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A Study of Clofarabine and Cytarabine for Older Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)(CLASSIC I)

2014-07-23 21:45:14 | BioPortfolio

Summary

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Acute Myelogenous Leukemia

Intervention

clofarabine (IV formulation) and cytarabine, placebo and cytarabine

Location

Mayo Clinical Hospital
Phoenix
Arizona
United States
89081

Status

Active, not recruiting

Source

Genzyme

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:45:14-0400

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Medical and Biotech [MESH] Definitions

A pyrimidine nucleoside analog that is used mainly in the treatment of leukemia, especially acute non-lymphoblastic leukemia. Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA. Its actions are specific for the S phase of the cell cycle. It also has antiviral and immunosuppressant properties. (From Martindale, The Extra Pharmacopoeia, 30th ed, p472)

Congener of CYTARABINE that is metabolized to cytarabine and thereby maintains a more constant antineoplastic action.

A pyrimidine nucleoside formed in the body by the deamination of CYTARABINE.

A triphosphate nucleotide analog which is the biologically active form of CYTARABINE. It inhibits nuclear DNA synthesis.

A rare acute myeloid leukemia characterized by abnormal EOSINOPHILS in the bone marrow.

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