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Continuous Infusion of Campath-1H Followed by Subcutaneous Injections in Previously Treated Patients With Chronic Lymphocytic Leukemia
This study has been terminated.
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00102661
  Purpose

The goal of this clinical research study is to learn if giving CAMPATH-1H first as an injection into a vein, then as an injection under the skin can shrink or slow the growth of the disease in patients with chronic lymphocytic leukemia (CLL) who have already received standard therapy. Another goal is to learn if the side effects related to CAMPATH-1H treatment are less severe by giving the drug first as an injection into a vein then as an injection under the skin.


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: Campath-1H
Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Alemtuzumab Campath
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment: 35
Estimated Study Completion Date: October 2006
Detailed Description:

The purposes of this trial are:

  1. To evaluate the response rate (CR+PR) to CAMPATH-1H given as continuous infusion followed by subcutaneous injection in patients with previously treated CLL who have failed fludarabine therapy.
  2. To evaluate whether CAMPATH-1H, given as a continuous infusion followed by subcutaneous injections to patients with previously treated CLL will improve tolerability of the agent and permit higher doses to be delivered through that route.
  3. To evaluate the pharmacokinetics of CAMPATH-1H when given as a 24 hour continuous infusion followed by a subcutaneous injection.
  Eligibility

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

Inclusion Criteria:

  • Age >= 18 years (CLL does not occur in the pediatric population).
  • Signed informed consent.
  • World Health Organization (WHO) performance status of 0, 1, or 2.
  • Patients with B-CLL who have received fludarabine and are either refractory to frontline therapy or have relapsed within six months from receiving fludarabine-based therapy. Patients previously treated with Campath-1H are eligible.
  • Serum creatinine <= 2mg/dL, total bilirubin <= 2mg/dL, and SGPT <= 3x upper limit of normal (ULN) unless due to direct infiltration of the liver or kidney with malignant cells.

Exclusion Criteria:

  • Past history of anaphylaxis, following exposure to rat or mouse derived CDR-grafted humanized monoclonal antibodies.
  • Prior chemotherapy, immunotherapy, or hormonal therapy within 2 weeks prior to study start. Hormonal replacement therapy is permitted. Prior therapy with monoclonal antibodies for at least 4 weeks prior to study start.
  • Pregnant or nursing women or any patient of childbearing age unwilling to practice an acceptable form of contraception.
  • Patients with history of HIV positivity.
  • Active secondary malignancy.
  • Active uncontrolled infection or any major systemic or other illness that would, in the opinion of the investigator, interfere with the patient’s ability to comply with the protocol, compromise patient safety or interfere with the interpretation of study results.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00102661

Locations
United States, Texas
University of Texas- M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Alessandra Ferrajoli, M.D. U.T. M.D. Anderson Cancer Center
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Study ID Numbers: ID02-424
Study First Received: January 31, 2005
Last Updated: January 3, 2007
ClinicalTrials.gov Identifier: NCT00102661  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Chronic lymphocytic leukemia
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Leukemia, Lymphocytic, Chronic, B-Cell
Alemtuzumab
Leukemia, B-cell, chronic
Lymphoproliferative Disorders
Leukemia, B-Cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009