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.

January 8, 2008
January 29, 2008
March 27, 2013
August 2008
January 2013   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00603668 on Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
Phase I/II Study of Different Doses and Dose Schedules of Milatuzumab (hLL1) in CLL
A Phase I/II Study of Immunotherapy With Milatuzumab (hLL1) in Patients With Chronic Lymphocytic Leukemia (CLL)
This study will test different doses of anti-CD74 antibody in patients with NHL and/or CLL.
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.
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Lymphocytic Lymphoma
Biological: milatuzumab
two or three times a week dosing of hLL1 for a total of 4 weeks
Other Names:
  • IMMU-115
  • hLL1
Experimental: milatuzumab
different doses of hLL1
Intervention: Biological: milatuzumab

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2013
January 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Immunomedics, Inc.
Immunomedics, Inc.
Not Provided
Study Chair: William Wegener, MD, PhD Immunomedics, Inc.
Immunomedics, Inc.
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP