ENRICH - Randomised, open label study of Rituximab/Ibrutinib vs Rituximab/Chemotherapy in older patients with untreated mantle cell lymphoma
Key facts
- Where
- Gothenburg, Halmstad, Linkoping, Lulea, Malmö, Solna, Umea és Uppsala, SvédországSee the 8 sites
- Phase
- 2/3. fázis
Where in Svédország
- Sahlgrenska University Hospital-Vaestra GoetalandsregionenGothenburg, SvédországNo longer taking part
- Region HallandHalmstad, SvédországNo longer taking part
- Region OestergoetlandLinkoping, SvédországNo longer taking part
- Region NorrbottenLulea, SvédországNo longer taking part
- Region SkåneMalmö, SvédországNo longer taking part
- Karolinska University HospitalSolna, SvédországNo longer taking part
- Region VaesterbottenUmea, SvédországNo longer taking part
- Uppsala University HospitalUppsala, SvédországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Region Skane
- Trial code
- EU 2024-514275-18-00
- Record updated
- 2025. szeptember 22.
- Original description
To assess whether IR is superior to R-Chemo in terms of progression-free survival (PFS)Read full original descriptionShow less
To assess whether IR is superior to R-Chemo in terms of progression-free survival (PFS)
Inclusion: 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.
Exclusion: 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.