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A Phase I/II Study of Immunotherapy With Milatuzumab (hLL1) in Patients With Chronic Lymphocytic Leukemia (CLL)

Phase 1/Phase 2
18 Years
Not Enrolling
Chronic Lymphocytic Lymphoma

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Trial Information

A Phase I/II Study of Immunotherapy With Milatuzumab (hLL1) in Patients With Chronic Lymphocytic Leukemia (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.

Inclusion Criteria:

- Histologically confirmed diagnosis of recurrent chronic lymphocytic leukemia (by NCI

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of the anti-CD74 antibody will be evaluated based upon physical examinations, hematology and chemistry laboratory evaluations and toxicity events

Outcome Time Frame:

over first 12 weeks

Safety Issue:


Principal Investigator

William Wegener, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Immunomedics, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

August 2008

Completion Date:

February 2013

Related Keywords:

  • Chronic Lymphocytic Lymphoma
  • CLL
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma



MD Anderson Cancer Center Houston, Texas  77030-4096
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294
Georgetown University Hospital Lombardi Cancer Center Washington, District of Columbia  20007
M. D. Anderson Cancer Center Orlando, Florida  32806