Posaconazole Prophylaxis During ATG Treatment for hMDS/AA Patients

• Status: Unknown status
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the efficacy of posaconazole as prophylaxis antifungal agent in aplastic anemia / hypoplastic myelodysplastic syndrome (AA/hMDS) patients undergoing antithymocyte globulin (ATG) treatment

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Antifungal Agents; Antilymphocyte Serum; Posaconazole

Criteria

Inclusion Criteria:

1. willing and able to provide written informed consent for voluntary participation in the trial

2. adult patients (≥18 years, <75 years old)

3. no QTc prolongation on initial ECG

4. Adequate organ function for treatment as follows:

A. Absolute neutrophil count > 1.5 x 109/L B. Platelets >100 x 109/L C. Serum creatinine ≤ 2.0 x ULN (upper limit of normal) D. Serum bilirubin ≤ 1.5 x ULN E. AST and ALT ≤ 2.0 x ULN

Exclusion Criteria:

1. those suspected of fungal infection within 30 days of ATG treatment

2. those allergic to -triazoles

3. those with history of malignancies within 5 years and/or concomitant malignancy other than AA/hMDS

4. those with history of chemotherapy, radiotherapy and/or other immunosuppressants

5. female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control

6. active HBV, HCV patients

7. HIV positive patients

8. those with history of receiving organ transplantation