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

Phase 1

Completed

• Conditions: Chronic Lymphocytic Lymphoma
• Interventions: Biological: milatuzumab

• Registration Number: NCT00603668
• Lead Sponsor: Gilead Sciences

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2008-01-08
• Study First Submitted QC: 2008-01-16
• Study First Posted: 2008-01-29
• Study Start: 2008-08
• Primary Completion: 2013-01
• Study Completion: 2013-02
• Status Verified: 2013-03
• Disposition First Submitted: 2021-08-12
• Disposition First Submitted QC: 2021-08-12
• Last Update Submitted: 2021-08-12
• Disposition First Posted: 2021-08-16
• Last Update Posted: 2021-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
milatuzumab	milatuzumab	different doses of hLL1

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Pharmacokinetics (how the drug is processed by the body)	over the first 12 weeks
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
Immunogenicity	over at least first 12 weeks
Pharmacodynamics (how the study drug is absorbed by the body)'	over the first 12 weeks, then over 2 years
optimal dose	first 12 weeks

Trial Locations

Locations (5)

M. D. Anderson Cancer Center; 🇺🇸 Orlando, Florida, United States

University of Pennsylvania Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Alabama at Birmingham Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

Georgetown University Hospital Lombardi Cancer Center; 🇺🇸 Washington, District of Columbia, United States