Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies
This study has been terminated.
Sponsor:
Genzyme
Information provided by:
Genzyme
ClinicalTrials.gov Identifier:
NCT00113048
First received: June 3, 2005
Last updated: July 28, 2009
Last verified: December 2005
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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 Genzyme:
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
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
Investigators
| Study Director: | Medical Monitor | Genzyme |
More Information
Additional Information:
Related Info 
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: | July 28, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Genzyme:
|
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 May 23, 2013