A Phase 2 Study to Evaluate the Safety and Efficacy of Pacritinib in Relapsed or Refractory Waldenström Macroglobulinemia

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Shayna Sarosiek, MD
Study ID
NCT06986174
Phase
PHASE2
Status
Recruiting
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Conditions

  • B-Cell Lymphoproliferative Disorder
  • Indolent Lymphoma
  • Lymphoplasmacytic Lymphoma
  • Waldenström Macroglobulinemia

Eligibility Criteria

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

Interventions

  • Pacritinib — DRUG
    Kinase inhibitor, capsule, taken orally per protocol.

Study Details

This study is being done to examine the safety and effectiveness of pacritinib as a possible treatment for participants with Waldenström macroglobulinemia (WM). The name of the study drug involved in this study is: -Pacritinib (a type of kinase inhibitor)

Key Dates

Start date
Nov 21, 2025
Status verified
Dec 2025
Primary completion
Oct 1, 2028
Completion
Oct 1, 2032

Study Design

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

Arms

  • Experimental: Pacritinib
    30 participants will complete: * Baseline visit with assessments and ECGs * Cycles 1 through 2 (28 days per cycle): --Day 1: Predetermined dose of Pacritinib 2x daily * Cycle 3, 6, 9, 12, and every 3 cycles for 48 cycles total (28 days per cycle): --Day 1: Predetermined dose of Pacritinib 2x daily * Bone marrow biopsies/aspirations at Cycles 6 and 12 and then yearly * End of Treatment visit with CT scan and bone marrow biopsy/aspiration * Follow up: every 12 weeks for 2 years

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to 48 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02115
Shayna Sarosiek, MD
[email protected]
617-632-4218
Shayna Sarosiek, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Dana Farber Cancer Institute· Boston, MA

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