Study of EB10 in Patients With Leukemia

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Myeloid Leukemia	Biological: IMC-EB10	Phase 1

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	26 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	An Open-label, Dose Escalation, Phase I Study of IMC-EB10 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Study Start Date :	June 2009
Actual Primary Completion Date :	August 2010
Actual Study Completion Date :	August 2010

Arms and Interventions

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Arm

Intervention/treatment

Experimental: IMC-EB10 5 mg/kg; All patients will receive intravenous infusions of IMC-EB10, with the dose depending on which cohort they are enrolled into.

Biological: 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 patients 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. Patients who experience a dose limiting toxicity (DLT) will not receive further IMC-EB10 treatment, but will continue to be followed on the protocol. Patients 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

Outcome Measures

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Primary Outcome Measures :

1. Maximum Tolerate Dose (MTD) of IMC-EB10 [ Time Frame: 4 weeks ]

Secondary Outcome Measures :

1. Pharmacokinetic Profile (PK) of IMC-EB10 [ Time Frame: 4 weeks ]
2. Safety profile of IMC-EB10 [ Time Frame: 4 weeks ]
3. Define a recommended Phase 2 dose (RP2D) [ Time Frame: 4 weeks ]
4. Screen for the development of antibodies against IMC-EB10 [ Time Frame: 4 weeks ]
5. Assess the antileukemic response to IMC-EB 10 as monotherapy [ Time Frame: 4 weeks ]
6. Describe the hematologic response to IMC-EB10 in relation to the FLT3 status [ Time Frame: 4 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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 entry
3. The patient has active central nervous system leukemia
4. The patient has extramedullary disease without peripheral/and or bone marrow involvement
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 criteria
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 feeding
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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Ohio
ImClone Investigational Site
Columbus, Ohio, United States, 43210
United States, Texas
ImClone Investigational Site
Houston, Texas, United States, 77030

Sponsors and Collaborators

ImClone LLC

Investigators

Study Director:	E-mail: ClinicalTrials@ ImClone.com	ImClone LLC

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	ImClone LLC
ClinicalTrials.gov Identifier:	NCT00887926 History of Changes
Other Study ID Numbers:	13959; CP17-0801 ( Other Identifier: ImClone, LLC ); I5C-IE-JEBA ( Other Identifier: Eli Lilly and Company )
First Posted:	April 24, 2009
Last Update Posted:	February 28, 2012
Last Verified:	February 2012

Keywords provided by ImClone LLC:

AML; Leukemia; Acute Myeloid Leukemia; Antibodies, Monoclonal

Additional relevant MeSH terms:

Leukemia; Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms	Antibodies, Monoclonal; Immunologic Factors; Physiological Effects of Drugs