Ibrutinib for Mantle cell lymphoma

Inclusion criteria

• {"criterion_text":"- Male/female patients 60 years and over\n- Calculated creatinine clearance >30mL/min\n- Cardiac function sufficient to tolerate either Rituximab-CHOP or Rituximab-Bendamustine chemotherapy\n- Able to give voluntary written informed consent\n- Pathologically confirmed MCL, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1\n- Stage II-IV disease, measurable (>1.5cm) by imaging and requiring treatment in the opinion of the treating clinician\n- No previous treatment for MCL (other than localised radiotherapy or 7 day pulse of steroids for symptom control)\n- Willingness and ability to take Pneumocystis jiroveci Pneumonia prophylaxis\n- Performance status ECOG 0-2\n- Absolute neutrophil count >1.0x10^9/L and platelets >100x10^9/L independent of growth factor support or unless related to Lymphoma\n- AST and/or ALT <3xULN\n- Total bilirubin ≤1.5xULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin"}

Exclusion criteria

• {"criterion_text":"- Patients considered fit enough to undergo autologous or allogeneic stem cell transplant as treatment for MCL\n- Male participants with female partners of childbearing potential who are unwilling to use appropriate contraception methods whilst on study treatment\n- Women who are pregnant or breastfeeding\n- CNS involvement of MCL\n- Known serological positivity for HBV, HCV, HIV\n- Vaccinated with live vaccines within four weeks prior to Day 1 of Cycle 1\n- Major surgery within 2 weeks prior to Day 1 of Cycle 1\n- 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)\n- Active systemic infection requiring treatment\n- Serious medical or psychiatric illness likely to interfere with participation in this clinical study\n- Concurrent treatment with another investigational agent"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is progression-free survival (PFS). 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","definition_or_measurement_approach":"Defined as the interval from the date of randomisation to the earlier of first documentation of disease progression/relapse or death from any cause (i.e. PFS measured from randomisation to progression or death)."}

Secondary endpoints

• {"endpoint_text":"- Overall survival will be measured from the date of randomisation to the date of death from any cause","definition_or_measurement_approach":"Overall survival (OS) measured from randomisation to date of death from any cause."}
• {"endpoint_text":"- Disease response will be assessed in accordance with the International Workshop Standardized Response Criteria for Non-Hodgkin's Lymphoma. Response assessments are to be guided by the Cheson Criteria 1999. Disease response will be formally assessed by CT scans and Bone Marrow biopsies","definition_or_measurement_approach":"Disease response assessed per International Workshop/NHL criteria and Cheson 1999, using CT scans and bone marrow biopsies."}
• {"endpoint_text":"- Safety and toxicity - based on adverse events graded by Common Terminology Criteria for Adverse Event reporting (CTCAE) v4.03 and determined by routine clinical assessment","definition_or_measurement_approach":"Safety/toxicity graded by CTCAE v4.03 and routine clinical assessment of adverse events."}
• {"endpoint_text":"- Quality of life - EORTC QLQ-C30 will be used to measure participant assessed quality of life","definition_or_measurement_approach":"Participant-reported quality of life using the EORTC QLQ-C30 questionnaire at baseline, during treatment and at end of maintenance."}
• {"endpoint_text":"- Time to next MCL treatment is defined as the interval from the date of randomisation to the start date of next MCL treatment or the date of death from any cause","definition_or_measurement_approach":"Measured from randomisation to start date of next MCL treatment or date of death."}

Denmark

Earliest CTIS Part Ii Submission Date

03-09-2024

Latest Decision Or Authorization Date

11-09-2024

Processing Time Days

8

Number Of Sites

4

Number Of Participants

34

Finland

Earliest CTIS Part Ii Submission Date

03-09-2024

Latest Decision Or Authorization Date

12-09-2024

Processing Time Days

9

Number Of Sites

2

Number Of Participants

5

Sweden

Earliest CTIS Part Ii Submission Date

03-09-2024

Latest Decision Or Authorization Date

11-09-2024

Processing Time Days

8

Number Of Sites

8

Number Of Participants

71

Norway

Earliest CTIS Part Ii Submission Date

03-09-2024

Latest Decision Or Authorization Date

12-09-2024

Processing Time Days

9

Number Of Sites

2

Number Of Participants

25

Primary sponsor

Full Name

Region Skane

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden

Third parties

• {"country":"Finland","full_name":"HUS-Yhtymae","duties_or_roles":"Sponsor duties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"Sponsor duties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Norway","full_name":"Oslo University Hospital HF","duties_or_roles":"Sponsor duties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Sweden","full_name":"Croak AB","duties_or_roles":"Sponsor duties code: 1","organisation_type":"Pharmaceutical company"}
• {"country":"Norway","full_name":"St. Olavs Hospital HF","duties_or_roles":"Sponsor duties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}

Co-sponsors

• University Hospitals Plymouth NHS Trust