AZD1152 in Diffuse Large B-cell Lymphoma
Diffuse large B-cell lymphoma is the commonest type of aggressive non-Hodgkin's lymphoma, a type of cancer of a cell called a lymphocyte which makes up part of the immune system. Although most patients are cured with chemotherapy used as initial treatment, about 20-30% of patients still experience relapse. Curing relapsed disease is much less successful, even with the use of high doses of chemotherapy and stem cell transplant. There is then an urgent need for effective, new agents to treat patients with diffuse large B-cell lymphoma who have relapsed or who have developed resistance to other forms of chemotherapy.
This trial is using a drug called AZD1152 which interferes with the ability of a cancer cell to divide and grow. It has been used before in patients with other types of cancer, but never before in lymphoma patients. Responses in other cancers have been seen, particularly in leukaemia which is a disease related to lymphoma. The investigators are planning to use this agent in 15 patients with diffuse large B-cell lymphoma in which potentially curative treatments have failed. The main aim is to see whether the drug shows any activity in this type of lymphoma. This will be mainly assessed using CT and PET scans. The investigators are also investigating how well a blood test can predict both the response to the drug and the toxicity of the drug - this is called a biomarker study and forms part of the clinical trial. The other main aim of the study is to assess the toxicity of the treatment. Previous studies in humans suggest the drug is reasonably well tolerated, although side effects such as stomatitis (soreness of the mouth) and suppression of the bone marrow (leading to risk of infection and bleeding) have been seen.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Trial of AZD1152 in Relapsed/Refractory Diffuse Large B-cell Lymphoma|
- Overall response rate (ORR; Cheson 2007 criteria) [ Time Frame: ORR will be calculated from the data obtained from the End Visit, which occurs approx. 14 days after the end of the last cycle of treatment the patient undergoes. ] [ Designated as safety issue: No ]
- Progression free survival at 1 year [ Time Frame: PFS will be calculated at some point 1-year post-study from the available 1 year post-study data. ] [ Designated as safety issue: Yes ]
- Percentage change in tumour size [ Time Frame: Percentage change in tumour size will be calculated from the data obtained from the End Visit, which occurs approx. 14 days after the end of the last cycle of treatment the patient undergoes. ] [ Designated as safety issue: No ]
- Safety of AZD1152 [ Time Frame: The safety of AZD1152 is monitored at every study visit on study via recording AEs/SAEs/SUSARs. However, these are also recorded as they arise. E.g. they would be recorded if the patient had an emergency admissions. ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2011|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Up to 6 cycles. Each cycle consists of 800 mg. IV infusion over 96 hrs.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354392
|Christie NHS Foundation Trust (Christie Hospital)|
|Machester, Lancashire, United Kingdom, M20 4BX|
|Oxford Radcliffe NHS Trust (Cancer & Haematology Centre, Churchill Hospital)|
|Oxford, Oxfordshire, United Kingdom, OX3 7LJ|
|Study Director:||Chris Hatton, MRCPath FRCPath(UK) MRCP FRCP||Oxford Radcliffe NHS Trust & University of Oxford|
|Principal Investigator:||John A Radford, MB, ChB, MRCP, MD, FRCP||University of Manchester, Christie NHS Foundation Trust|
|Principal Investigator:||Graham P Collins, MBBS, MRCP(UK), FRCPath||Oxford Radcliffe NHS Trust, University of Oxford|