2024-514275-18-00Active, not recruitingPhase 2/3

ENRICH - Randomised, open label study of Rituximab/Ibrutinib vs Rituximab/Chemotherapy in older patients with untreated mantle cell lymphoma

Source: EU CTIS (euclinicaltrials.eu) · Last updated 22 Sept 2025

Brief summary (registry, in English)

To assess whether IR is superior to R-Chemo in terms of progression-free survival (PFS)

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Patients considered fit enough to undergo autologous or allogeneic stem cell transplant as treatment for MCL
Vaccinated with live vaccines within four weeks prior to Day 1 of Cycle 1
Major surgery within 2 weeks prior to Day 1 of Cycle 1
Diagnosed with or treated for any other malignancy other than MCL within 2 years prior to Day 1 of Cycle 1 (except BCC, SCC or any in situ malignancy)
Concurrent treatment with another investigational agent

Known serological positivity for HBV, HCV, HIV
Active systemic infection requiring treatment
Serious medical or psychiatric illness likely to interfere with participation in this clinical study

Male participants with female partners of childbearing potential who are unwilling to use appropriate contraception methods whilst on study treatment
Women who are pregnant or breastfeeding
CNS involvement of MCL

Male/female patients 60 years and over
Calculated creatinine clearance >30mL/min
Cardiac function sufficient to tolerate either Rituximab-CHOP or Rituximab-Bendamustine chemotherapy
Able to give voluntary written informed consent
Pathologically confirmed MCL, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1
Stage II-IV disease, measurable (>1.5cm) by imaging and requiring treatment in the opinion of the treating clinician
No previous treatment for MCL (other than localised radiotherapy or 7 day pulse of steroids for symptom control)
Willingness and ability to take Pneumocystis jiroveci Pneumonia prophylaxis
Performance status ECOG 0-2
Absolute neutrophil count >1.0x10^9/L and platelets >100x10^9/L independent of growth factor support or unless related to Lymphoma
AST and/or ALT <3xULN
Total bilirubin ≤1.5xULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Sites in registry order. Save your city in your profile to sort them by distance.

Site	City	Country	Site status
Region Midtjylland	Aarhus N	Denmark	Active, not recruiting
Rigshospitalet	Copenhagen Oe	Denmark	Active, not recruiting
Odense University Hospital	Odense C	Denmark	Active, not recruiting
Region Sjaelland	Roskilde	Denmark	Active, not recruiting
HUS-Yhtymae	Helsinki	Finland	Active, not recruiting
Tampere University Hospital	Tampere	Finland	Active, not recruiting
Oslo University Hospital HF	Oslo	Norway	Active, not recruiting
St. Olavs hospital HF	Trondheim	Norway	Active, not recruiting
Sahlgrenska University Hospital-Vaestra Goetalandsregionen	Gothenburg	Sweden	Active, not recruiting
Region Halland	Halmstad	Sweden	Active, not recruiting
Region Oestergoetland	Linkoping	Sweden	Active, not recruiting
Region Norrbotten	Lulea	Sweden	Active, not recruiting
Region Skåne	Malmö	Sweden	Active, not recruiting
Karolinska University Hospital	Solna	Sweden	Active, not recruiting
Region Vaesterbotten	Umea	Sweden	Active, not recruiting
Uppsala University Hospital	Uppsala	Sweden	Active, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.