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

MEI Pharma

Status and phase: Withdrawn; Phase 2

Conditions: CLL

Treatments: Drug: Rituximab; Drug: Zandelisib; Drug: Venetoclax

Study type: Interventional

Funder types: Industry

Identifiers

NCT05209308

ME-401-008

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Cohort A

Experimental group

Description:

Ven "low dose" + Rituximab + Zandelisib

Treatment:

Drug: Venetoclax

Drug: Zandelisib

Drug: Rituximab

Cohort B

Experimental group

Description:

Ven "standard dose" + Rituximab + Zandelisib

Treatment:

Drug: Venetoclax

Drug: Zandelisib

Drug: Rituximab