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Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies

This study has been terminated.
Information provided by:
Sanofi Identifier:
First received: June 3, 2005
Last updated: February 4, 2014
Last verified: February 2014

June 3, 2005
February 4, 2014
December 2003
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Complete list of historical versions of study NCT00113048 on Archive Site
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Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies
A Phase I Study of Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies
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.
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Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hematologic Malignancies
Drug: CAMPATH (alemtuzumab)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2005
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Medical Monitor, Genzyme Corporation
Genzyme, a Sanofi Company
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Study Director: Medical Monitor Genzyme, a Sanofi Company
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP