Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies

NCT00113048 | Terminated Phase 1

• 1 other identifier: CAM111
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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

Keywords

CD52 Expressing Hematologic Malignancies

Interventions

CAMPATH (alemtuzumab) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older
• Adequate organ function as defined in the protocol

You may not qualify if:

• 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

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (2)

Unknown Facility

Duluth, Minnesota, 55806, United States

Location

Unknown Facility

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Medical Monitor

  Genzyme, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 3, 2005
• First Posted: June 6, 2005
• Study Start: December 1, 2003
• Study Completion: September 1, 2005
• Last Updated: February 5, 2014

Record last verified: 2014-02

Locations

US (2)