Actively Recruiting
International Multicentric Phase II Trial to Evaluate the Efficacy and Safety of Pirtobrutinib in Combination With Rituximab in Patients With Indolent Clinical Forms of 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
N/A
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
Researchers are investigating a combination therapy using pirtobrutinib and rituximab for adults newly diagnosed with indolent forms of Mantle Cell Lymphoma (MCL), a type of blood cancer. This international, open-label phase II trial aims to evaluate the activity and safety of this treatment. The study uses a two-stage design to assess the complete remission rate after six cycles of treatment, focusing on improving responses and reducing treatment toxicity compared to current therapies. Participants will receive the combination therapy starting at day 1 of the first cycle and continue for at least 24 cycles, each lasting 28 days. Rituximab treatment will conclude after 23 cycles, while pirtobrutinib continuation depends on minimal residual disease status and specific genetic markers. The study also includes detailed biological analyses to better understand the treatment's effects on this lymphoma subtype. Throughout the study, participants will undergo regular assessments including blood tests, disease evaluations, and quality of life surveys at multiple time points up to 48 months. Researchers will monitor treatment safety, response rates, and molecular disease markers to measure effectiveness and tolerability. This comprehensive follow-up aims to capture long-term outcomes and support development of improved first-line therapies for indolent MCL.
CONDITIONS
Brief 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)
- Signed informed consent before any study assessments
- Confirmed diagnosis of Mantle Cell Lymphoma according to ICC 2022 or WHO Classification 2022, including classical, small-cell, and marginal-zone variants
- No prior therapies for MCL management (except diagnostic splenectomy)
- Asymptomatic patients
- ECOG performance status less than 2 (0-1)
- Clinical stage I-IV with no symptoms related to MCL
- Eligible patients with leukemic non-nodal presentation or low tumour burden (lymph node enlargement ≤ 3 cm and Ki67 < 30%)
- Specific laboratory values within defined limits at screening
- Stable disease without progression for at least 3 months
- Female patients of child-bearing potential must have a negative pregnancy test and agree to use effective contraception during and after treatment
- Male patients must agree to use effective contraception during and after treatment
- Willing and able to provide informed consent and comply with study requirements
- Not currently enrolled in other clinical trials or treated with experimental drugs unrelated to MCL within past 2 years
You will not qualify if you...
- Aggressive histological variants: blastoid and pleomorphic MCL
- B-cell monoclonal lymphocytosis with MCL phenotype
- Presence of symptoms related to MCL
- Lymph node enlargement greater than 3 cm
- Organ dysfunction related to MCL including high creatinine or liver enzyme levels
- Elevated serum LDH above normal
- Known central nervous system infiltration
- Anticipated need for MCL therapy within 3 months
- Requirement for vitamin K antagonist anticoagulation
- History of bleeding disorders or recent stroke or brain hemorrhage
- Significant cardiovascular disease or uncontrolled arrhythmias
- Prolonged QT interval above 470 msec
- Positive HIV test or active hepatitis B or C infection
- Active cytomegalovirus infection
- Other recent malignancies except basal skin or in situ cervical cancer
- Recent major surgery or live vaccine administration
- Active uncontrolled autoimmune blood disorders
- Other uncontrolled infections or significant diseases posing risk
- Known allergy to study drugs or components
- Pregnancy or breastfeeding or planning pregnancy during or shortly after study
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 24 cycles (about 24 months)
Participants receive pirtobrutinib in combination with rituximab for at least 24 cycles, each lasting 28 days. Rituximab treatment ends at cycle 23, and pirtobrutinib discontinuation is decided after cycle 24 based on MRD response and TP53 mutational status.
Monthly visits at day 1 of each cycle for up to 24 cycles
Duration - Up to 48 months from treatment start
Participants are monitored for clinical and molecular response duration and survival up to 48 months from the start of treatment.
Periodic visits for assessments up to 48 months
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
A
Ana María Méndez
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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