Actively Recruiting
Clinical Trial to Evaluate the Efficacy and Safety of Pirtobrutinib With Rituximab in Patients With Mantle Cell Lymphoma
Led by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea · Updated on 2025-12-16
50
Participants Needed
16
Research Sites
374 weeks
Total Duration
On this page
Sponsors
G
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Lead Sponsor
E
Evidenze CRO
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Trial to Evaluate the Efficacy and Safety of Pirtobrutinib With Rituximab in Patients With Mantle Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients 18 years of age or older
- Written informed consent obtained before any study assessments
- Confirmed diagnosis of Mantle Cell Lymphoma (classical, small-cell, or marginal-zone variants) according to 2022 classifications
- No prior therapy for MCL except diagnostic splenectomy
- Asymptomatic patients
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Clinical stage I-IV with no symptoms caused by MCL
- Eligible if leukemic non-nodal presentation with mainly bone marrow or peripheral blood involvement or low tumor burden, including lymph node enlargement 3 cm or smaller and Ki67 less than 30%
- Laboratory values within required ranges for neutrophils, hemoglobin, platelets, liver enzymes, bilirubin, kidney function, and coagulation
- Stable disease without clinical progression for at least 3 months
- Negative pregnancy test for females of child-bearing potential and agreement to use effective contraception during and after treatment
- Males agreeing to use effective contraception if sexually active with females of child-bearing potential
- Willing and able to provide signed informed consent and comply with study requirements
- Not enrolled in another clinical trial or treated with an experimental drug unrelated to MCL within the past 2 years
You will not qualify if you...
- Aggressive histological variants of MCL (blastoid and pleomorphic)
- B-cell monoclonal lymphocytosis with MCL phenotype
- Presence of B symptoms or other significant symptoms related to MCL
- Lymph node enlargement larger than 3 cm
- Organ dysfunction related to MCL including creatinine above 2 mg/dl or liver biochemistry over three times the upper limit
- Serum lactate dehydrogenase (LDH) above normal
- Known central nervous system involvement
- Expected need for MCL therapy within less than 3 months
- Requirement for vitamin K antagonist anticoagulation
- History of bleeding disorders
- Stroke or intracranial hemorrhage within 6 months before enrollment
- Significant cardiovascular diseases including recent unstable angina, heart attack, reduced heart function, severe heart failure, or uncontrolled arrhythmias
- QT interval corrected for heart rate (QTcF) over 470 msec unless safely corrected
- Positive HIV test or active hepatitis B or C infection
- Known active cytomegalovirus infection
- Other cancers within last 2 years except certain skin or cervical cancers
- Major surgery or live vaccine within 4 weeks before study
- Active autoimmune blood disorders requiring recent therapy changes
- Other significant uncontrolled infections or diseases posing risk
- Known allergies to pirtobrutinib, rituximab, or their excipients
- Pregnancy, breastfeeding, or plans for pregnancy during study or within specified post-treatment periods
- Inability to take oral medication or conditions affecting drug absorption
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Instituto Português de Oncologia de Lisboa Francisco Gentil
Lisbon, Lisbon District, Portugal, 1099-023
Actively Recruiting
2
Unidade Local De Saude De Santa Maria E.P.E.
Lisbon, Lisbon District, Portugal, 1649-028
Not Yet Recruiting
3
INSTITUT CATALÀ D'ONCOLOGIA (ICO). Hospital Germans Trias I Pujol.
Badalona, Barcelona, Spain, 08916
Not Yet Recruiting
4
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain, 08035
Actively Recruiting
5
Hospital Clinic de Barcelona
Barcelona, Barcelona, Spain, 08036
Actively Recruiting
6
Institut Català d'oncologia de L'Hospitalet (ICO-L'Hospitalet)
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Not Yet Recruiting
7
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, Spain, 28007
Actively Recruiting
8
Clínica Universidad Navarra
Madrid, Madrid, Spain, 28027
Actively Recruiting
9
Hospital Ramon y Cajal
Madrid, Madrid, Spain, 28034
Actively Recruiting
10
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain, 28041
Actively Recruiting
11
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120
Actively Recruiting
12
Hospital Costa del Sol
Marbella, Málaga, Spain, 29603
Actively Recruiting
13
Clínica Universidad Navarra
Pamplona, Pamplona, Spain, 31008
Actively Recruiting
14
Hospital Universitario de Salamanca
Salamanca, Salamanca, Spain, 37007
Actively Recruiting
15
Hospital Clínico de Valencia
Valencia, Valencia, Spain, 46010
Actively Recruiting
16
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, Spain, 46026
Not Yet Recruiting
Research Team
A
Auxi Moreno
CONTACT
A
Ana María Méndez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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