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Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies

Primary Purpose

Hematologic Malignancies

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CAMPATH (alemtuzumab)
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematologic Malignancies focused on measuring CD52 Expressing Hematologic Malignancies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 3, 2005
Last Updated
February 4, 2014
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00113048
Brief Title
Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies
Official Title
A Phase I Study of Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancies
Keywords
CD52 Expressing Hematologic Malignancies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CAMPATH (alemtuzumab)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55806
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies

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