Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With CLL

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
MEI Pharma, Inc.
Study ID
NCT05209308
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Nov 22, 2022
Status verified
Mar 2023
Primary completion
Mar 15, 2023
Completion
Mar 15, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    Ven "low dose" + Rituximab + Zandelisib
  • Experimental: Cohort B
    Ven "standard dose" + Rituximab + Zandelisib

Primary Outcome Measure

To determine the uMRD rate in PB and BM by flow cytometry [ Time Frame: 2 year ]

Locations (4)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215-
Stony Brook UniversityStony BrookNew York11794-
OU Health Stephenson Cancer CenterOklahoma CityOklahoma73104-
Medical Oncology Associates, PS (dba Summit Cancer Centers)SpokaneWashington99208-

Find similar trials in Boston, MA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Dana Farber Cancer Institute· Boston, MAStony Brook University· Stony Brook, NYOU Health Stephenson Cancer Center· Oklahoma City, OKMedical Oncology Associates, PS (dba Summit Cancer Centers)· Spokane, WA

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