CORAL: Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With CLL

Sponsor
MEI Pharma, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05209308
Collaborator
Kyowa Kirin (Other)
42
Enrollment
2
Arms
48
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Feb 1, 2026

Arms and Interventions

ArmIntervention/Treatment
Experimental: Cohort A

Ven "low dose" + Rituximab + Zandelisib

Drug: Zandelisib
Zandelisib taken orally for 7 days of each 28 day cycle
Other Names:
  • ME-401
  • Drug: Rituximab
    Rituximab IV for 6 cycles
    Other Names:
  • Rituxan
  • MabThera
  • Drug: Venetoclax
    Orally - Ramp up weeks 1-5
    Other Names:
  • Venclexta
  • Experimental: Cohort B

    Ven "standard dose" + Rituximab + Zandelisib

    Drug: Zandelisib
    Zandelisib taken orally for 7 days of each 28 day cycle
    Other Names:
  • ME-401
  • Drug: Rituximab
    Rituximab IV for 6 cycles
    Other Names:
  • Rituxan
  • MabThera
  • Drug: Venetoclax
    Orally - Ramp up weeks 1-5
    Other Names:
  • Venclexta
  • Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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)

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • MEI Pharma, Inc.
    • Kyowa Kirin

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MEI Pharma, Inc.
    ClinicalTrials.gov Identifier:
    NCT05209308
    Other Study ID Numbers:
    • ME-401-008
    First Posted:
    Jan 26, 2022
    Last Update Posted:
    Feb 11, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by MEI Pharma, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 11, 2022