Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies

This study has been terminated.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00113048
First received: June 3, 2005
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Hematologic Malignancies
Drug: CAMPATH (alemtuzumab)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies

Resource links provided by NLM:


Further study details as provided by Sanofi:

Estimated Enrollment: 24
Study Start Date: December 2003
Estimated Study Completion Date: September 2005
  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113048

Locations
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
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00113048     History of Changes
Other Study ID Numbers: CAM111
Study First Received: June 3, 2005
Last Updated: February 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
CD52 Expressing Hematologic Malignancies

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Alemtuzumab
Campath 1G
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014