ENRICH Ibrutinib for untreated mantle cell lymphoma

Phase 2

• Conditions: Mantle cell lymphoma (MCL); Cancer; Mantle cell lymphoma (MCL)

• Registration Number: ISRCTN11038174
• Lead Sponsor: niversity Hospitals Plymouth NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-21
• Last Update Posted: 5 August 2024
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Current inclusion criteria as of 18/04/2023:
1. Male/female patients aged 60 years and over
2. Pathologically confirmed MCL, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1
3. Stage II-IV disease, measurable by imaging and requiring treatment in the opinion of the treating clinician
4. No previous treatment for MCL (other than localised radiotherapy or 7-day pulse of steroids for symptom control)
5. Performance status ECOG 0-2
6. Absolute neutrophil count >1.0 x 10(9)/L or platelets >100 x 10(9)/L independent of growth factor support or unless related to lymphoma
7. AST and/or ALT <3xULN
8. Total bilirubin =1.5xULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin
9. Calculated creatinine clearance >30 mL/min
10. Cardiac function sufficient to tolerate either rituximab-CHOP or rituximab-bendamustine chemotherapy
11. Able to give voluntary written informed consent
12. Willingness and ability to take Pneumocystis jiroveci pneumonia prophylaxis

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Previous inclusion criteria:
1. Male/female patients 60 years and over
2. Pathologically confirmed MCL, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1
3. Stage II-IV disease, measurable by imaging and requiring treatment in the opinion of the treating clinician
4. No previous treatment for MCL (other than localised radiotherapy or 7 day pulse of steroids for symptom control)
5. Performance status ECOG 0-2
6. Absolute neutrophil count >1.0x109/L or platelets >100x109 /L independent of growth factor support or unless related to lymphoma
7. AST and/or ALT <3xULN
8. Total bilirubin =1.5xULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin
9. Calculated creatinine clearance >30mL/min
10. Cardiac function sufficient to tolerate 300mg/m2 of doxorubicin. A pre-treatment echocardiogram is not mandated, but recommended in patients considered at higher risk of anthracycline cardiotoxicity
11. Able to give voluntary written informed consent

Exclusion Criteria

Current exclusion criteria as of 18/04/2023:
1. Patients considered fit enough to undergo autologous or allogeneic stem cell transplant as treatment for MCL
2. Known serological positivity for HBV, HCV, HIV
3. Vaccinated with live vaccines within 4 weeks prior to Day 1 of Cycle 1
4. Major surgery within 2 weeks prior to Day 1 of Cycle 1
5. 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)
6. Active systemic infection requiring treatment
7. Male subjects with female partners of childbearing potential who are unwilling to use appropriate contraception methods whilst on study treatment
8. Women who are pregnant or breastfeeding
9. Serious medical or psychiatric illness likely to interfere with participation in this clinical study
10. Concurrent treatment with another investigational agent
11. CNS involvement of MCL

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Previous exclusion criteria:
1. Patients considered fit enough to undergo autologous or allogeneic stem cell transplant as treatment for MCL
2. Known serological positivity for HBV, HCV, HIV
3. Vaccinated with live vaccines within four weeks prior to Day 1 of Cycle 1
4. Major surgery within two weeks prior to Day 1 of Cycle 1
5. 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)
6. Active systemic infection requiring treatment
7. Male subjects with female partners of childbearing potential who are unwilling to use appropriate contraception methods whilst on study treatment (see section 8.4)
8. Women who are pregnant or breastfeeding
9. Serious medical or psychiatric illness likely to interfere with participation in this clinical study
10. Concurrent treatment with another investigational agent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 18/04/2023:<br>Progression-free survival is determined at 2.5 years. 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.<br><br>Previous primary outcome measure:<br>Progression Free Survival is determined at 2.5 years measured as time from randomisation to first documented evidence of disease progressions or death from any cause.