Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00113048
Recruitment Status : Terminated
First Posted : June 6, 2005
Last Update Posted : February 5, 2014
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Brief Summary:
This phase I study will involve escalating doses of CAMPATH until the goal dose for the cohort is tolerated. The CAMPATH goal dose will be administered to the patient subcutaneously (SQ) 3 times per week for up to 12 weeks.

Condition or disease Intervention/treatment Phase
Hematologic Malignancies Drug: CAMPATH (alemtuzumab) Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies
Study Start Date : December 2003
Estimated Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Alemtuzumab
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with relapsed or refractory hematologic malignancy. The anticipated patient population are patients with chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma or myeloma
  • Patients with a history of a hematologic malignancy that has previously been shown by flow cytometry or immunophenotyping analysis to express CD52
  • Any chemotherapy, major surgery or irradiation must have been completed at least four (4) weeks before enrollment in this study (6 weeks for mitomycin-C or nitrosourea)
  • Patients have recovered from the acute side effects due to prior therapy
  • Life expectancy of > 3 months
  • World Health Organization (WHO) Performance Status 0-2
  • 18 years of age or older
  • Adequate organ function as defined in the protocol

Exclusion Criteria:

  • Prior therapy with CAMPATH
  • Use of an investigational agent within two (2) weeks prior to study enrollment
  • History of anaphylaxis following exposure to humanized monoclonal antibodies
  • Known human immunodeficiency virus (HIV) positive
  • Prior autologous bone marrow or stem cell transplant if within six (6) months of study entry
  • A history or prior allogenic bone marrow transplant or organ transplant
  • Known, symptomatic central nervous system (CNS) involvement with lymphoma
  • Pregnant or lactating women
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (excluding skin infection, lower urinary tract infection, or oral infection), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00113048

United States, Minnesota
Duluth, Minnesota, United States, 55806
United States, North Carolina
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Genzyme, a Sanofi Company
Study Director: Medical Monitor Genzyme, a Sanofi Company

Additional Information:
Responsible Party: Medical Monitor, Genzyme Corporation Identifier: NCT00113048     History of Changes
Other Study ID Numbers: CAM111
First Posted: June 6, 2005    Key Record Dates
Last Update Posted: February 5, 2014
Last Verified: February 2014

Keywords provided by Sanofi:
CD52 Expressing Hematologic Malignancies

Additional relevant MeSH terms:
Antineoplastic Agents