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A Single-Arm Phase II Study of Alemtuzumab in Combination With High-Dose Methylprednisolone in CLL Patients With p53 Deletion
This study is not yet open for participant recruitment.
Verified by Royal Marsden NHS Foundation Trust, August 2005
First Received: February 15, 2006   Last Updated: October 12, 2006   History of Changes
Sponsored by: Royal Marsden NHS Foundation Trust
Information provided by: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00292760
  Purpose

This is a phase II open label study for patients with p53-deleted CLL who require treatment. Both untreated and previously treated patients are eligible for study entry. The trial consists of giving continuous alemtuzumab and cyclical high-dose methyl-prednisone.Alentuzumab is given intravenously during the first 4 weeks of treatment to ensure that adequate serum levels are achieved quickly. The drug will be administered daily during the first week, commencing at a dose of 3mg, and increasing to 10mg and then up to the target dose of 30mg as tolerated.Thereafter alemtuzumab will be given at a dose 30mg thrice weekly.

From week 5, alemtuzumab will be given at the same dose but by the subcutaneous route of administration.

Methlyprednisolone will be given for 5 consecutive days at a daily dose of 1.0g/m2, starting on Day 1 and repeating the cycle every 28 days.

Treatment will be given for 16 weeks (i.e 4 cycles of methylprednisolone). Treatment will be discontinued if there is no response after 8 weeks, or if toxicity becomes unacceptable.


Condition Intervention Phase
Chronic Lymphocytic Leukaemia
Drug: Alemtuzumab
Drug: Methyprednisolone
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Single-Arm Phase II Study of Alemtuzumab in Combination With High-Dose Methylprednisolone in CLL Patients With p53 Deletion

Resource links provided by NLM:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00292760

Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: Andrew Pettitt Royal Liverpool University Hospital
  More Information

No publications provided

Study ID Numbers: CCR2729, UKCLL 06 (CAM-PRED)
Study First Received: February 15, 2006
Last Updated: October 12, 2006
ClinicalTrials.gov Identifier: NCT00292760     History of Changes
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:
Anti-Inflammatory Agents
Leukemia, Lymphoid
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Methylprednisolone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Methylprednisolone acetate
Prednisolone acetate
Hormones
Glucocorticoids
Neuroprotective Agents
Leukemia
Lymphatic Diseases
Chronic Lymphocytic Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Alemtuzumab
Prednisolone
Peripheral Nervous System Agents
Leukemia, B-Cell
Lymphoproliferative Disorders
Leukemia, B-cell, Chronic
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Leukemia, Lymphoid
Antineoplastic Agents
Methylprednisolone
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Prednisolone acetate
Hormones
Neuroprotective Agents
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Alemtuzumab
Therapeutic Uses
Methylprednisolone Hemisuccinate
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Gastrointestinal Agents
Methylprednisolone acetate
Glucocorticoids
Protective Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Autonomic Agents
Prednisolone
Peripheral Nervous System Agents
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on July 02, 2009