Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies

NCT ID: NCT00113048

Last Updated: 2014-02-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2005-09-30

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.

Conditions

Hematologic Malignancies

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

CAMPATH (alemtuzumab)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Genzyme Corporation

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Locations

Duluth, Minnesota, United States

Durham, North Carolina, United States

Countries

United States

Other Identifiers

CAM111

Identifier Type: -

Identifier Source: org_study_id