Mantle cell lymphoma (MCL) Cancer Mantle cell lymphoma (MCL)
Conditions
Interventions
Current intervention as of 18/04/2023:
Participants are randomly allocated to one of two treatment groups:
Group 1: Participants receive daily ibrutinib in combination with 6 or 8 cycles of rituximab
Sponsors
University Hospitals Plymouth NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 _____ 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 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
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 _____ 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 18/04/2023: 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. Previous primary outcome measure: 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 18/04/2023: 1. Overall survival measured as time from randomisation to date of death from any cause is determined at the end of the study 2. Disease response is formally assessed using by CT scans and bone marrow biopsies at baseline, 12 weeks, 24 weeks and every 6 months thereafter until the end of the study 3. Minimal residual disease (MRD) using flow cytometry at end of study 4. Safety and toxicity based on adverse events graded by Common Terminology Criteria for Adverse Event Reporting (CTCAE) v4.03 throughout participation in the study until 30 days post treatment 5. Quality of Life measured using the EORTC QLQ-30 questionnaire at baseline, mid-treatment, end of treatment and end of maintenance 6. Time to next treatment, to include date treatment begins and class of treatment. This will be measured when each participant commences their next treatment regimen, by recording the class of drug that each participant is given as their next line treatment. _____ Previous secondary outcome measures: 1. Overall Survival measured as time from randomisation to date of death from any cause is determined at the end of the study 2. Disease response is formally assessed using CT scanning at baseline, 12 weeks, 24 weeks and every 6 months thereafter until the end of the study 3. MRD using flow cytometry at 2.5 years [please expand the abbreviation “MRD”] Minimal Residual Disease 4. Safety and toxicity based on adverse events graded by Common Terminology Criteria for Adverse Event Reporting (CTCAE) v4.03 throughout participation in the study until 30 days post treatment 5. Quality of Life measured using the EORTC QLQ-30 questionnaire at baseline, 12 weeks, 24 weeks and 2.5 years 6. Cost of delivery measured by study-specific worksheets during the treatment period 7. Time to next treatment, to include date treatment begins and class of treatment. This will be measured when each participant commences their next treatment regimen, by recor | — |
Countries
Denmark, England, Finland, Norway, Sweden, United Kingdom
Contacts
Public ContactClaire Scully
Outcome results
None listed