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Tests treatment safety and results for Mantle Cell Lymphoma (MCL)
Official title Clinical Trial to Evaluate the Efficacy and Safety of Pirtobrutinib With Rituximab in Patients With Mantle Cell Lymphoma
ClinicalTrials.gov ID: NCT07285590
What this study is testing
What is Pirtobrutinib and rituximab?
Pirtobrutinib and rituximab is an investigational medicine, being studied as a potential treatment for mantle cell lymphoma (mcl).
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 multicenter, international, open-label, single-arm phase II clinical trial designed to evaluate the activity and safety of a combination therapy with pirtobrutinib and rituximab (P-R) in treatment-naïve adult patients diagnosed with indolent clinical forms of Mantle Cell Lymphoma (MCL). The study applies a Simon's two-stage design, with an interim analysis after the first 16 patients to determine continuation based on complete remission rate (CRR) after 6 cycles.
- 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
- Adult patients (≥18 years of age).
- Written informed consent must be obtained before any study-specific assessment is performed.
- people with confirmed diagnosis of Mantle Cell Lymphoma according to the International Consensus Classification, (ICC) 2022] or World Health...
- Naïve patients for MCL management (no prior therapies, excluding diagnostic splenectomy)
- Asymptomatic patients
You likely can't join if
- people with aggressive histological variants: blastoid and pleomorphic variants of MCL
- B-cell monoclonal lymphocytosis with MCL phenotype
- Presence of B symptoms or any relevant symptoms related to the MCL.
- Nodal clinical forms with lymph node enlargement \> 3 cm (largest diameter).
- Organ dysfunction related to MCL including creatinine level \> 2 mg/dl or altered liver biochemistry (\> 3x ULN).
- Serum LDH over ULN
See the full eligibility criteria
Who can join
- Adult patients (≥18 years of age).
- Written informed consent must be obtained before any study-specific assessment is performed.
- people with confirmed diagnosis of Mantle Cell Lymphoma according to the International Consensus Classification, (ICC) 2022] or World Health Organization (WHO) Classification 2022. Classical, small-cell variants and...
- Naïve patients for MCL management (no prior therapies, excluding diagnostic splenectomy)
- Asymptomatic patients
- Eastern Cooperative Oncology Group (ECOG) performance status \<2 (0-1)
- Clinical stage I-IV according to the Ann Arbor classification with no symptoms attributable to MCL
- Patients with a leukemic non-nodal presentation with mainly bone marrow or peripheral blood involvement are eligible. Other asymptomatic clinical presentations are acceptable in case of low tumour burden, including MCL...
- The following laboratory values at screening:
- Neutrophil count ≥ 1×109/L, Haemoglobin level ≥ 100 g/L and platelet count ≥100×109/L
- Transaminases (AST and ALT) ≤ 3 x ULN
- Total bilirubin ≤1.5 x ULN unless bilirubin rise is due to Gilbert's disease
- Calculated creatinine clearance ≥ 30 ml/min according to Cockcroft/Gault Formula (140 - age) × body weight (kg) × 0.85 (if female)/ serum creatinine (mg/dL) × 72
- 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.
- Stable disease without evidence of clinical progression for at least 3 months. Patients in prolonged observation may be included (over 3 months).
- Female patients of child-bearing potential must have a negative serum pregnancy test at screening and agree to use highly effective contraception from the start of study treatment (See Appendix 4), during the treatment...
- Male patients must use highly effective contraception (if sexually active with a female of child-bearing potential) according to the recommendations provided by the Clinical Trial Facilitation and Coordination Group...
- Willing and capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
- Not included in other clinical trial or treated with an experimental drug unrelated to MCL within the past 2 years
What rules you out
- people with aggressive histological variants: blastoid and pleomorphic variants of MCL
- B-cell monoclonal lymphocytosis with MCL phenotype
- Presence of B symptoms or any relevant symptoms related to the MCL.
- Nodal clinical forms with lymph node enlargement \> 3 cm (largest diameter).
- Organ dysfunction related to MCL including creatinine level \> 2 mg/dl or altered liver biochemistry (\> 3x ULN).
- Serum LDH over ULN
- Known central nervous system (CNS) infiltration.
- Expected MCL therapy requirement in a short time (\< 3 months)
- Anticoagulation requirement with vitamin K antagonists
- History of bleeding diathesis
- Past medical history of stroke or intracranial haemorrhage within 6 months prior to inclusion.
- Significant cardiovascular disease defined as: i) unstable angina or acute coronary syndrome within the past 2 months prior to randomization; ii) history of myocardial infarction within 3 months prior to randomization...
- 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...
- 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) infection based on criteria below: Patients with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody (anti-HBc) and negative...
- 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 inclusion. Patients who are...
- Known active cytomegalovirus (CMV) infection. Unknown or negative status are eligible.
- Concomitant or previous malignancies the last 2 years other than basal skin cancer or in situ uterine cervix cancer.
- Major surgery within 4 weeks of inclusion.
- Vaccinated with live, attenuated vaccines within 4 weeks of inclusion.
- Active uncontrolled auto-immune cytopenia (e.g., autoimmune haemolytic anaemia [AIHA], idiopathic thrombocytopenic purpura [ITP]) for which new therapy was introduced or existing therapy was escalated within the 4 weeks...
- 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 any other...
- Known hypersensitivity to any of the excipients of Pirtobrutinib or Rituximab or any intended study medications.
- Females who are pregnant or breastfeeding or plan to become pregnant or initiate breastfeeding during the study or within 1 month of the last dose of pirtobrutinib or 12 months of the last dose of rituximab.
- Patients unable to take oral medication or with clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug.
The study team makes the final eligibility decision.
Where it's taking place
- Lisbon, Lisbon District, Portugal
- Badalona, Barcelona, Spain
- Barcelona, Barcelona, Spain
- L'Hospitalet de Llobregat, Barcelona, Spain
- Madrid, Madrid, Spain
- El Palmar, Murcia, Spain
- Marbella, Málaga, Spain
- Pamplona, Pamplona, Spain
- Salamanca, Salamanca, Spain
- Valencia, Valencia, Spain
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 Lisbon, Lisbon District, Portugal; Badalona, Barcelona, Spain; Barcelona, Barcelona, Spain; L'Hospitalet de Llobregat, Barcelona, Spain; Madrid, Madrid, Spain; El Palmar, Murcia, Spain and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.