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Phase I/II Study of Different Doses and Dose Schedules of Milatuzumab (hLL1) in CLL

This study has been completed.
Information provided by (Responsible Party):
Immunomedics, Inc. Identifier:
First received: January 8, 2008
Last updated: March 25, 2013
Last verified: March 2013
This study will test different doses of anti-CD74 antibody in patients with NHL and/or CLL.

Condition Intervention Phase
Chronic Lymphocytic Lymphoma
Biological: milatuzumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Immunotherapy With Milatuzumab (hLL1) in Patients With Chronic Lymphocytic Leukemia (CLL)

Resource links provided by NLM:

Further study details as provided by Immunomedics, Inc.:

Primary Outcome Measures:
  • Safety of the anti-CD74 antibody will be evaluated based upon physical examinations, hematology and chemistry laboratory evaluations and toxicity events [ Time Frame: over first 12 weeks ]

Secondary Outcome Measures:
  • Efficacy (to see if the study drug works) in patients with NHL and CLL [ Time Frame: over the first 12 weeks, then over up to 2 years ]
  • Pharmacokinetics (how the drug is processed by the body) [ Time Frame: over the first 12 weeks ]
  • Pharmacodynamics (how the study drug is absorbed by the body)` [ Time Frame: over the first 12 weeks, then over 2 years ]
  • Immunogenicity [ Time Frame: over at least first 12 weeks ]
  • optimal dose [ Time Frame: first 12 weeks ]

Enrollment: 19
Study Start Date: August 2008
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: milatuzumab
different doses of hLL1
Biological: milatuzumab
two or three times a week dosing of hLL1 for a total of 4 weeks
Other Names:
  • IMMU-115
  • hLL1

Detailed Description:
Milatuzumab (hLL1, IMMU-115), a humanized anti-CD74 monoclonal antibody. Dose escalation will utilize 4 planned dose regimens with 4.0 or 8.0 mg/kg doses administered intravenously either twice weekly (days 1 and 4) or thrice weekly (days 1, 3 and 5) for 4 consecutive weeks. The four planned dose regimens will be labeled as dose level 1 to 4 corresponding to increasing levels of the total dose of milatuzumab.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed diagnosis of recurrent chronic lymphocytic leukemia (by NCI criteria)
  • Received at least one prior treatment with standard therapy (previous antibody therapy is acceptable)
  • Measurable disease (WBC > 5,000 for CLL)
  • See protocol for full list

Exclusion Criteria:

  • Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test Pregnancy testing is not required for post-menopausal or surgically sterilized women
  • Women of childbearing potential and fertile men who are not practicing or who are unwilling to practice birth control while enrolled in the study until at least 12 weeks after the last milatuzumab infusion
  • Prior therapy with other human or humanized monoclonal antibodies, unless HAHA tested and negative;
  • Bulky disease by CT, defined as any single mass >10 cm in its greatest diameter
  • Known HIV positive or active hepatitis B or C, or presence of hepatitis B surface antigens or presence of hepatitis C antibody
  • Known autoimmune disease or presence of autoimmune phenomena
  • At least 7 days beyond any infection requiring antibiotic use.
  • Systemic corticosteroids within 2 weeks, except low dose regimens (prednisone, <20 mg/day, or equivalent) which may continue if unchanged.
  • Substance abuse or other concurrent medical or psychiatric conditions that, in the Investigator's opinion, could confound study interpretation or affect the patient's ability to tolerate or complete the study.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00603668

United States, Alabama
Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, District of Columbia
Georgetown University Hospital Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
United States, Florida
M. D. Anderson Cancer Center
Orlando, Florida, United States, 32806
United States, Pennsylvania
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Immunomedics, Inc.
Study Chair: William Wegener, MD, PhD Immunomedics, Inc.
  More Information

Responsible Party: Immunomedics, Inc. Identifier: NCT00603668     History of Changes
Other Study ID Numbers: IM-T-hLL1-02
Study First Received: January 8, 2008
Last Updated: March 25, 2013

Keywords provided by Immunomedics, Inc.:

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases processed this record on April 21, 2017