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Sponsored by: |
Genzyme |
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Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00317642 |
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens.
There is no recommended standard treatment for relapsed or refractory acute myelogenous leukemia in patients older than 59 years. Cytarabine is the most commonly used drug to treat these patients. This study will determine if there is additional benefit by combining clofarabine with cytarabine.
Condition | Intervention | Phase |
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Acute Myelogenous Leukemia |
Drug: clofarabine (IV formulation) and cytarabine Drug: placebo and cytarabine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III Randomized, Double-Blind, Controlled Study Comparing Clofarabine and Cytarabine Versus Cytarabine Alone in Adult Patients 55 Years and Older With Acute Myelogenous Leukemia (AML) Who Have Relapsed or Are Refractory After Receiving up to Two Prior Induction Regimens |
Estimated Enrollment: | 376 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | January 2013 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: clofarabine (IV formulation) and cytarabine
clofarabine (IV formulation) infusion 40mg/m^2 / day and cytarabine IV infusion 1g/m^2/day for up to 3 cycles
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2: Experimental |
Drug: placebo and cytarabine
placebo IV infusion and cytarabine IV infusion 1g/m^2/day for up to 3 cycles
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Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Medical Information | 800-745-4447 | medinfo@genzyme.com |
Contact: Medical Information | 617-252-7832 | medinfo@genzyme.com |
Responsible Party: | Genzyme ( Medical Monitor ) |
Study ID Numbers: | CLO34100405 |
Study First Received: | April 24, 2006 |
Last Updated: | August 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00317642 |
Health Authority: | United States: Food and Drug Administration |
acute myelogenous leukemia acute myeloid leukemia relapsed AML refractory AML |
clofarabine cytarabine CLO341 clolar |
Clofarabine Leukemia Acute myelogenous leukemia Leukemia, Myeloid |
Leukemia, Myeloid, Acute Acute myelocytic leukemia Cytarabine |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents |
Physiological Effects of Drugs Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses |