Posaconazole Prophylaxis During ATG Treatment for hMDS/AA Patients

NCT03318159 | Completed Phase 2 Results

• 1 other identifier: H-1706-207-866
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Aplastic Anemia; Myelodysplastic Syndromes; Fungal Infection

Outcome Measures

Primary Outcomes (1)

• the Incidence of Proven/Probable/Possible Fungal Infection

  Define Invasive fungal infections according to guidelines of the Invasive Fungal Infections Cooperative Group of the European Organization for Research and Treatment of Cancer and Mycoses Study Group of the National Institute of Allergy and Infectious Diseases (Ascioglu S, Rex JH, de Pauw B, et al. Defining opportunistic invasive fungal infections in immunocompromised patients with cancer and hematopoietic stem cell transplants: an international consensus. Clin Infect Dis. 2008;46:1813-1821.

  during 4 weeks of posaconazole prophylaxis (i.e. upto 4 weeks)

Secondary Outcomes (2)

• Overall Survival

  through study completion, an average of 18 months

• Any Incidence of Proven/Probable/Possible Fungal Infection

  through study completion, an average of 18 months

Study Arms (1)

posaconazole prophylaxis group

OTHER

aplastic anemia / hypoplastic myelodysplastic syndrome patients undergoing antithymocyte globulin treatment and receiving posaconazole as prophylaxis antifungal agent

Drug: Posaconazole

Interventions

Posaconazole DRUG

Dosing of posaconazole Posaconazole tablet 300 mg twice daily on day 1; Maintenance dose: 300 mg once daily on day 2 and thereafter. Treatment period: 4 weeks \*if posaconazole tablet intolerance: posaconazole suspension 200mg tid

posaconazole prophylaxis group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• willing and able to provide written informed consent for voluntary participation in the trial
• adult patients (≥18 years, \<75 years old)
• no QTc prolongation on initial ECG
• 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

You may not qualify if:

• those suspected of fungal infection within 30 days of ATG treatment
• those allergic to -triazoles
• those with history of malignancies within 5 years and/or concomitant malignancy other than AA/hMDS
• those with history of chemotherapy, radiotherapy and/or other immunosuppressants
• 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
• active HBV, HCV patients
• HIV positive patients
• those with history of receiving organ transplantation

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Anemia, Aplastic; Myelodysplastic Syndromes; Mycoses

Interventions

posaconazole

Condition Hierarchy (Ancestors)

Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Failure Disorders; Bone Marrow Diseases; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Dr. Koh
• Organization: Seoul National University Hospital

go01@snu.ac.kr

82220727217

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: open label, single arm, phase 2, multicenter \*historical control will be used for comparison: historical control patients are defined as those diagnosed with AA/hMDS and underwent ATG treatment with either fluconazole or itraconazole prophylaxis.

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 23, 2017
• Study Start: April 20, 2018
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: December 20, 2024
• Results First Posted: December 20, 2024

Record last verified: 2024-11

Locations

KR (1)