Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05529069
Phase
PHASE2
Status
Recruiting
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Conditions

  • Hematologic Malignancy
  • Mantle Cell Lymphoma
  • Non Hodgkin Lymphoma

Eligibility Criteria

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

Interventions

  • Pirtobrutinib — DRUG
    Given by PO
  • Venetoclax — DRUG
    Given by PO

Study Details

To learn if the combination of pirtobrutinib (also called LOXO-305) and venetoclax can help to control mantle cell lymphoma (MCL) that is relapsed (has come back) or refractory (has not responded to therapy).

Key Dates

Start date
Jan 25, 2023
Status verified
Apr 2026
Primary completion
Apr 28, 2027
Completion
Apr 28, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pirtobrutinib (LOXO-305) and Venetoclax (combination)
    Participants will have study visits every week during Cycle 1, and then on Day 1 of every cycle for the first year. After that, they will have study visits on Day 1 of every 2 cycles.

Primary Outcome Measure

ORR (overall response rate) [ Time Frame: through study completion an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Preetesh Jain, MD, DM, PhD
[email protected]
713-563-8786
Preetesh Jain, MD (PRINCIPAL_INVESTIGATOR)

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M D Anderson Cancer Center· Houston, TX

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