Ibrutinib for untreated mantle cell lymphoma

Phase 1

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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-06
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 10

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 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 300mg/m2 of doxorubicin. A pre-treatment echocardiogram is not mandated, but recommended in patients considered at higher risk of anthracycline cardiotoxicity
• 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