Clinical Trials

TRIAL Closing date Notes
IMPROVE Study: The IMpact of Pausing BTKi therapy and Responsiveness Of Vaccination in blood cancEr patients: a randomised controlled study 22nd June 2023 This clinical trial is for patients with Chronic Lymphocytic Leukaemia (CLL) patients taking either ibrutinib or acalabrutinib (BTKi therapy). The study is running in 11 hospitals across England and Wales and will investigate if pausing ibrutinib or acalabrutinib treatment for 3 weeks around the time of vaccination can improve immunity to COVID-19 for patients. The government has recommended patients to have a COVID-19 vaccine this Spring from 17th April 2023.  For more information about how to take part please refer to https://improve.octru.ox.ac.uk/
GO29781: a phase 1/1b trial testing mosunetuzumab, on its own or with atezolizumab, in people with B-cell non-Hodgkin lymphoma or chronic lymphocytic leukaemia (CLL) that has come back or has not responded to treatment 31 Mar 2021 This is a phase 1 (early phase) trial of an experimental treatment. Little is known about the safety and effectiveness of this treatment. You might not benefit from the treatment, but the trial will give important information about this new treatment, which could help other people in the future.
FLAIR: a randomised phase 3 trial comparing treatments containing ibrutinib with standard first treatment for chronic lymphocytic leukaemia (CLL) 31 Mar 2021 FLAIR Trial: The FLAIR Trial is the current UK trial for patients with CLL needing treatment for the first time. In FLAIR patients are scheduled to stop ibrutinib after 6 years by which time they should be in deep remissions so that we might anticipate a long time before progression.
STATIC Trial is designed to answer the question whether continuous ibrutinib until CLL progression or intermittent treatment with ibrutinib is better. Patients receiving ibrutinib in FLAIR will be eligible to enter STATIC. Sept 2021 (TBC) These patients coming from FLAIR who have been taking ibrutinib for 6 years will have the option of any of the following:

1) Enter STATIC and be randomised to continuous ibrutinib or intermittent ibrutinib (note this is not stopping ibrutinib permanently but pausing ibrutinib – patients will re-start in STATIC at the first sign of their CLL reappearing)

2) Enter STATIC and elect to stay on ibrutinib continuously (individual patient choice)

3) Not enter STATIC and remain off ibrutinib in follow-up in FLAIR (the patient will still remain under regular follow-up with their trials team)

 
TREATT: a phase 3 trial testing tranexamic acid to reduce bleeding after chemotherapy 31 Mar 2021 The aim of this trial is to see if taking a drug called tranexamic acid regularly when platelet counts are low can reduce episodes of bleeding and the need for blood transfusions in people having high-dose chemotherapy.
AZD4573: a phase 1 trial looking at a new treatment for people with relapsed or refractory lymphoma and other blood cancers 31 May 2021 This is a phase 1 (early phase) trial of an experimental treatment. This trial is the first time this treatment has been tested in humans. You might not benefit from the treatment, but the trial will give important information about this new treatment which could help other people in the future.  This is an intensive clinical trial, which means you need to be admitted to the hospital for at least 24 hours every time you have the treatment.
JNJ-64264681: A phase 1 trial of a new targeted treatment called JNJ-64264681 in people with relapsed or refractory B-cell non-Hodgkin lymphoma or chronic lymphocytic leukaemia (CLL) 29 Nov 2021 This is a phase 1 (early phase) trial of an experimental treatment. Little is known about the safety and effectiveness of this treatment. You might not benefit from the treatment, but the trial will give important information about this new treatment, which could help other people in the future.
LOXO: A phase 1/2 trial of a new treatment called LOXO-305 in people with relapsed or refractory chronic lymphocytic leukaemia, small lymphocytic lymphoma or other non-Hodgkin lymphoma 30 Nov 2021 This is a phase 1 (early phase) trial of an experimental treatment. Little is known about the safety and effectiveness of this treatment. You might not benefit from the treatment, but the trial will give important information about this new treatment, which could help other people in the future.
ToTem: a phase 1 trial of donor ‘effector memory’ T cells to improve immune system recovery after donor (allogeneic) stem cell transplants 31 Dec 2021 This is a phase 1 (early phase) trial of an experimental treatment. Little is known about the safety and effectiveness of this treatment. You might not benefit from the treatment, but the trial will give important information about this new treatment, which could help other people in the future.
CCS1477-02: a phase 1/2a study of CCS1477 in blood cancers, including relapsed or refractory non-Hodgkin lymphoma 31 Dec 2021 This is a phase 1 (early phase) trial of an experimental treatment. Little is known about the safety and effectiveness of this treatment. You might not benefit from the treatment, but the trial will give important information about this new treatment, which could help other people in the future.
OxPLoreD: a study to find out more about pre-cancerous blood conditions 30 Jan 2022 This study does not involve any treatment. The researchers will ask participants with some early-stage pre-cancerous blood conditions to donate blood samples and to fill out questionnaires. Some participants will also be asked for a liquid bone marrow sample.
BOOST: studying samples from stem cell transplant donors and recipients to improve transplant success rates and reduce side effects 30 Apr 2022 There is no treatment in this study. You are asked to give blood samples for research.
STELLAR: a phase 2 trial of acalabrutinib in people with Richter syndrome 30 Jul 2022 This trial is testing a targeted drug called acalabrutinib, on its own or with chemotherapy and antibody therapy, in people with Richter syndrome.
BGB-3111-304: a randomised phase 3 trial comparing zanubrutinib with a standard treatment for people with untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) 1 Sept 2022 This trial is testing whether a new targeted drug, zanubrutinib (also called BGB-3111), could improve outcomes compared with a standard chemo-immunotherapy treatment (chemotherapy with antibody therapy) for people with CLL or SLL who have not yet received treatment.

People who are not fit enough to have FCR chemo-immunotherapy might be able to enter this trial.
The AstraZeneca study called PROVENT is focusing on the safety and effectiveness of a long-acting antibody (LAAB) combination called AZD7442, and will test whether the treatment will prevent Covid-19 for up to a year. Following potential exposure to the virus, the study will enrol adults who are at increased risk of inadequate response to vaccination or increased risk of COVID-19 infection. The large-scale phase 3 study, which opened for recruitment this week, will recruit 5,000 people worldwide. While in the UK, with NIHR support, 1,000 participants will be recruited to the study across nine UK sites, in Manchester, London, Plymouth, Southampton, West Yorkshire, Enfield, Rochdale and Preston.
A large European alliance of researchers and medical professionals called ‘HARMONY’ is now running a so-called Delphi study. The study aims to identify the most important outcome measures for CLL research – they call this a ‘core outcome set’. These core outcomes should be used in future studies to decide which outcomes are important, researchers need to get the opinion of various stakeholder groups, try to reach agreement, or ‘consensus’, on the most important outcomes  

 

 

 

 

   A project team from the HARMONY Alliance has developed a list of approximately 60 possible outcomes that they want to ask you about. They created this list after looking at research papers and interviewing healthcare professionals and patient groups. The list has been converted into an online survey. Representatives of the four stakeholder groups are invited to participate in the survey.
A new UK study will seek to understand the immune response to COVID-19 vaccinations in patients with certain immunosuppressed conditions, including cancer.   The OCTAVE study will investigate the effectiveness of COVID-19 vaccines being used in the UK in 2021, in up to 5,000 people within these patient populations. Using a variety of state-of-the-art immune tests performed on blood samples taken before and/or after COVID-19 vaccination, researchers will determine patients’ COVID-19 immune response and therefore the likelihood that vaccines will fully protect these groups from SARS-CoV-2 infection. For this study we are asking participants if they would be willing to have a blood sample taken following their first or second vaccination or to complete a home testing kit which will be sent out in the post. If you would like to take part in this Important study, please contact the study team by email at: haematologyengagement@contacts.bham.ac.uk or call 0121-414-4491 for more information.