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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05209308

Acronym

CORAL

Enrollment

Registered

2022-01-26

Start date

2022-11-22

Completion date

2023-03-15

Last updated

2023-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CLL

Keywords

Leukemia

Brief 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.

Interventions

DRUGZandelisib

Zandelisib taken orally for 7 days of each 28 day cycle

DRUGRituximab

Rituximab IV for 6 cycles

DRUGVenetoclax

Orally - Ramp up weeks 1-5

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

This open label study is composed of 2 cohorts: A safety run-in Cohort A followed by Cohort B. Both cohorts will follow the same dosing schedule and subjects will receive Zandelisib, however in Cohort A, VEN will be administered at a different dose then Cohort B.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
To determine the uMRD rate in PB and BM by flow cytometry	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).

Secondary

Measure	Time frame	Description
ORR	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)
Progression Free Survival	5 years	PFS will be measured as the time from first dose date until progression according the iwCLL criteria or death from any cause.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026