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Phase II Study of CLOFARABINE in Adult Patients with Refractory or Relapsed Acute Myelogenous Leukemia Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Phase II Study of CLOFARABINE in Adult Patients with Refractory or Relapsed Acute Myelogenous Leukemia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase II Study of CLOFARABINE in Adult Patients with Refractory or Relapsed Acute Myelogenous Leukemia Clinical research trials and Phase II Study of CLOFARABINE in Adult Patients with Refractory or Relapsed Acute Myelogenous Leukemia medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Phase II Study of CLOFARABINE in Adult Patients with Refractory or Relapsed Acute Myelogenous Leukemia. Phase II Study of CLOFARABINE in Adult Patients with Refractory or Relapsed Acute Myelogenous Leukemia Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Phase II Study of CLOFARABINE in Adult Patients with Refractory or Relapsed Acute Myelogenous Leukemia clinical trial. Participants frequently get the best healthcare available for their Phase II Study of CLOFARABINE in Adult Patients with Refractory or Relapsed Acute Myelogenous Leukemia condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase II Study of CLOFARABINE in Adult Patients with Refractory or Relapsed Acute Myelogenous Leukemia  Phase II Study of CLOFARABINE in Adult Patients with Refractory or Relapsed Acute Myelogenous Leukemia
Phase II Study of CLOFARABINE in Adult Patients with Refractory or Relapsed Acute Myelogenous Leukemia
For Condition: Acute Myelogenous Leukemia
Status: Completed
Sponsor(s): ILEX Products ,
Synopsis: This is a single arm, open-label, Phase II study of CLOFARABINE in adult patients with refractory or relapsed acute myelogenous leukemia (AML). Qualified patients must be refractory to one or two induction regimens, or have relapsed < one year from the date of confirmation of the initial complete remission (CR). There will be two phases in this study – an Induction phase and a Consolidation phase.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: For inclusion and exclusion criteria, a regimen is defined as including Induction, Consolidation, and Maintenance therapies.Patients must meet all of the following: - Diagnosis of AML according to FAB classification - Must not be eligible for therapy of higher curative potential, and must be in first or subsequent relapse and/or refractory - A Karnofsky Performance Status (KPS) of greater than or equal to 60. - If female of childbearing potential, patients must have a negative serum or urine pregnancy test within 7 days of study enrollment. Men and women with reproductive potential must use as an effective contraceptive method while enrolled in the study. Patients must have contraceptive and/or fertility counseling prior to entering the study, i.e., information on sperm banking, etc. - Signed, written informed consent. - Ability to comply with study procedures and follow-up examinations. - Adequate organ function as indicated by specific laboratory values (defined in the protocol), obtained within two weeks prior to registration. - Classified as AML FAB M3 (Acute Promyelocytic leukemia) and have been treated with at least 2 regimens (a retinoic acid containing regimen and an arsenic trioxide containing regimen) before being considered for this study. Exclusion Criteria: Patients with or who meet the following will be excluded from study admission: - Received previous treatment with CLOFARABINE. - Received more than two previous induction regimens or cycles for the treatment of AML. - Relapsed > 1 year. - Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment. - Are pregnant or lactating. - Have psychiatric disorders that would interfere with consent, study participation or follow-up. - Are receiving any other chemotherapy or corticosteroids. Patients must be off previous therapy for at least two weeks and must have recovered from acute toxicity of all previous therapy prior to enrollment. - Have any other severe concurrent disease. - Have symptomatic CNS involvement. - Have chronic myelogenous leukemia (CML) in lymphoid blast crisis).
Total Enrollment: 40
Location and Contact Information:
Additional Information:
Study ID Numbers: CLO-221;
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00044889
Other Acute Myelogenous Leukemia Studies:
1. Molecular Epidemiology of Childhood Leukemia in Northern and Central California
2. Therapy of Relapsed AML with Chemotherapy and Dendritic Cell Activated Lymphocytes
3. Study of Gelonin Purging of Autologous Stem Cells for Transplantation
4. Dosing Study of Ara-C/EL625/Idarubicin in Refractory and Relapsed AML
5. Megadose CD34 Selected Progenitor Cells for Transplantation in Patients with Advanced Hematological Malignant Diseases
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Phase II Study of CLOFARABINE in Adult Patients with Refractory or Relapsed Acute Myelogenous Leukemia
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