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New treatment option for Waldenstrom Macroglobulinemia
Official title A Study of Pirtobrutinib, Venetoclax, and Rituximab in People With Waldenström's Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL)
ClinicalTrials.gov ID: NCT07231952
What this study is testing
What is Pirtobrutinib?
Pirtobrutinib is an investigational medicine, being studied as a potential treatment for waldenstrom macroglobulinemia.
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
- The purpose of this study is to find out if the combination of pirtobrutinib, venetoclax, and rituximab is an effective treatment for participants with Waldenström's macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL)
- Phase 2: a mid-size study of how well it works
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 greater than or equal to 18 years
- Histologically confirmed treatment naive WM/LPL
- Patients must have measurable disease as defined by at least one lymph node ≥1.5 cm and/ or IgM levels \> 0.5gm/dl quantified by using densitometry...
- Participants must have at least one of the established criteria to require therapy for WM, including anemia, thrombocytopenia, neuropathy related to...
- ECOG performance status ≤2
You likely can't join if
- Prior/Concomitant Therapy: Participants must not have had prior systemic therapy.
- Medical Conditions
- Major surgery within 4 weeks prior to start of treatment
- History of bleeding diathesis
- Patients who experienced a major bleeding event or grade ≥ 3 arrhythmia on prior treatment with a BTK inhibitor.
- NOTE: Major bleeding is defined as bleeding having one or more of the following features: potentially life-threatening bleeding with signs or...
See the full eligibility criteria
Who can join
- Age greater than or equal to 18 years
- Histologically confirmed treatment naive WM/LPL
- Patients must have measurable disease as defined by at least one lymph node ≥1.5 cm and/ or IgM levels \> 0.5gm/dl quantified by using densitometry on serum protein electrophoresis (SPEP) or quantitative nephelometry.
- Participants must have at least one of the established criteria to require therapy for WM, including anemia, thrombocytopenia, neuropathy related to WM, symptomatic hyperviscosity or serum viscosity levels greater than...
- ECOG performance status ≤2
- Platelet count ≥ 50,000 cells/mm3, independent of transfusions within 7 days of screening assessment
- Hemoglobin ≥ 8 g/dL, unless due to disease involvement in which case ≥ 7 g/dL, independent of transfusions within 7 days of screening assessment
- Absolute neutrophil count \>1000 cells/mcL, independent of growth factor support within 7 days of screening assessment
- Total bilirubin \< 1.5 x upper normal institutional limits. In patients with Gilbert's disease total bilirubin up to 3x ULN will be allowed
- AST(SGOT)/ALT(SGPT) \< 3 x institutional upper limit of normal unless elevation is caused by liver involvement with WM in which case AST and ALT may be ≤ 5 x ULN
- Creatinine within normal institutional limits OR Creatinine clearance \>40 mL/min for patients with creatinine levels above institutional normal (by Cockcroft-Gault estimate or 12-24h creatinine clearance measurements)
- Adequate coagulation, defined as activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) and prothrombin (PT) or (international normalized ratio (INR) not greater than 1.5 x ULN
- Ability to understand and the willingness to sign a written informed consent document.
- Patient must be able to swallow pills
- Patients with Hepatitis B surface antibody serum positivity due to prior immunization, as well as those with Hepatitis B core antibody positivity with negative PCR on antiviral therapy will be eligible.
- Willingness of participants of reproductive potential and their partners to observe highly effective birth control methods for the duration of treatment and for 1 year following the last dose of study treatment
What rules you out
- Prior/Concomitant Therapy: Participants must not have had prior systemic therapy.
- Medical Conditions
- Major surgery within 4 weeks prior to start of treatment
- History of bleeding diathesis
- Patients who experienced a major bleeding event or grade ≥ 3 arrhythmia on prior treatment with a BTK inhibitor.
- NOTE: Major bleeding is defined as bleeding having one or more of the following features: potentially life-threatening bleeding with signs or symptoms of hemodynamic compromise; bleeding associated with a decrease in...
- History of stroke or intracranial hemorrhage within 6 months of start of treatment
- History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor-modified T-cell (CAR-T) therapy within 60 days of start of treatment or presence of any of the following, regardless of prior...
- active graft versus host disease (GVHD);
- cytopenia from incomplete blood cell count recovery post-transplant;
- need for anti-cytokine therapy for toxicity from CAR-T therapy; residual symptoms of neurotoxicity \> Grade 1 from CAR-T therapy;
- ongoing immunosuppressive therapy (\> 20 mg prednisone or equivalent daily).
- Significant cardiovascular disease defined as:
- unstable angina or acute coronary syndrome within the past 2 months prior to start of treatment
- history of myocardial infarction within 3 months prior to start of treatment or
- documented LVEF by any method of ≤ 40% in the 12 months prior to start of treatment
- ≥ Grade 3 NYHA functional classification system of heart failure
- Uncontrolled or symptomatic arrhythmias
- Prolongation of the QT interval corrected for heart rate (QTcF) \> 470 msec. QTcF is calculated using Fridericia's Formula (QTcF): QTcF = QT/(RR0.33).
- Correction of suspected drug-induced QTcF prolongation can be attempted at the investigator's discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug...
- Correction for underlying bundle branch block (BBB) allowed. Note: Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker
- Patients who have tested positive for Human Immunodeficiency Virus (HIV) are excluded due to risk of opportunistic infections with both HIV and BTK- inhibitors. For patients with unknown HIV status, HIV testing will 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 (anti-HBc) and negative HBsAg require a negative hepatitis B polymerase chain reaction (PCR) evaluation before start of treatment.
- Patients who are HBV DNA PCR positive will be excluded.
- 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 start of treatment. Patients who...
- Known active cytomegalovirus (CMV) infection. Unknown or negative status are eligible.
- Pregnancy or plan to become pregnant during the study or within 1 month of the last dose of study treatment.
- Lactation or plan to breastfeed during the study or within 1 week of the last dose of study treatment.
- Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the study drug.
- Evidence of other clinically significant uncontrolled condition(s) including but not limited to, uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or other...
- Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP]) for which new therapy was introduced or existing therapy was escalated within the 4 weeks...
- Active second malignancy unless in remission and with life expectancy \> 2 years.
- Patients requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist.
- Vaccination with live vaccine within 28 days prior to start of treatment
- Other Exclusions
- Have a known hypersensitivity to any of the excipients of Pirtobrutinib or to any intended study medications.
- Participants who require ongoing use or received a moderate or strong CYP3A inducer, moderate or strong CYP3A inhibitor, P-gp inhibitor within 7 days prior to the first dose of study drug
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States and 2 more location(s). 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.