Clinical trial NCT05209308: Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With CLL
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: CLL
Keywords: Leukemia
Lead sponsor: MEI Pharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Kyowa Kirin, Inc.
First posted: 2022-01-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: To determine the uMRD rate in PB and BM by flow cytometry
timeFrame: 2 year
Secondary outcomes:
measure: ORR
timeFrame: 2 years
measure: Progression Free Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Oklahoma City
country: United States
facility: OU Health Stephenson Cancer Center
state: Oklahoma
city: Spokane
country: United States
facility: Medical Oncology Associates, PS (dba Summit Cancer Centers)
state: Washington
Study officials:
References: