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

Primary Purpose

Chronic Lymphocytic Lymphoma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

milatuzumab

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Lymphoma focused on measuring CLL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Alabama at Birmingham Comprehensive Cancer Center
Georgetown University Hospital Lombardi Cancer Center
M. D. Anderson Cancer Center
University of Pennsylvania Cancer Center
MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

milatuzumab

Arm Description

different doses of hLL1

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Pharmacokinetics (how the drug is processed by the body)

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

Immunogenicity

optimal dose

Full Information

NCT ID

NCT00603668

First Posted

January 8, 2008

Last Updated

August 12, 2021

Sponsor

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT00603668

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gilead Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Lymphocytic Lymphoma

Keywords

CLL

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

milatuzumab

Arm Type

Experimental

Arm Description

different doses of hLL1

Intervention Type

Biological

Intervention Name(s)

milatuzumab

Other Intervention Name(s)

IMMU-115, hLL1

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

Pharmacokinetics (how the drug is processed by the body)

Time Frame

over the first 12 weeks

Title

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

Time Frame

over the first 12 weeks, then over 2 years

Title

Immunogenicity

Time Frame

over at least first 12 weeks

Title

optimal dose

Time Frame

first 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William Wegener, MD, PhD

Organizational Affiliation

Gilead Sciences

Official's Role

Study Chair

Facility Information:

Facility Name

Alabama at Birmingham Comprehensive Cancer Center

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

Georgetown University Hospital Lombardi Cancer Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

M. D. Anderson Cancer Center

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

University of Pennsylvania Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17875789

Citation

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.

Results Reference

background

PubMed Identifier

15297317

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

Results Reference

background

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

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