Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies

Hematologic Malignancies Clinical Trial

Official title:

A Phase I Study of Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00113048
• Other study ID #: CAM111
• Status: Terminated
• Phase: Phase 1
• First received: June 3, 2005
• Last updated: February 4, 2014
• Start date: December 2003
• Est. completion date: September 2005

Study information

• Verified date: February 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematologic Malignancies
• Neoplasms

Intervention

Drug:
• CAMPATH (alemtuzumab)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

External Links

•   Link