2-Chlorodeoxyadenosine and Cytarabine in Patients With Idiopathic Hypereosinophilic Syndrome (HES)

Completed · Phase 2

Conditions studied: Leukemia

In brief

Primary Objectives: 1. To determine the response rate, progression-free survival (PFS) and overall survival of patients who receive 2-CdA + Ara-C. 2. To examine if there is any clonality in the cytokine expression of helper T cells or cytokine receptor expression of eosinophils. 3. To determine the effect of 2-CdA on accumulation of Ara-C triphosphate in eosinophils.

Key facts

Study ID

NCT00483067

Run by

M.D. Anderson Cancer Center

People needed

13

Starts

1998-03-01

Expected to finish

2008-07-01

Last updated by the study team

2012-08-02

Who can join

Age: any, up to 76. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must have diagnosis of idiopathic HES, defined as (1) no recent history of allergic reaction or parasitic infection; (2) sustained (> 6 months) hypereosinophilia (1,500/mm\^3); and (3) signs or symptoms of organ involvement.
• Age less than 76 years old.
• Patient is not pregnant.
• Zubrod performance status < 3.
• Life expectancy is not severely limited by concomitant illness.
• Serum creatinine < 2 mg/dL.
• Serum bilirubin < 2 times upper limit of normal (2 mg/dL).
• Alanine aminotransferase (SGPT) < 2 times upper limit of normal (112 IU/L).
• Participant has completed the informed consent process, understands the investigational nature of the study, agrees to participate, and has signed the informed consent.

You may not qualify if…

• Evidence of chronic active hepatitis or cirrhosis, and > 1 month from prior episode of hepatitis.
• Presence of an active infection.
• HIV positive.
• Has eosinophilic leukemia (defined by presence of clonal cytogenetic abnormalities).
• Recent history of parasite infection.
• Recent history of allergic reaction.

Where it is running

• U.T.M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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