The Humanized Monoclonal Antibody Milatuzumab for Refractory Chronic Lymphocytic Leukemia (CLL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00868478
Recruitment Status : Unknown
Verified September 2009 by Kaplan Medical Center.
Recruitment status was:  Recruiting
First Posted : March 25, 2009
Last Update Posted : June 2, 2010
Immunomedics, Inc.
Information provided by:
Kaplan Medical Center

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.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Milatuzumab Phase 1 Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I-II Trial of the Anti CD74 Monoclonal Antibody-Milatuzumab as a Single Agent in Refractory Chronic Lymphocytic Leukemia
Study Start Date : April 2009
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : April 2012

Intervention Details:
  • Drug: Milatuzumab
    Milatuzumab will be given at a starting dose of 120 mg/m2, and then if no response or significant toxicity is seen after a total of 12 weeks, the dose will be gradually increased, by 120 mg/ m2 every four weeks, for a total of another 12 weeks.
    Other Name: hLL1

Primary Outcome Measures :
  1. Response to treatment [ Time Frame: 12 weeks, 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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/

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00868478

Contact: Michal Z Haran, MD 972-8-9441-211 ext 2383
Contact: Lev Shvidel, MD 972-8-944-211 ext 2383

Kaplan Medical Center Recruiting
Rehovot, Israel, 76100
Contact: Michal Haran, MD   
Principal Investigator: Michal Haran, MD         
Sponsors and Collaborators
Kaplan Medical Center
Immunomedics, Inc.
Principal Investigator: Michal Haran, MD Kaplan Medical Center

Responsible Party: Dr. Michal Haran, Kaplan Medical Center Identifier: NCT00868478     History of Changes
Other Study ID Numbers: KMC-07-0080-CTIL
First Posted: March 25, 2009    Key Record Dates
Last Update Posted: June 2, 2010
Last Verified: September 2009

Keywords provided by Kaplan Medical Center:
humanized monoclonal antibody

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs