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WITHDRAWNPHASE2

Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With CLL

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

NCT05209308•MEI Pharma, Inc.

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (4)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Stony Brook University

Stony Brook, New York, United States

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Medical Oncology Associates, PS (dba Summit Cancer Centers)

Spokane, Washington, United States

Key Dates

Start Date

November 22, 2022

Primary Completion Date

March 15, 2023

Completion Date

March 15, 2023

Last Updated

March 16, 2023

Conditions

CLL

Interventions

Zandelisib

DRUG

Rituximab

DRUG

Venetoclax

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With CLL

Inclusion Criteria

Exclusion Criteria

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms

A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies

Registry of the German CLL Study Group

Zanubrutinib and Venetoclax in CLL (ZANU-VEN)

Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma