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An Open-label, Dose Escalation, Phase I Study of IMC-EB10 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Phase 1
18 Years
Not Enrolling
Myeloid Leukemia

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Trial Information

An Open-label, Dose Escalation, Phase I Study of IMC-EB10 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

The purpose of this study is to define the maximum tolerated dose (MTD) and the
pharmacokinetic (PK) profile of the anti-FLT3 monoclonal antibody IMC-EB10, administered
weekly in patients with 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.

Inclusion Criteria:

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

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

3. The patient 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 patient 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 patient has a performance status of 0, 1, or 2 at study entry.

6. The patient is age 18 years or older

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

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

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

10. The patient is able to give written informed consent

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

Exclusion Criteria:

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

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

3. The patient has active central nervous system leukemia

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

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

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

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

8. The patient is receiving chronic steroid or other immunosuppressive medications.
Occasional use of steroid-containing medications, eg, for asthma exacerbation or for
skin lesions, is permitted

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

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

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

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

Type of Study:


Study Design:

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerate Dose (MTD) of IMC-EB10

Outcome Time Frame:

4 weeks

Safety Issue:


Principal Investigator

E-mail: ClinicalTrials@

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC


United States: Food and Drug Administration

Study ID:




Start Date:

June 2009

Completion Date:

August 2010

Related Keywords:

  • Myeloid Leukemia
  • AML
  • Leukemia
  • Acute Myeloid Leukemia
  • Antibodies, Monoclonal
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



ImClone Investigational SiteCleveland, Ohio  44134
ImClone Investigational SiteDallas, Texas  75230