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

NCT00603668 | Completed Phase 1

• 1 other identifier: IM-T-hLL1-02
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Chronic Lymphocytic Lymphoma

Keywords

CLL

Outcome Measures

Primary Outcomes (1)

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

  over first 12 weeks

Secondary Outcomes (5)

• Efficacy (to see if the study drug works) in patients with NHL and CLL

  over the first 12 weeks, then over up to 2 years

• Pharmacokinetics (how the drug is processed by the body)

  over the first 12 weeks

• Pharmacodynamics (how the study drug is absorbed by the body)'

  over the first 12 weeks, then over 2 years

• Immunogenicity

  over at least first 12 weeks

• optimal dose

  first 12 weeks

Study Arms (1)

milatuzumab

EXPERIMENTAL

different doses of hLL1

Biological: milatuzumab

Interventions

milatuzumab BIOLOGICAL

two or three times a week dosing of hLL1 for a total of 4 weeks

Also known as: IMMU-115, hLL1

milatuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (5)

Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Georgetown University Hospital Lombardi Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

M. D. Anderson Cancer Center

Orlando, Florida, 32806, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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. doi: 10.1158/1078-0432.CCR-07-1167.

  PMID: 17875789 BACKGROUND

• 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. doi: 10.1182/blood-2004-03-0890. Epub 2004 Aug 5.

  PMID: 15297317 BACKGROUND

MeSH Terms

Interventions

milatuzumab

Study Officials

• William Wegener, MD, PhD

  Gilead Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2008
• First Posted: January 29, 2008
• Study Start: August 1, 2008
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2013
• Last Updated: August 16, 2021

Record last verified: 2013-03

Locations

US (5)