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Tests treatment safety and results for Waldenström Macroglobulinemia
Official title A Phase 2 Study to Evaluate the Safety and Efficacy of Pacritinib in Relapsed or Refractory Waldenström Macroglobulinemia
ClinicalTrials.gov ID: NCT06986174
What this study is testing
What is Pacritinib?
Pacritinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for waldenström macroglobulinemia.
Also referred to as SB1518, VONJO.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
- Time commitment: about 4 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years
- ECOG performance status ≤2
- Clinicopathological diagnosis of Waldenström Macroglobulinemia
- Symptomatic disease meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenström...
- constitutional symptoms: recurrent fever, night sweats, fatigue or weight loss
You likely can't join if
- Current history of uncontrolled HIV
- 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...
- Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below
- Hepatitis B virus (HBV): Patients with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody...
- Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for...
- Participants with chronic liver disease and hepatic impairment meeting Child-Pugh class B or C (Appendix B)
See the full eligibility criteria
- Age ≥18 years
- ECOG performance status ≤2
- Clinicopathological diagnosis of Waldenström Macroglobulinemia
- Symptomatic disease meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenström macroglobulinemia. At least one of the following:
- constitutional symptoms: recurrent fever, night sweats, fatigue or weight loss
- progressive or symptomatic lymphadenopathy or splenomegaly
- hemoglobin ≤10 g/dL
- platelet count ≤100 k/uL
- hyperviscosity syndrome
- symptomatic peripheral neuropathy
- systemic amyloidosis
- renal insufficiency
- symptomatic cryoglobulinemia
- Serum IgM level ≥ 2 times the upper limit of normal
- Participants must meet the following organ and marrow functions as defined below:
- absolute neutrophil count ≥0.5 k/uL without growth factor within 7 days
- platelet count ≥50 k/uL without platelet transfusion within 7 days
- 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
- 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
- Creatinine clearance ≥30 ml/min using Cockcroft/Gault equation
- Ability to understand and the willingness to sign a written informed consent document. (Providing consents in as many languages as possible is encouraged)
- 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.
- 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...
- 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.
- Current history of uncontrolled HIV
- 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.
- Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below
- 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...
- 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...
- Participants with chronic liver disease and hepatic impairment meeting Child-Pugh class B or C (Appendix B)
- 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)
- Current CNS involvement by WM
- Active alcohol or drug abuse
- 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.
- Concurrent participation in another therapeutic clinical trial
- 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...
- 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...
- Inability to swallow pills
- Significant cardiovascular disease defined as:
- Unstable angina, or
- History of myocardial infarction within 6 months prior to planned start
- 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...
- Any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or
- Uncontrolled or symptomatic arrhythmias
- Prolonged QT Interval with baseline QTc \>480 msec using the Bazette formula
- Ongoing, active infection.
- Active bleeding requiring blood transfusion or other medical intervention. Participants requiring anticoagulation therapy are not excluded.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.