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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05209308
Other study ID # ME-401-008
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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