Tissue Collection for Biomarkers Determining Resistance to Ibrutinib (CLARITY)

October 14, 2014 updated by: Royal Marsden NHS Foundation Trust

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

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

Study Overview

Status

Unknown

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The Ibrutinib named patient supply (NPS) was introduced across the NHS for relapsed/ refractory CLL in April this year. Patients with relapsed/ refractory MCL were allowed to enter this programme in September. The NPS for CLL is likely to be open until the 30th of September this year while MCL patients can access Ibrutinib until the end of November. Strict inclusion and exclusion criteria have been set out for the NPS and patients are required to be screened through an online portal prior to entry on to the programme. The NPS provides an excellent window of opportunity to collect patient samples for this study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
MCL: 80-100 samples from 60- 70 patients
Mantle Cell lymphoma patients
CLL: 15-20 samples from 10-15 patients
Chronic lymphocytic leukaemia patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total number of MCL and CLL patient samples collected, both pre-treatment and at progression.
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Collaborators

Cambridge University Hospitals NHS Foundation Trust
University Hospital Plymouth NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

October 8, 2014

First Submitted That Met QC Criteria

October 14, 2014

First Posted (Estimate)

October 17, 2014

Study Record Updates

Last Update Posted (Estimate)

October 17, 2014

Last Update Submitted That Met QC Criteria

October 14, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR4187

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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