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AZD1152 in Diffuse Large B-cell Lymphoma

NCT01354392 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2014-07-02

No results posted yet for this study

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

Interventions

DRUG

AZD1152

Up to 6 cycles. Each cycle consists of 800 mg. IV infusion over 96 hrs.

Sponsors & Collaborators

  • The Christie NHS Foundation Trust

    collaborator OTHER

  • University of Manchester

    collaborator OTHER

  • Early Phase Cancer Research Hub, Oxford

    collaborator UNKNOWN

  • Oxford University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Chris Hatton, MRCPath FRCPath(UK) MRCP FRCP · Oxford Radcliffe NHS Trust & University of Oxford

  • John A Radford, MB, ChB, MRCP, MD, FRCP · University of Manchester, Christie NHS Foundation Trust

  • Graham P Collins, MBBS, MRCP(UK), FRCPath · Oxford Radcliffe NHS Trust, University of Oxford

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01354392 on ClinicalTrials.gov