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A Single-arm Phase II Study of Alemtuzumab in Combination With High-dose Methylprednisolone in CLL Patients With p53 Deletion


Phase 2
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukaemia

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Trial Information

A Single-arm Phase II Study of Alemtuzumab in Combination With High-dose Methylprednisolone in CLL Patients With p53 Deletion


Inclusion Criteria:



- At least 18 years old

- Written informed consent

- Confirmed diagnosis of CLL or SLL (small mature lymphocytes n blood, bone marrow or
lymph nose expressing CD19, CD5, CD23, weakk CD79b, and weak clonally restricted
immunoglobin light chain)

- p53 deletion by FISH in at least 20% of leukamia cells

- Treatment is indicated (Binet stage B or C, or stage A with a lyphocyte doubling time
of less than 6 months, or disease-related symptoms or complications irrespective of
clinical stage)

- WHO performance status 0, 1 or 2

- Both untreated and previously treated patients are eligible for study

Exclusion Criteria:

- Patients must have none of the following: Active infection Known HIV infection Past
history of anaphylaxis following exposure to rat or mouse CDR-grafted humanised monoclonal
antibodies Less than 3 weeks since prior chemotherapy Use of prior investigational agents
within 6 weeks Pregnancy or lactation Uncontrolled diabetes mellitus Uncontrolled
hypertension Active peptic ulcer disease Other severe concurrent diseases or mental
disorders Serum urea or creatinine more than twice the upper limit of normal (unless due
to uretic obstruction or renal infiltration by CLL/SLL) Serum bilirubin more than twice
the upper limit of normal (unless due to haemlysis or liver infiltration with CLL/SLL)
Persisting severe cytopenias due to previous therapy rather than disease (neutrophils <0.5
x 109/l or platelets <50 x 10/l)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Andrew Pettitt

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Liverpool University Hospital

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

CCR2729

NCT ID:

NCT00292760

Start Date:

Completion Date:

Related Keywords:

  • Chronic Lymphocytic Leukaemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

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