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ENRICH - Randomised, open label study of Rituximab/Ibrutinib vs Rituximab/Chemotherapy in older patients with untreated mantle cell lymphoma
EU CTIS ID: 2024-514275-18-00
What this study is testing
To assess whether IR is superior to R-Chemo in terms of progression-free survival (PFS)
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Patients considered fit enough to undergo autologous or allogeneic stem cell transplant as treatment for MCL
- 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
- Known serological positivity for HBV, HCV, HIV
- Vaccinated with live vaccines within four weeks prior to Day 1 of Cycle 1
See the full eligibility criteria
- 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
- Patients considered fit enough to undergo autologous or allogeneic stem cell transplant as treatment for MCL
- 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
- Known serological positivity for HBV, HCV, HIV
- 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)
- Active systemic infection requiring treatment
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- Concurrent treatment with another investigational agent
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.