Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With CLL

NCT05209308 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: ME-401-008
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

CLL

Keywords

Leukemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• ORR

  2 years

• Progression Free Survival

  5 years

Study Arms (2)

Cohort A

EXPERIMENTAL

Ven "low dose" + Rituximab + Zandelisib

Drug: Zandelisib; Drug: Rituximab; Drug: Venetoclax

Cohort B

EXPERIMENTAL

Ven "standard dose" + Rituximab + Zandelisib

Drug: Zandelisib; Drug: Rituximab; Drug: Venetoclax

Interventions

Zandelisib DRUG

Zandelisib taken orally for 7 days of each 28 day cycle

Also known as: ME-401

Cohort A; Cohort B

Rituximab DRUG

Rituximab IV for 6 cycles

Also known as: Rituxan, MabThera

Cohort A; Cohort B

Venetoclax DRUG

Orally - Ramp up weeks 1-5

Also known as: Venclexta

Cohort A; Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MEI Pharma, Inc.: lead
• Kyowa Kirin, Inc.: collaborator

Study Sites (4)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Stony Brook University

Stony Brook, New York, 11794, United States

Location

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Medical Oncology Associates, PS (dba Summit Cancer Centers)

Spokane, Washington, 99208, United States

Location

MeSH Terms

Conditions

Leukemia

Interventions

ME-401; Rituximab; venetoclax

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 26, 2022
• Study Start: November 22, 2022
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

US (4)