RECRUITING

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

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Conditions

Waldenström MacroglobulinemiaLymphoplasmacytic LymphomaB-Cell Lymphoproliferative DisorderIndolent LymphomaLymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

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

Quick Facts

Study Start:2025-09
Study Completion:2032-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06986174

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥18 years
  2. * ECOG performance status ≤2
  3. * Clinicopathological diagnosis of Waldenström Macroglobulinemia
  4. * Symptomatic disease meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenström macroglobulinemia. At least one of the following:
  5. * constitutional symptoms: recurrent fever, night sweats, fatigue or weight loss
  6. * progressive or symptomatic lymphadenopathy or splenomegaly
  7. * hemoglobin ≤10 g/dL
  8. * platelet count ≤100 k/uL
  9. * hyperviscosity syndrome
  10. * symptomatic peripheral neuropathy
  11. * systemic amyloidosis
  12. * renal insufficiency
  13. * symptomatic cryoglobulinemia
  14. * Serum IgM level ≥ 2 times the upper limit of normal
  15. * Participants must meet the following organ and marrow functions as defined below:
  16. * absolute neutrophil count ≥0.5 k/uL without growth factor within 7 days
  17. * platelet count ≥50 k/uL without platelet transfusion within 7 days
  18. * total bilirubin ≤1.5 times the upper limit of normal or ≤3 times the upper limit of normal with documented liver involvement, hemolysis or Gilbert's disease
  19. * AST (SGOT) and ALT (SGPT) ≤2.5 times the upper limit of normal or ≤5 times the upper limit of normal with documented liver involvement
  20. * Creatinine clearance ≥30 ml/min using Cockcroft/Gault equation
  21. * Ability to understand and the willingness to sign a written informed consent document. (Providing consents in as many languages as possible is encouraged)
  22. * At least 2 prior lines of treatment for Waldenström Macroglobulinemia. Participants must either be BTK inhibitor exposed or not be a candidate for BTK therapy.
  23. * Women of childbearing potential: Females of childbearing potential (FCBP) will be required to use two highly effective forms of contraception simultaneously or will remain abstinent from heterosexual intercourse during the following periods related to this study:
  24. 1. while participating in the study; and 2) for at least three months (90 days) after discontinuation from the study. FCBP must be referred to a qualified provider of contraceptive methods if needed.
  1. * Current history of uncontrolled HIV
  2. * Patients with a known history of HIV must have a viral load assessed for eligibility and must be on a stable antiretroviral regimen that can be administered concurrent with pacritinib.
  3. * Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below
  4. * Hepatitis B virus (HBV): Patients with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody (antiHBc) and negative HBsAg require hepatitis B polymerase chain reaction (PCR) evaluation before enrollment. Patients who are hepatitis B PCR positive will be excluded.
  5. * Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA) before enrollment. Patients who are hepatitis C RNA positive will be excluded.
  6. * Participants with chronic liver disease and hepatic impairment meeting Child-Pugh class B or C (Appendix B)
  7. * Participants who are pregnant, breast feeding, or planning to become pregnant while enrolled in this study or within 3 month after last study dose (2 weeks for breastfeeding)
  8. * Current CNS involvement by WM
  9. * Active alcohol or drug abuse
  10. * Concurrent administration of medications that are moderate or strong inhibitors or inducers of CYP3A within 14 days or 5 half-lives, whichever is shorter, prior to first dose of study drug.
  11. * Concurrent participation in another therapeutic clinical trial
  12. * History of another malignancy, except adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, localized prostate cancer, or other adequately treated cancer currently in complete remission
  13. * Prior or ongoing clinically significant illness, including active infections requiring antibiotics, of medical condition that, in the investigator's opinion, could affect the safety of the patient; alter the absorption, distribution, metabolism or excretion of the study drug; or impair the assessment of study results
  14. * Inability to swallow pills
  15. * Significant cardiovascular disease defined as:
  16. * Unstable angina, or
  17. * History of myocardial infarction within 6 months prior to planned start
  18. * Previously documented left ventricular ejection fraction (LVEF) by any method of ≤ 45% in the 12 months prior to planned start; assessment of LVEF via echocardiogram or multigated acquisition (MUGA) scan during screening should be performed in selected patients as medically indicated, or
  19. * Any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or
  20. * Uncontrolled or symptomatic arrhythmias
  21. * Prolonged QT Interval with baseline QTc \>480 msec using the Bazette formula
  22. * Ongoing, active infection.
  23. * Active bleeding requiring blood transfusion or other medical intervention. Participants requiring anticoagulation therapy are not excluded.

Contacts and Locations

Study Contact

Shayna Sarosiek, MD
CONTACT
617-632-4218
Shayna_Sarosiek@dfci.harvard.edu

Principal Investigator

Shayna Sarosiek, MD
PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute

Study Locations (Sites)

Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Shayna Sarosiek, MD

  • Shayna Sarosiek, MD, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09
Study Completion Date2032-10-01

Study Record Updates

Study Start Date2025-09
Study Completion Date2032-10-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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