Haematology Cancer – Our Trials

Our Trials

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This is a non-interventional study to look at the use of a myeloproliferative neoplasms- symptom assessment form (MPN-SAF) diary in order to assess the patient reported outcomes.

Myeloploliferative neoplasms (MPNs) are associated with a high chance of patients experiencing a range of symptoms affecting many of the body systems. There are few studies that have investigated the effects of standard therapies on symptoms experienced by patients with MPNs.

This study is designed to test the effectiveness of a new questionnaire to collect information about the symptoms experienced by patients with myelopreliferative neoplasms. The questionnaire is in the form of a diary completed by patients. We want to see how well the diary can capture all the information we might need. The study is being organised by the Mayo Clinic in the US.

AML 19 will build upon the results of previous trials in acute myeloid leukaemia. It will evaluate several relevant therapeutic questions in patients who are 18-60 years old and suitable for intensive chemotherapy. For patients who do not have the APL subtype, the investigators will evaluate the best way of adding mylotarg to induction chemotherapy. After induction, patients will be characterised based upon their prognosis and may enter different randomisations, the randomisations allow patients to access different treatments based on their disease profile. The investigators will also evaluate whether continued monitoring of patients can improve outcomes and affects quality of like. Patient with the APL subtype will enter a different part of the trial.

This is a phase III, multicentre, randomized, controlled, open, parallel group trial in patients with previously untreated CLL. A total of 754 participants will be randomized on a 1:1 basis to receive standard therapy with fludarabine, cyclophosphoamide and rituximab (FCR) or ibrutinib plus rituximab (IR)

Background: Chronic Lymphocytic Leukaemia (CLL) is the most common haematological malignancy in the UK. The most effective therapy for treating CLL is the combination of fludarabine, cyclophosphamide and rituximab (FCR). FCR is the standard therapy for patients who are fit for relatively intensive therapy however FCR is associated with significant early and late toxicity mainly with infections and bone marrow suppression. As knowledge of CLL increases new therapies are being developed to treat the disease and the most promising new approach uses therapies that target signalling through the Bcell
receptor (BCR) which is expressed on CLL cells and leads to CLL cell growth.
Bruton’s tyrosine kinase is a critical component of BCR signalling and inhibiting it by use of ibrutinib, a leading agent in the new class of therapies, leads to impressive response rates with minimal toxicity in patients with CLL who have not responded well to previous chemotherapy.

Aims: To assess whether fludarabine (F) and cyclophosphamide (C) in FCR therapy can be replaced by targeted therapy with ibrutinib (I) thereby improving response rates, duration of remission, progressionfree
and overall survival with reduced toxicity, in patients with previously untreated CLL.

The main aim of the study is to compare the effect on progressionfree
survival of IR with that of FCR.

Methods: This is a phase III, multicentre, randomised, controlled, open, parallel group trial in patients with previously untreated CLL comparing IR with the current standard treatment of FCR. The primary research question is to assess
whether IR is superior to FCR in terms of progressionfree survival. Secondary objectives are to assess overall survival, MRD negativity, response rates, safety and toxicity, quality of life and costeffectiveness.

The aim of the project is to develop and validate a quality of life questionnaire designed to assess treatment-related PROs in clinical haematological practice. The study will involve mixed qualitative and quantitative methods of interviews and questionnaires.

The study will be carried out in two main stages. Firstly, data will be collected from interviews and developed into a questionnaire. The second stage of the study will involve validating and piloting the questionnaire in patients with haematological malignancies.

The interviews will last approximately 20-30 minutes and will explore how patients’ lives have been affected by their disease. They will be audio recorded.

The first draft of the questionnaire will be pilot tested in a further cohort of patients. The questionnaire items will then be reduced using statistical techniques on a third cohort, and finally validated. Patients with haematological malignancies will be recruited from outpatient clinics or inpatient settings.

The use of such an investment will allow review of a drug in haematological practice and thereby also permit evaluation of it’s effectiveness.

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