Study of IMC-EB10 in Participant With Leukemia

Stopped early · Phase 1

Conditions studied: Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT00887926

Run by

Eli Lilly and Company

People needed

25

Starts

2009-06-01

Expected to finish

2010-08-01

Last updated by the study team

2022-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The participant has acute myeloid leukemia in the bone marrow or blood that has relapsed with or without a prior complete remission
• The participant is not regarded to be a candidate for a potentially curative, higher priority treatment for acute myeloid leukemia
• 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
• 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
• The participant has an Eastern Cooperative Oncology Group (ECOG)performance status of 0, 1, or 2 at study entry.
• The participant is age 18 years or older
• The participant has a life expectancy of >3 months
• The participant has adequate liver and kidney function, as defined in the entry criteria
• The participant is using an effective contraception (per the institutional standard), if procreative potential exists
• The participant is able to give written informed consent
• The participant is willing and able to comply with study procedures, scheduled visits, and treatment plans

You may not qualify if…

• The participant has had prior allogenic or autologous stem cell transplant within <3 months of the first infusion of IMC-EB10
• The participant has had an organ transplant (nonhematologic) within 3 years of study entry
• The participant has active central nervous system leukemia
• The participant has extramedullary disease without peripheral/and or bone marrow involvement
• 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
• The participant is currently receiving antileukemia therapy. Concurrent treatment with hydroxyurea is permitted
• The participant has uncontrolled intercurrent illness as specified in the study entry criteria
• 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
• 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.]
• The participant is pregnant (confirmed by urine or serum pregnancy test) or breast feeding
• The participant has received treatment with monoclonal antibodies within 6 weeks prior to first infusion of IMC-EB10
• The participant has a history of clinically significant allergic reactions to monoclonal antibodies or other therapeutic proteins

Where it is running

• ImClone Investigational Site — Columbus, Ohio, United States
• ImClone Investigational Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.