Ibrutinib for untreated mantle cell lymphoma

Phase 1

• Conditions: ntreated symptomatic Mantle Cell Lymphoma; MedDRA version: 20.0Level: HLTClassification code 10026798Term: Mantle cell lymphomasSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-000832-13-DK
• Lead Sponsor: niversity Hospitals Plymouth NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-17
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

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 <3xULN
• Total bilirubin =1.5xULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin
• Calculated creatinine clearance >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

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 as defined by the Cheson Criteria 1999. ;Secondary Objective: To evaluate and compare for each treatment group:<br>• Overall survival <br>• Disease response as defined by Cheson 1999<br>• Quality of life measured by the EORTC QLQ-C30 at baseline, during treatments and at the end of maintenance<br>• Cost of delivery using a subset of participants from selected sites<br>• 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 time from the date of randomisation to the date of progression or death from any cause.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Overall survival <br>Disease response<br>Safety and toxicity<br>Quality of life (EORTC QLQ-C30)<br>Cost of delivery<br>Time to next treatment<br>;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.<br>-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) <br>-Safety and toxicity: evaluated throughout the study<br>-Quality of life: at baseline, mid treatment (9-12 weeks), end of treatment (19-25 weeks) and end of maintenance (up to 2.5 years from start of treatment).<br>-Cost of delivery: evaluated during the treatment period only.