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New treatment option for Mantle Cell Lymphoma
Official title Phase 2 Open Label Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in R/R MCL
ClinicalTrials.gov ID: NCT06553872
What this study is testing
What is Pirtobrutinib?
Pirtobrutinib is an investigational medicine, being studied as a potential treatment for mantle cell lymphoma.
Also referred to as Jaypirca.
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 is a phase 2, open-label, randomized, multicenter clinical trial in patients with relapsed/refractory mantle cell lymphoma (R/R MCL) who meet the criteria for standard-of-care FDA label for CD19 CAR T-cell therapy with brexucabtagene autoleucel (brexu-cel).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Patients with a histologically confirmed diagnosis of mantle cell lymphoma (MCL) will be eligible.
- Adult males or females who are 18 years of age or older at time of signing informed consent.
- Must have ability to comprehend and the willingness to sign written informed consent for study participation.
- Eligible to receive CAR T-cell therapy (Brexucabtagene autoleucel) for MCL by the standard of care label, which states: "TECARTUS or Brexucabtagene...
- ECOG performance status 0 to 2.
You likely can't join if
- Patients who have previously received treatment with pirtobrutinib for \>2 months prior to study enrollment are ineligible. Patients who are relapsed...
- Patients who have previously discontinued pirtobrutinib due to disease progression, intolerance, or toxicity.
- Patients who are currently receiving or who have received any investigational study agent ≤4 weeks prior to screening visit are ineligible.
- Prior treatment with chimeric antigen receptor (CAR) T-cell therapy.
- Participants with clinically significant or uncontrolled cardiac disease, including unstable angina or acute coronary syndrome within the past 2...
- Uncontrolled or symptomatic arrhythmias, including prolongation of the QT interval corrected for heart rate (QTcF) \> 470 msec. QTcF is calculated...
See the full eligibility criteria
Who can join
- Patients with a histologically confirmed diagnosis of mantle cell lymphoma (MCL) will be eligible.
- Adult males or females who are 18 years of age or older at time of signing informed consent.
- Must have ability to comprehend and the willingness to sign written informed consent for study participation.
- Eligible to receive CAR T-cell therapy (Brexucabtagene autoleucel) for MCL by the standard of care label, which states: "TECARTUS or Brexucabtagene autoleucel is a CD19-directed genetically modified autologous T-cell...
- ECOG performance status 0 to 2.
- Patients are required to have the following washout periods prior to leukapheresis. In addition, prior treatment-related AEs must have recovered to Grade ≤ 1 with the exception of alopecia and Grade 2 peripheral...
- Targeted agents (i.e. BTK inhibitors), investigational agents, therapeutic monoclonal antibodies or cytotoxic chemotherapy: 5 half-lives or 2 weeks, whichever is shorter
- Antibody-drug conjugates (ADC): 10 weeks
- Radiation therapy: Broad field radiation (≥ 30% of the bone marrow or whole brain radiotherapy): 14 days. Palliative limited field radiation: 7 days. Note: In the case of known central nervous system (CNS) involvement...
- Bendamustine or other purine analogues: 3 months.
- Corticosteroids: 5 days
- The effects of Pirtobrutinib on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must...
- Men must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through safety follow up and must refrain from donating sperm during this period. Permitted methods...
- Willingness of women of reproductive potential and their partners to observe highly effective birth control methods for the duration of treatment and for 1 month following the last dose of study treatment (see Section...
- Women of childbearing potential must have a negative serum pregnancy test at screening and before the first dose of pirtobrutinib and must agree to take appropriate precautions to avoid pregnancy (with at least 99%...
- Women of non-childbearing potential (i.e. surgically sterile with a hysterectomy and/or bilateral oophorectomy OR \>= 12 months of amenorrhea) are eligible.
- Patients must meet the following laboratory parameters at screening:
- Hematology (criteria the same regardless of bone marrow involvement; must be independent of transfusions and G-CSF support within 7 days of assessment)
- Platelets \>= 50 x 10\^9/L
- Hemoglobin \>= 8g/dL
- Absolute Neutrophil Count \>=1.0 x 10\^9/L
- Hepatic
- ALT \< 2.5 x ULN for age, \<5 x ULN in the presence of liver metastases
- AST \< 2.5 x ULN for age, \<5 x ULN in the presence of liver metastases
- Total bilirubin \< 1.5 x ULN or \<3 x ULN in the presence of documented Gilbert's syndrome unconjugated hyperbilirubinemia)
- Renal Creatinine clearance \>= 30 mL/minute based on Cockcroft-Gault formula.
- Cardiopulmonary Cardiac LVEF \>=40% confirmed by ECHO/multigated analysis
- Adequate pulmonary function \<= Grade 2 dyspnea and \<= Grade 2 hypoxia per CTCAE v5.0.
- 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.
What rules you out
- Patients who have previously received treatment with pirtobrutinib for \>2 months prior to study enrollment are ineligible. Patients who are relapsed or refractory and then received less than 2 months of pirtobrutinib...
- Patients who have previously discontinued pirtobrutinib due to disease progression, intolerance, or toxicity.
- Patients who are currently receiving or who have received any investigational study agent ≤4 weeks prior to screening visit are ineligible.
- Prior treatment with chimeric antigen receptor (CAR) T-cell therapy.
- Participants with clinically significant or uncontrolled cardiac disease, including unstable angina or acute coronary syndrome within the past 2 months prior to randomization, history of myocardial infarction within 3...
- Uncontrolled or symptomatic arrhythmias, including 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...
- Evidence of active uncontrolled/untreated infection (viral, bacterial, fungal, opportunistic) of any origin.
- Participants with active immunologic or inflammatory/autoimmune disease affecting the CNS, and unrelated to their disease under study or previous treatment.
- Patients with active CNS involvement of Mantle Cell Lymphoma. A history of CNS Mantle Cell Lymphoma is allowed, as long as it has cleared, and the patient is able to comply with study procedures. Patients with previous...
- Known positive Human immunodeficiency virus (HIV) status. For patients with unknown HIV status, HIV testing will be performed at Screening and result must be negative for enrollment.
- 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...
- 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 randomization. Patients who are...
- Known active cytomegalovirus (CMV) infection. Unknown or negative status are eligible.
- Participants who require the concurrent use of chronic systemic steroids or immunosuppressant medications. Steroids should not be given within 5 days prior to leukapheresis. Concomitant bridging steroids (section 6.6)...
- Known hypersensitivity or severe reaction to pirtobrutinib, similar compounds, or excipients.
- Participants who have not recovered from adverse events (AEs) due to prior anticancer therapy (i.e., have residual toxicities \> Grade 1), with the exception of stable Grade 2 peripheral neuropathy and/or any grade...
- Pregnant or nursing (breast-feeding) women are excluded from this study because there is an unknown but potential risk to using pirtobrutinib in pregnant or nursing women. Patients are excluded if they are pregnant or...
- Any condition that would, in the investigator's judgement, interfere with full participation in the study, including administration of pirtobrutinib and attending required study visits (if outpatient); pose a...
- Inability of the participant to swallow and retain oral medication. Or, if there is clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the study...
- 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...
- Major surgery within 4 weeks prior to enrollment.
- History of a previously diagnosed hereditary bleeding disorder.
- Patients requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist.
- Active second malignancy unless in remission and with life expectancy \> 2 years.
- Vaccination with live vaccine within 28 days prior to randomization.
- History of stroke or intracranial hemorrhage within 6 months of enrollment.
- History of allogeneic or autologous stem cell transplant within 60 days of enrollment, presence of either of the following regardless of prior stem cell transplant timing: active graft vs. host disease; cytopenias from...
- Active uncontrolled autoimmune cytopenia, including autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura for which new therapy was introduced or existing therapy was escalated within the 4 weeks prior to...
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
- Miami, Florida, United States
- Tampa, Florida, 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 Stanford, California, United States; Miami, Florida, United States; Tampa, Florida, 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.