Ibrutinib for untreated mantle cell lymphoma

Randomised, open label study of rituximab/ibrutinib vs rituximab/chemotherapy in older patients with untreated mantle cell lymphoma - ENRICH Ibrutinib for untreated mantle cell lymphoma

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000832-13-SE

Enrollment

400

Registered

2017-07-04

Start date

2017-08-21

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Untreated symptomatic Mantle Cell Lymphoma MedDRA version: 20.0 Level: HLT Classification code 10026798 Term: Mantle cell lymphomas System Organ Class: 100000004851

Interventions

Trade Name: Ibrutinib Product Name: Ibrutinib Pharmaceutical Form: Capsule, hard INN or Proposed INN: ibrutinib CAS Number: 936563-96-1 Concentration unit: mg milligram(s) Concentration type: equal Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Male/female patients 60 years and over • 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) • Performance status ECOG 0-2 • Absolute neutrophil count >1.0x10*9/L or platelets >100x10*9 /L independent of growth factor support or unless related to lymphoma • AST and/or ALT 30mL/min • Cardiac function sufficient to tolerate either Rituximab-CHOP or Rituximab-Bendamustine chemotherapy • Able to give voluntary written informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 320

Exclusion criteria

Exclusion criteria: • Patients considered fit enough to undergo autologous or allogeneic stem cell transplant as treatment for MCL • Known serological positivity for HBV, HCV, HIV • Major surgery within two weeks prior to Day 1 of Cycle 1 • Diagnosed with or treated for any other malignancy 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 • Male subjects with female partners of childbearing potential who are unwilling to use appropriate contraception methods whilst on study treatment • Women who are pregnant or breastfeeding • Serious medical or psychiatric illness likely to interfere with participation in this clinical study • Concurrent treatment with another investigational agent

Design outcomes

Primary

Measure	Time frame
Main Objective: This study will assess whether ibrutinib given in combination with rituximab is superior to chemotherapy given in combination with rituximab in terms of progression free survival.;Secondary Objective: To evaluate and compare for each treatment group: • Overall survival as defined by Cheson 1999 • Disease response as defined by Cheson 1999 • Minimal residual disease using flow cytometry tests at end of maintenance • Safety and toxicity • Quality of life measured by the EORTC QLQ-C30 at baseline, during treatments and at the end of maintenance • Cost of delivery using a subset of participants from selected sites • Time to next treatment; to include date treatment begins and class of treatment;Primary end point(s): Progression Free Survival ;Timepoint(s) of evaluation of this end point: This is defined as the interval from the date of randomisation to the earlier of the first documentation of disease progression/relapse or death from any cause.	—

Measure

Time frame

Main Objective: This study will assess whether ibrutinib given in combination with rituximab is superior to chemotherapy given in combination with rituximab in terms of progression free survival.;Secondary Objective: To evaluate and compare for each treatment group: • Overall survival as defined by Cheson 1999 • Disease response as defined by Cheson 1999 • Minimal residual disease using flow cytometry tests at end of maintenance • Safety and toxicity • Quality of life measured by the EORTC QLQ-C30 at baseline, during treatments and at the end of maintenance • Cost of delivery using a subset of participants from selected sites • Time to next treatment; to include date treatment begins and class of treatment;Primary end point(s): Progression Free Survival ;Timepoint(s) of evaluation of this end point: This is defined as the interval from the date of randomisation to the earlier of the first documentation of disease progression/relapse or death from any cause.

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Secondary

Measure	Time frame
Secondary end point(s): Overall survival Disease response Safety and toxicity Quality of life (EORTC QLQ-C30) Cost of delivery Time to next MCL treatment ;Timepoint(s) of evaluation of this end point: -Overall survival: time from randomisation to date of death from any cause. Participants not known to have died will be censored at the date they were last known to be alive. -Disease response: assessed midway through treatment period (9-12 weeks post start of treatment), at end of treatment period (19-25 weeks post start of treatment) and then every 6 months until the end of maintenance period (approx 2.5 years post starting treatment). -Safety and toxicity: evaluated throughout the study -Quality of life: at baseline, mid treatment (9-12 weeks), end of treatment (19-25 weeks) and end of maintenance (up to 2.5years). -Cost of delivery: evaluated using during the treatment period only. -Time to next MCL treatm: interval date of rand to start date of next MCL treatment or date of death	—

Measure

Time frame

Secondary end point(s): Overall survival Disease response Safety and toxicity Quality of life (EORTC QLQ-C30) Cost of delivery Time to next MCL treatment ;Timepoint(s) of evaluation of this end point: -Overall survival: time from randomisation to date of death from any cause. Participants not known to have died will be censored at the date they were last known to be alive. -Disease response: assessed midway through treatment period (9-12 weeks post start of treatment), at end of treatment period (19-25 weeks post start of treatment) and then every 6 months until the end of maintenance period (approx 2.5 years post starting treatment). -Safety and toxicity: evaluated throughout the study -Quality of life: at baseline, mid treatment (9-12 weeks), end of treatment (19-25 weeks) and end of maintenance (up to 2.5years). -Cost of delivery: evaluated using during the treatment period only. -Time to next MCL treatm: interval date of rand to start date of next MCL treatment or date of death

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Countries

Denmark, Finland, Norway, Sweden, United Kingdom

Contacts

Public ContactElena Brogden

Peninsula Clinical Trials Unit

enrich@plymouth.ac.uk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026