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

Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT00603668
Collaborator
(none)
19
Enrollment
5
Locations
1
Arm
54
Duration (Months)
3.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: milatuzumab
 Phase 1/Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I/II Study of Immunotherapy With Milatuzumab (hLL1) in Patients With Chronic Lymphocytic Leukemia (CLL)
Study Start Date :
Aug 1, 2008
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Feb 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: milatuzumab

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
  • hLL1

    		•

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. 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]

    2. Pharmacokinetics (how the drug is processed by the body) [over the first 12 weeks]

    3. Pharmacodynamics (how the study drug is absorbed by the body)' [over the first 12 weeks, then over 2 years]

    4. Immunogenicity [over at least first 12 weeks]

    5. optimal dose [first 12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Alabama at Birmingham Comprehensive Cancer Center Birmingham Alabama United States 35294
    2 Georgetown University Hospital Lombardi Cancer Center Washington District of Columbia United States 20007
    3 M. D. Anderson Cancer Center Orlando Florida United States 32806
    4 University of Pennsylvania Cancer Center Philadelphia Pennsylvania United States 19104
    5 MD Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    • Study Chair: William Wegener, MD, PhD, Gilead Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT00603668
    Other Study ID Numbers:
    • IM-T-hLL1-02
    First Posted:
    Jan 29, 2008
    Last Update Posted:
    Aug 16, 2021
    Last Verified:
    Mar 1, 2013
    Keywords provided by Gilead Sciences
    CLL
    Additional relevant MeSH terms:
    Leukemia, Lymphocytic, Chronic, B-Cell

    Study Results

    No Results Posted as of Aug 16, 2021