- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00868478
The Humanized Monoclonal Antibody Milatuzumab for Refractory Chronic Lymphocytic Leukemia (CLL)
Phase I-II Trial of the Anti CD74 Monoclonal Antibody-Milatuzumab as a Single Agent in Refractory Chronic Lymphocytic Leukemia
Study Overview
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 this study are to assess response rate to the agent, as well as the safety in CLL, using different doses: Overall response (OR), complete response (CR) and partial response (PR) will be determinate according to the NCI criteria.
The secondary objectives are to determine: duration of response, time to progression, overall survival, and the range of doses in which efficacy is seen and MTD not reached.
This study will be done in parallel with other phase I-II studies conducted by Immunomedics.
The study design will take into account that the high levels of circulating CD74expressing cells in CLL may affect both the acute (although probably not long term) toxicity and the efficacy of the study medication. This could translate to a different MTD and a different cumulative dose of Milatuzumab, needed to achieve response.(either a higher dose or longer treatment period.).
The study will be divided into two treatment phases. In the first phase we aim to address whether the dose of 120 mg/m2 is effective in CLL, and also if it is safe. In the second phase we will assess the safety and possible efficacy of higher doses, in those patients that did not achieve a significant response in the first phase. This will be done by gradual dose escalations, not to exceed 600 mg, or the MTD reached in other studies.
In addition, the study will aim at gaining further understanding of the effect of Milatuzumab on the biological in-vitro function of CLL cells.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Michal Z Haran, MD
- Phone Number: 2383 972-8-9441-211
- Email: haran@clalit.org.il
Study Contact Backup
- Name: Lev Shvidel, MD
- Phone Number: 2383 972-8-944-211
- Email: levsh@clalit.org.il
Study Locations
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-
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Rehovot, Israel, 76100
- Recruiting
- Kaplan Medical Center
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Contact:
- Michal Haran, MD
- Email: haran@clalit.org.il
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Principal Investigator:
- Michal Haran, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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/
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response to treatment
Time Frame: 12 weeks, 24 weeks
|
12 weeks, 24 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michal Haran, MD, Kaplan Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMC-07-0080-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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