Phase II Study of Combined Pirtobrutinib, Venetoclax and Obinutuzumab (PVO) Time-limited Treatment for Patients With Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL).

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06967610
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Pirtobrutinib — DRUG
    Given PO 200mg daily
  • Venetoclax — DRUG
    Given PO daily
  • Obinutuzumab — DRUG
    Given IV 100mg day 1, 900 mg day 2, 100mg days 8, 15

Study Details

To learn if the drug combination pirtobrutinib, venetoclax, and obinutuzumab can help to control relapsed CLL/SLL.

Key Dates

Start date
Jul 15, 2025
Status verified
Nov 2025
Primary completion
Jun 1, 2031
Completion
Jun 1, 2033

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: V-Exposed
    Venetoclax Exposed: Treatment with Pirtobrutinib+Venetoclax+Obinutuzumab Q4W
  • Experimental: V-Naive
    Venetoclax Naive: Treatment with Pirtobrutinib+Venetoclax+Obinutuzumab Q4W

Primary Outcome Measure

Safety and adverse events [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Alessandra Ferrajoli, MD
713-792-2063
Alessandra Ferrajoli, MD (PRINCIPAL_INVESTIGATOR)

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