NCT01354392

AZD1152 in Diffuse Large B-cell Lymphoma

A Phase 2 Trial of AZD1152 in Relapsed/Refractory Diffuse Large B-cell Lymphoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Oxford University Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	AZD1152	Up to 6 cycles. Each cycle consists of 800 mg. IV infusion over 96 hrs.

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2011-05-16
• Last updated: 2014-07-02

Locations

2 sites across 1 country: United Kingdom