Status:
UNKNOWN
The Humanized Monoclonal Antibody Milatuzumab for Refractory Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
Kaplan Medical Center
Collaborating Sponsors:
Gilead Sciences
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine whether Milatuzumab is effective in patients with refractory chronic lymphocytic leukemia, and also to find out in which range of doses is a response seen.
Detailed Description
The aim of this study is to determine whether the anti-CD74 monoclonal antibody Milatuzumab provides benefit to subjects with CLL in advanced stage or progressive disease. The primary objectives of th...
Eligibility Criteria
Inclusion
- B-CLL confirmed according to NCI criteria
- CLL relapsed or refractory to prior antineoplastic therapy
- Signs of progressive disease; at least one:
- B symptoms
- lymphocyte doubling time of \< 6 months
- symptomatic lymphadenopathy or splenomegaly
- cytopenias due to bone marrow failure)
- Age \> 18 years, and less then 80
- Serum ALAT, ASAT, bilirubin, creatinine \< 2x upper limit of normal
- Life expectancy \> 6 months
- Patient's written informed consent
Exclusion
- Active bacterial or viral infection
- Hypersensitivity to humanized monoclonal antibodies
- Concurrent antineoplastic treatment for CLL or other malignant disease
- Absolute neutrophil count \< 1.5 K/
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2012
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00868478
Start Date
April 1 2009
End Date
April 1 2012
Last Update
June 2 2010
Active Locations (1)
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1
Kaplan Medical Center
Rehovot, Israel, 76100