GATE1: A Multicenter Phase II Study of Pirtobrutinib, Rituximab and Venetoclax Combination Therapy for Patients With Previously Untreated Mantle Cell Lymphoma

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06522386
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Pirtobrutinib — DRUG
    Given by mouth
  • Rituximab — DRUG
    Given by vein (IV)
  • Venetoclax — DRUG
    Given by mouth

Study Details

Primary Objectives: To estimate the percent of participants who achieve a best response of complete response by the end of the PRV combination therapy in the induction therapy phase in patients with previously untreated MCL.

Key Dates

Start date
Jan 30, 2025
Status verified
Apr 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2029

Study Design

Enrollment
50 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pirtobrutinib, Rituximab and Venetoclax combination

Primary Outcome Measure

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: Through study completion; an average of 1 year. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55902-
MD Anderson Cancer CenterHoustonTexas77030-

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Mayo Clinic in Rochester· Rochester, MNMD Anderson Cancer Center· Houston, TX

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