane, Washington, United States, 99208
        • Medical Oncology Associates, PS (dba Summit Cancer Centers)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males or females ≥18 years
  • Histologically confirmed relapsed/refractory CLL who received ≥1 lines of prior therapy
  • At least one bi-dimensionally measurable nodal lesion >1.5 cm
  • Adequate renal, hepatic function
  • Adequate hematologic parameters at screening

Exclusion Criteria:

  • Subjects who relapsed or progressed on BCL-2 inhibitor
  • Relapsed within 2 years of discontinuation of prior PI3K inhibitor (PI3Ki) therapy or disease progression on PI3Ki therapy
  • History or currently active HBV, HCV; any uncontrolled active infection, HIV infection; HIV-related lymphoma
  • History of Richter's transformation or prolymphocytic leukemia
  • Known allergies to both xanthine oxidase inhibitors and rasburicase, or any excipients of the drug products
  • Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure
  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A
Ven "low dose" + Rituximab + Zandelisib
Drug: Zandelisib
Zandelisib taken orally for 7 days of each 28 day cycle
Other Names:
  • ME-401
Drug: Rituximab
Rituximab IV for 6 cycles
Other Names:
  • Rituxan
  • MabThera
Drug: Venetoclax
Orally - Ramp up weeks 1-5
Other Names:
  • Venclexta
Experimental: Cohort B
Ven "standard dose" + Rituximab + Zandelisib
Drug: Zandelisib
Zandelisib taken orally for 7 days of each 28 day cycle
Other Names:
  • ME-401
Drug: Rituximab
Rituximab IV for 6 cycles
Other Names:
  • Rituxan
  • MabThera
Drug: Venetoclax
Orally - Ramp up weeks 1-5
Other Names:
  • Venclexta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the uMRD rate in PB and BM by flow cytometry
Time Frame: 2 year
measured by 8-color flow cytometry with a quantitative lower limit of detection of at least 10-4 (1 in 10,000 cells).
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 2 years
The ORR will be measured by the proportion of subjects having achieved a CR/CRi (CR with incomplete recovery in BM) or partial response (PR) according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines (2018)
2 years
Progression Free Survival
Time Frame: 5 years
PFS will be measured as the time from first dose date until progression according the iwCLL criteria or death from any cause.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MEI Pharma, Inc.

Collaborators

Kyowa Kirin, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2022

Primary Completion (Actual)

March 15, 2023

Study Completion (Actual)

March 15, 2023

Study Registration Dates

First Submitted

January 12, 2022

First Submitted That Met QC Criteria

January 12, 2022

First Posted (Actual)

January 26, 2022

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ME-401-008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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