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

Sponsor:	Immunomedics, Inc.
Information provided by (Responsible Party):	Immunomedics, Inc.
ClinicalTrials.gov Identifier:	NCT00603668

Purpose

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 I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study 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:

MedlinePlus related topics: Acute Lymphocytic Leukemia Chronic Lymphocytic Leukemia Leukemia Lymphoma

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
Pharmacokinetics (how the drug is processed by the body) [ Time Frame: over the first 12 weeks ] [ Designated as safety issue: No ]
Pharmacodynamics (how the study drug is absorbed by the body)` [ Time Frame: over the first 12 weeks, then over 2 years ] [ Designated as safety issue: No ]
Immunogenicity [ Time Frame: over at least first 12 weeks ] [ Designated as safety issue: Yes ]
optimal dose [ Time Frame: first 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	66
Study Start Date:	August 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: multiple doses 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 Milatuzumab 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603668

Contacts

Contact: Anne Johnson

973-605-8200

ajohnson@immunomedics.com

Locations

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

Sponsors and Collaborators

Immunomedics, Inc.

Investigators

Study Chair:

William Wegener, MD, PhD

Immunomedics, Inc.

More Information

Publications:

Stein R, Mattes MJ, Cardillo TM, Hansen HJ, Chang CH, Burton J, Govindan S, Goldenberg DM. CD74: a new candidate target for the immunotherapy of B-cell neoplasms. Clin Cancer Res. 2007 Sep 15;13(18 Pt 2):5556s-5563s. Review.

Stein R, Qu Z, Cardillo TM, Chen S, Rosario A, Horak ID, Hansen HJ, Goldenberg DM. Antiproliferative activity of a humanized anti-CD74 monoclonal antibody, hLL1, on B-cell malignancies. Blood. 2004 Dec 1;104(12):3705-11. Epub 2004 Aug 5.

Responsible Party:	Immunomedics, Inc.
ClinicalTrials.gov Identifier:	NCT00603668 History of Changes
Other Study ID Numbers:	IM-T-hLL1-02
Study First Received:	January 8, 2008
Last Updated:	February 2, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Immunomedics, Inc.:

CLL

Additional relevant MeSH terms:

Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Leukemia, B-Cell
Leukemia
Neoplasms by Histologic Type

Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012