Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With CLL

CLL Clinical Trial

— CORAL  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05209308
• Other study ID #: ME-401-008
• Status: Withdrawn
• Phase: Phase 2
• Start date: November 22, 2022
• Est. completion date: March 15, 2023

Study information

• Verified date: March 2023
• Source: MEI Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CLL

Intervention

Drug:
• Zandelisib
Zandelisib taken orally for 7 days of each 28 day cycle
• Rituximab
Rituximab IV for 6 cycles
• Venetoclax
Orally - Ramp up weeks 1-5

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	OU Health Stephenson Cancer Center	Oklahoma City	Oklahoma
United States	Medical Oncology Associates, PS (dba Summit Cancer Centers)	Spokane	Washington
United States	Stony Brook University	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
MEI Pharma, Inc.	Kyowa Kirin, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the uMRD rate in PB and BM by flow cytometry	measured by 8-color flow cytometry with a quantitative lower limit of detection of at least 10-4 (1 in 10,000 cells).	2 year
Secondary	ORR	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)	2 years
Secondary	Progression Free Survival	PFS will be measured as the time from first dose date until progression according the iwCLL criteria or death from any cause.	5 years