Study of IMC-EB10 in Participant With Leukemia

NCT ID: NCT00887926

Last Updated: 2022-12-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-08-31

Brief Summary

The purpose of this study is to determine if IMC-EB10 is safe for participants with leukemia, and also to determine the best dose of IMC-EB10 to give to participants.

Detailed Description

The purpose of this study is to define the maximum tolerated dose (MTD) and the pharmacokinetic (PK) profile of the anti-FMS-like tyrosine kinase 3 (FLT3) monoclonal antibody IMC-EB10, administered weekly in participant with acute lymphoblastic leukemia (AML) who have failed to achieve complete remission to a standard induction regimen, relapsed after response to previous antileukemia therapy, or are not eligible for potentially curative or approved salvage options.

Conditions

Myeloid Leukemia

Keywords

AML; Leukemia; Acute Myeloid Leukemia; Antibodies, Monoclonal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IMC-EB10 5 milligrams/kilogram (mg/kg)

All participants will receive intravenous infusions of IMC-EB10, with the dose depending on which cohort they are enrolled into.

Group Type: EXPERIMENTAL

IMC-EB10

Intervention Type: BIOLOGICAL

Cohort 1 will receive IMC-EB10 intravenously for 3 weekly infusions, followed by a 1-week observation period. The starting dose in Cohort 1 will be 5 mg/kg. After all participants in Cohort 1 complete the first cycle of therapy, dose escalation for subsequent cohorts will proceed as follows: Cohort 2 - 10 mg/kg, Cohort 3 - 20 mg/kg, Cohort 4 - 30 mg/kg. Participants who experience a dose-limiting toxicity (DLT) will not receive further IMC-EB10 treatment, but will continue to be followed on the protocol. Participants may continue to receive IMC-EB10 therapy, in the absence of treatment failure, treatment intolerance, or other withdrawal criteria for additional 28-day cycles at the same dose that they initially received. Dosing for Cycle 2 and beyond will be administered on Days 1, 8, 15, and 22 of a 28-day treatment cycle

Interventions

IMC-EB10

Cohort 1 will receive IMC-EB10 intravenously for 3 weekly infusions, followed by a 1-week observation period. The starting dose in Cohort 1 will be 5 mg/kg. After all participants in Cohort 1 complete the first cycle of therapy, dose escalation for subsequent cohorts will proceed as follows: Cohort 2 - 10 mg/kg, Cohort 3 - 20 mg/kg, Cohort 4 - 30 mg/kg. Participants who experience a dose-limiting toxicity (DLT) will not receive further IMC-EB10 treatment, but will continue to be followed on the protocol. Participants may continue to receive IMC-EB10 therapy, in the absence of treatment failure, treatment intolerance, or other withdrawal criteria for additional 28-day cycles at the same dose that they initially received. Dosing for Cycle 2 and beyond will be administered on Days 1, 8, 15, and 22 of a 28-day treatment cycle

Intervention Type: BIOLOGICAL

Other Intervention Names

LY3012218

Eligibility Criteria

Inclusion Criteria

1. The participant has acute myeloid leukemia in the bone marrow or blood that has relapsed with or without a prior complete remission

2. The participant is not regarded to be a candidate for a potentially curative, higher priority treatment for acute myeloid leukemia

3. The participant has resolution of all clinically significant toxic effects of any prior antitumor therapy and any other study-specific clinical or laboratory parameter specified in the entry criteria

4. The participant has not had major surgery, an open biopsy, a significant injury, and/or prior antitumor therapy (except antileukemia therapy) within 21 days prior to the first infusion of IMC-EB10

5. The participant has an Eastern Cooperative Oncology Group (ECOG)performance status of 0, 1, or 2 at study entry.

6. The participant is age 18 years or older

7. The participant has a life expectancy of >3 months

8. The participant has adequate liver and kidney function, as defined in the entry criteria

9. The participant is using an effective contraception (per the institutional standard), if procreative potential exists

10. The participant is able to give written informed consent

11. The participant is willing and able to comply with study procedures, scheduled visits, and treatment plans

Exclusion Criteria

1. The participant has had prior allogenic or autologous stem cell transplant within <3 months of the first infusion of IMC-EB10

2. The participant has had an organ transplant (nonhematologic) within 3 years of study entry

3. The participant has active central nervous system leukemia

4. The participant has extramedullary disease without peripheral/and or bone marrow involvement

5. The participant is disease-free from a previous or concurrent malignancy for a period ≤ 1 year. A participant who has basal cell carcinoma or carcinoma in situ of the cervix will not be excluded from the study

6. The participant is currently receiving antileukemia therapy. Concurrent treatment with hydroxyurea is permitted

7. The participant has uncontrolled intercurrent illness as specified in the study entry criteria

8. The participant is receiving chronic steroid or other immunosuppressive medications. Occasional use of steroid-containing medications for, for example (e.g.), asthma exacerbation or for skin lesions, is permitted

9. The participant is receiving full-dose heparin (including low molecular weight heparin) or warfarin. [The participant is permitted to use low-dose warfarin to maintain patency of preexisting, permanent, indwelling intravenous (I.V.) catheters.]

10. The participant is pregnant (confirmed by urine or serum pregnancy test) or breast feeding

11. The participant has received treatment with monoclonal antibodies within 6 weeks prior to first infusion of IMC-EB10

12. The participant has a history of clinically significant allergic reactions to monoclonal antibodies or other therapeutic proteins

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

E-mail: ClinicalTrials@ ImClone.com

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

ImClone Investigational Site

Columbus, Ohio, United States

ImClone Investigational Site

Houston, Texas, United States

Countries

United States

Other Identifiers

CP17-0801

Identifier Type: OTHER

Identifier Source: secondary_id

I5C-IE-JEBA

Identifier Type: OTHER

Identifier Source: secondary_id

13959

Identifier Type: -

Identifier Source: org_study_id