Tissue Collection for Biomarkers Determining Resistance to Ibrutinib

Mantle Cell Lymphoma Clinical Trial

— CLARITY  

Official title:

Clinical Validation of Biomarkers Determining Resistance to BTK Inhibition With Ibrutinib in Mantle Cell Lymphoma & Chronic Lymphocytic Leukaemia - Stage 1

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02267590
• Other study ID #: CCR4187
• Status: Recruiting
• Phase: N/A
• First received: October 8, 2014
• Last updated: October 14, 2014
• Start date: October 2014
• Est. completion date: October 2016

Study information

• Verified date: October 2014
• Source: Royal Marsden NHS Foundation Trust
• Contact: Sunil Iyengar
• Phone: 020 8661 3202
• Email: sunil.iyengar[@]rmh.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

Clinical validation of biomarkers determining resistance to BTK inhibition with Ibrutinib in Mantle Cell Lymphoma and Chronic Lymphocytic Leukaemia Stage 1.

Description:

With the recent FDA approval of Ibrutinib for the management of relapsed/refractory MCL and CLL, we are entering an exciting phase in the management of these conditions. A crucial next step is to validate biomarkers that predict clinical activity of Ibrutinib in order to tailor therapy and maximise benefit to patients. The recently opened named patient supply (NPS) of ibrutinib in the UK provides an excellent window of opportunity for these studies.

The investigators have set up a collaboration with Professor Simon Rule (Plymouth) and Dr George Follows (Cambridge), who are carrying out a prospective data collection study for patients entered on to the NPS. With the help of our collaborators the investigators will be able to identify centres in the NHS for collection of samples. Patients entered on to the NPS will be provided an information sheet and research specific consent form following which samples from consenting patients will be transferred to the Royal Marsden Hospital (RMH) for storage. Samples will be logged and tracked using a secure database. Samples for research will be collected at the same time as routine sampling and therefore no additional sampling will be required. For each patient, consent will be obtained for pretreatment, progression as well as any diagnostic samples taken or stored and patients will require to be on the study for at least 24 months from the start of their treatment. The collection will end 24 months after the last patient commences treatment on the NPS.

Once we have an idea of the number of patient samples we can collect, the second stage of this study will be initiated and will involve molecular screening of samples at RMH for biomarkers of resistance. The data from the molecular studies will then be correlated with the clinical response data from our collaborators for clinical validation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients entered into the Ibrutinib NPS for relapsed refractory MCL and CLL in the UK and who consent to have biological material stored for this research will be included in the study. Patients who have already commenced treatment with Ibrutinib will also be eligible whether or not they are responding.

Exclusion Criteria:

• All samples received will undergo histological (or morphological) review and immunophenotyping. The following samples will be excluded-

1. Samples not satisfying the criteria for diagnosis of CLL or MCL.

2. Samples with evidence of high grade transformation (e.g. Richter's transformation of CLL).

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukaemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

Locations

Country	Name	City	State
United Kingdom	The Royal Marsden NHS Foundation Trust	Sutton	Surrey

Sponsors (3)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust	Cambridge University Hospitals NHS Foundation Trust, Plymouth Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of MCL and CLL patient samples collected, both pre-treatment and at progression.		24 months	No