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Study of CEP-701 in Patients with Acute Myeloid Leukemia (AML) Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Study of CEP-701 in Patients with Acute Myeloid Leukemia (AML) conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Study of CEP-701 in Patients with Acute Myeloid Leukemia (AML) Clinical research trials and Study of CEP-701 in Patients with Acute Myeloid Leukemia (AML) healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Study of CEP-701 in Patients with Acute Myeloid Leukemia (AML). Study of CEP-701 in Patients with Acute Myeloid Leukemia (AML) Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Study of CEP-701 in Patients with Acute Myeloid Leukemia (AML) clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Study of CEP-701 in Patients with Acute Myeloid Leukemia (AML) condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.

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Study of CEP-701 in Patients with Acute Myeloid Leukemia (AML)



Study of CEP-701 in Patients with Acute Myeloid Leukemia (AML)

For Condition: Acute Myeloid Leukemia
Status: Recruiting
Sponsor(s): Cephalon ,
Synopsis: The purpose of the study is to determine whether CEP-701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed acute myeloid leukemia (AML) who achieve a second complete remission (CR).
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion criteria: - cytological confirmation of AML; - relapsed disease following first CR of 1 month to 24 months duration; - confirmation of FLT-3 activating mutation positive status after point of initial relapse; - aged 18 years or older; - life expectancy greater than 3 mos.; - ECOG Performance Status of 0, 1, 2 Exclusion criteria: - bilirubin > 2x ULN; - ALT/AST > 3x ULN; - serum creatinine > 1.5 mg/dL; - untreated or progressive infection; - known CNS involvement with AML; - any prior treatment with FLT-3 inhibitor; - active GI ulceration or bleeding; - patient requires treatment for HIV with protease inhibitors; - use of investigational drug within 30 days of baseline visit
Total Enrollment: 120

Location and Contact Information:

MD Anderson Cancer Center *Recruiting*
Houston,  Texas,  77030
United States
Recruiting Miloslav  Beran 713-792-2248

Indiana Cancer Pavillion *Recruiting*
Indianapolis,  Indiana,  46202
United States
Recruiting Cheryl  Rutledge 317-274-0901

The Mayo Clinic *Recruiting*
Rochester,  Minnesota,  55905
United States
Recruiting Colleen  Irlbeck 507-538-0107

University of Nebraska *Recruiting*
Omaha,  Nebraska,  68198
United States
Recruiting Patricia  Pedersen 402-559-4810

Johns Hopkins *Recruiting*
Baltimore,  Maryland,  21231
United States
Recruiting Doug  Smith 410-614-5068

University of Michigan *Recruiting*
Ann Arbor,  Michigan,  48109
United States
Recruiting Irene  Ryan 734-647-9757


Additional Information:
Study ID Numbers:
  C701a/204/ON/US; 
Study Start Date: October 2003
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079482

Other Acute Myeloid Leukemia Studies:
1. Study of Clofarabine & Cytosine Arabinoside Therapy for Older Adults with Acute Myeloid Leukemia

2. Chemotherapy Plus Bone Marrow Transplantation and Filgrastim in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

3. Bone Marrow Transplantation Plus Cyclophosphamide and Radiation Therapy in Treating Patients With Hematologic Cancer

4. Fluconazole Compared With Voriconazole in Preventing Invasive Fungal Infections in Patients Undergoing Allogeneic Hematopoietic Transplantation

5. Acute Myeloid Leukemia Study

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