Mantle Cell LymphomaCLARITYNCT02267590
Tissue Collection for Biomarkers Determining Resistance to Ibrutinib
An observational study of Mantle Cell Lymphoma and Chronic Lymphocytic Leukaemia, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Clinical validation of biomarkers determining resistance to BTK inhibition with Ibrutinib in Mantle Cell Lymphoma and Chronic Lymphocytic Leukaemia Stage 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mantle Cell Lymphoma, Chronic Lymphocytic Leukaemia
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- All samples received will undergo histological (or morphological) review and immunophenotyping. The following samples will be excluded-
- Samples not satisfying the criteria for diagnosis of CLL or MCL.
- Samples with evidence of high grade transformation (e.g. Richter's transformation of CLL).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
Sunil Iyengar, 020 8661 3202, sunil.iyengar@rmh.nhs.uk
Lorna Smith, 020 8661 3018, lorna.smith2@rmh.nhs.uk
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Lymphoma, Mantle-Cell, Leukemia, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Total number of MCL and CLL patient samples collected, both pre-treatment and at progression.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Plymouth NHS Trust, Cambridge University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267590
- Sponsor's protocol ID
- CCR4187
- Acronym
- CLARITY
- Status last verified
- Oct 2014
- First submitted
- 8 Oct 2014
- Last updated
- 17 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of Biomarkers Determining Resistance to BTK Inhibition With Ibrutinib in Mantle Cell Lymphoma & Chronic Lymphocytic Leukaemia - Stage 1
- ClinicalTrials.gov ID
- NCT02267590
- Acronym / sponsor ID
- CLARITY / CCR4187
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University Hospital Plymouth NHS Trust, Cambridge University Hospitals NHS Foundation Trust
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical validation of biomarkers determining resistance to BTK inhibition with Ibrutinib in Mantle Cell Lymphoma and Chronic Lymphocytic Leukaemia Stage 1.
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 design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCL: 80-100 samples from 60- 70 patients | – | –Mantle Cell lymphoma patients |
| CLL: 15-20 samples from 10-15 patients | – | –Chronic lymphocytic leukaemia patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- All samples received will undergo histological (or morphological) review and immunophenotyping. The following samples will be excluded-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total number of MCL and CLL patient samples collected, both pre-treatment and at progression.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mantle Cell Lymphoma and Chronic Lymphocytic Leukaemia, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sunil Iyengar (020 8661 3202, sunil.iyengar@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of MCL and CLL patient samples collected, both pre-treatment and at progression. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2014.