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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Kaplan Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Immunomedics, Inc.
Information provided by:
Kaplan Medical Center
ClinicalTrials.gov Identifier:
NCT00868478
First received: March 24, 2009
Last updated: June 1, 2010
Last verified: September 2009
  Purpose

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 Intervention Phase
Chronic Lymphocytic Leukemia
Drug: Milatuzumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Kaplan Medical Center:

Primary Outcome Measures:
  • Response to treatment [ Time Frame: 12 weeks, 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: April 2009
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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/
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868478

Contacts
Contact: Michal Z Haran, MD 972-8-9441-211 ext 2383 haran@clalit.org.il
Contact: Lev Shvidel, MD 972-8-944-211 ext 2383 levsh@clalit.org.il

Locations
Israel
Kaplan Medical Center Recruiting
Rehovot, Israel, 76100
Contact: Michal Haran, MD       haran@clalit.org.il   
Principal Investigator: Michal Haran, MD         
Sponsors and Collaborators
Kaplan Medical Center
Immunomedics, Inc.
Investigators
Principal Investigator: Michal Haran, MD Kaplan Medical Center
  More Information

Publications:
Responsible Party: Dr. Michal Haran, Kaplan Medical Center
ClinicalTrials.gov Identifier: NCT00868478     History of Changes
Other Study ID Numbers: KMC-07-0080-CTIL
Study First Received: March 24, 2009
Last Updated: June 1, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Kaplan Medical Center:
humanized monoclonal antibody

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

ClinicalTrials.gov processed this record on September 16, 2014