Phase I/II Study of Different Doses and Dose Schedules of Milatuzumab (hLL1) in 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: NCT00603668
Recruitment Status : Completed
First Posted : January 29, 2008
Last Update Posted : March 27, 2013
Information provided by (Responsible Party):
Immunomedics, Inc.

Brief Summary:
This study will test different doses of anti-CD74 antibody in patients with NHL and/or CLL.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Lymphoma Biological: milatuzumab Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Immunotherapy With Milatuzumab (hLL1) in Patients With Chronic Lymphocytic Leukemia (CLL)
Study Start Date : August 2008
Actual Primary Completion Date : January 2013
Actual Study Completion Date : February 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. Pharmacokinetics (how the drug is processed by the body) [ Time Frame: over the first 12 weeks ]
  3. Pharmacodynamics (how the study drug is absorbed by the body)` [ Time Frame: over the first 12 weeks, then over 2 years ]
  4. Immunogenicity [ Time Frame: over at least first 12 weeks ]
  5. optimal dose [ Time Frame: first 12 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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.

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): 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.

Responsible Party: Immunomedics, Inc. Identifier: NCT00603668     History of Changes
Other Study ID Numbers: IM-T-hLL1-02
First Posted: January 29, 2008    Key Record Dates
Last Update Posted: March 27, 2013
Last Verified: March 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