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

  • STATUS
    Recruiting
  • End date
    Mar 19, 2026
  • participants needed
    42
  • sponsor
    MEI Pharma, Inc.
Updated on 4 October 2022

Summary

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

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.

Details
Condition CLL
Treatment Rituximab, venetoclax, Zandelisib
Clinical Study IdentifierNCT05209308
SponsorMEI Pharma, Inc.
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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