ISRCTN38006233
Completed
Phase 2
Single-arm phase II to evaluate the safety and efficacy of Campath in combination with high-dose methylprednisolone in CLL patients with deletion of the p53 tumour suppressor gene.
niversity of Liverpool (UK)0 sites40 target enrollmentAugust 19, 2010
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Topic: National Cancer Research Network
- Sponsor
- niversity of Liverpool (UK)
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22493413
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. At least 18 years old, either sex
- •2\. Written informed consent
- •3\. Confirmed diagnosis of CLL or SLL (small mature lymphocytes in blood, bone marrow or lymph node expressing CD19, CD5, CD23, weak CD79b, and weak clonally restricted immunoglobulin light chain)
- •4\. p53 deletion by FISH in at least 20% of leukaemia cells
- •5\. Treatment is indicated (Binet stage B or C, or stage A with a lymphocyte doubling time of less than 6 months, or disease\-related symptoms or complications irrespective of clinical stage)
- •6\. World Health Organization (WHO) performance status 0, 1 or 2
- •7\. Both untreated and previously treated patients are eligible for study
Exclusion Criteria
- •1\. Active infection
- •2\. Known human immunodeficiency virus (HIV) infection
- •3\. Past history of anaphylaxis following exposure to rat or mouse CDR\-grafted humanised monoclonal antibodies
- •4\. Less than 3 weeks since prior chemotherapy
- •5\. Use of prior investigational agents within 6 weeks
- •6\. Pregnancy or lactation
- •7\. Uncontrolled diabetes mellitus
- •8\. Uncontrolled hypertension
- •9\. Active peptic ulcer disease
- •10\. Other severe concurrent diseases or mental disorders
Outcomes
Primary Outcomes
Not specified
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