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

August 12, 2021 updated by: Gilead Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
over first 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
over the first 12 weeks, then over up to 2 years
Pharmacokinetics (how the drug is processed by the body)
Time Frame: over the first 12 weeks
over the first 12 weeks
Pharmacodynamics (how the study drug is absorbed by the body)'
Time Frame: over the first 12 weeks, then over 2 years
over the first 12 weeks, then over 2 years
Immunogenicity
Time Frame: over at least first 12 weeks
over at least first 12 weeks
optimal dose
Time Frame: first 12 weeks
first 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

January 8, 2008

First Submitted That Met QC Criteria

January 16, 2008

First Posted (ESTIMATE)

January 29, 2008

Study Record Updates

Last Update Posted (ACTUAL)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 12, 2021

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM-T-hLL1-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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