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

Chronic Lymphocytic Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00603668
• Other study ID #: IM-T-hLL1-02
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 2008
• Est. completion date: February 2013

Study information

• Verified date: March 2013
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: February 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Biological:
• milatuzumab
two or three times a week dosing of hLL1 for a total of 4 weeks

Locations

Country	Name	City	State
United States	Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	MD Anderson Cancer Center	Houston	Texas
United States	M. D. Anderson Cancer Center	Orlando	Florida
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	Georgetown University Hospital Lombardi Cancer Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

References & 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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Pharmacokinetics (how the drug is processed by the body)		over the first 12 weeks
Secondary	Pharmacodynamics (how the study drug is absorbed by the body)'		over the first 12 weeks, then over 2 years
Secondary	Immunogenicity		over at least first 12 weeks
Secondary	optimal dose		first 12 weeks