Pirtobrutinib and Venetoclax in Waldenström Macroglobulinemia

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT05734495
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Waldenstrom Macroglobulinemia

Eligibility Criteria

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

Interventions

  • Pirtobrutinib — DRUG
    Noncovalent Bruton Tyrosine Kinase (BTK) inhibitor, tablet taken orally.
  • Venetoclax — DRUG
    Small-molecule B-cell lymphoma-2 (Bcl-2) family inhibitor, tablet taken orally.

Study Details

This study is being done to examine the safety and effectiveness of pirtobrutinib combined with venetoclax as a possible treatment for participants with Waldenström Macroglobulinemia (WM). The names of the study drugs involved in this study are: * Pirtobrutinib (a Noncovalent Bruton Tyrosine Kinase (BTK) inhibitor) * Venetoclax (a BCL2 inhibitor)

Key Dates

Start date
May 2, 2023
Status verified
May 2026
Primary completion
Jan 25, 2029
Completion
Jan 25, 2033

Study Design

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

Arms

  • Experimental: PIRTOBRUTINIB + VENETOCLAX
    Participants will receive: * Standard of care bone marrow aspirate \& biopsy within 90 days of Cycle 1 Day 1. * Computed Tomography (CT) scan of chest, pelvis \& abdomen within 90 days of Cycle 1 Day 1. * Electrocardiogram at screening. * Cycle 1 * Electrocardiogram. * Day 1-28: Predetermined dose of Pirtobrutinib 1x daily. * Cycle 2 -Day 1-28: Predetermined dose Pirtobrutinib \& Venetoclax 1x daily. Tumor lysis syndrome (TLS) prophylaxis, predetermined dose Allopurinol at least 72 hrs prior to 1st administration of Venetoclax and dose escalation at Day 8 \& Day 15. * Cycles 3-24 * Day 1-28: Predetermined dose of Pirtobrutinib \& Venetoclax 1x daily. * Electrocardiogram: Cycles 3, 6, 9,12,15,18,21,24 * CT scan of chest, pelvis \& abdomen: Cycles 7, 13, End of Treatment if extramedullary disease at baseline unresolved in previous CT scan * Standard of care bone marrow aspirate and biopsy: Cycles 7, 13, End of Treatment * Follow up every 12 wks for 4 yrs.

Primary Outcome Measure

Very Good Partial Response (VGPR) or Better Response Rate [ Time Frame: up to 2 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconness MedicalBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02215-

Find similar trials in Boston, MA

By research site
Beth Israel Deaconness Medical· Boston, MADana Farber Cancer Institute· Boston, MA

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