Clinical trial · Interventional
2-Chlorodeoxyadenosine and Cytarabine in Patients With Idiopathic Hypereosinophilic Syndrome (HES)
Phase II Study: 2-Chlorodeoxyadenosine (2-CdA) and Cytarabine (Ara-C) in Idiopathic Hypereosinophilic Syndrome (HES)
NCT00483067CI-TRIAL-00007714completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2-CdA | Drug | Cladribine | ALIAS |
| Ara-C | Drug | Cytarabine | ALIAS |
| G-CSF (Granulocyte colony-stimulating factor) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 2-CdA + Ara-C + G-CSF
- description
- 2-CdA 12 mg/m\^2/day by vein (IV) Continuous Infusion and Ara-C 1 gm/m\^2/day IV for 5 Days with G-CSF 5 mcg/kg/day subcutaneously starting Day 9
- interventionNames
- Drug: 2-CdA
- Drug: Ara-C
- Drug: G-CSF (Granulocyte colony-stimulating factor)
Primary outcomes (1)
- measure
- Patient Outcomes at 6 Weeks
- timeFrame
- Baseline to 6 weeks timepoint (day 42)
- description
- Patient outcomes defined at 6 weeks as Complete Remission (CR), absolute eosinophil count less than 1,500/mm3 and less than 5% of eosinophilic infiltrates in the bone marrow; and PR (partial response) defined as major clinical improvement without meeting the criteria specified for CR including an improvement in performance status to Zubrod's 0 or 1 along with clearance of clinical signs and symptoms of disease that are present at baseline.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 76 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. Age less than 76 years old. 3. Patient is not pregnant. 4. Zubrod performance status \< 3. 5. Life expectancy is not severely limited by concomitant illness. 6. Serum creatinine \< 2 mg/dL. 7. Serum bilirubin \< 2 times upper limit of normal (2 mg/dL). 8. Alanine aminotransferase (SGPT) \< 2 times upper limit of normal (112 IU/L). 9. Participant has completed the informed consent process, understands the investigational nature of the study, agrees to participate, and has signed the informed consent. Exclusion Criteria: 1. Evidence of chronic active hepatitis or cirrhosis, and \> 1 month from prior episode of hepatitis. 2. Presence of an active infection. 3. HIV positive. 4. Has eosinophilic leukemia (defined by presence of clonal cytogenetic abnormalities). 5. Recent history of parasite infection. 6. Recent history of allergic reaction.
References
Publications (0)
Data not yet available
No reference posted for this study.