A study to compare an antifungal drug, called VL-2397, with commonly marketed drugs against Invasive Aspergillosis in adults who are immunocompromised

Phase 1

• Conditions: Invasive Aspergillosis; MedDRA version: 20.1 Level: PT Classification code 10051597 Term: Cerebral aspergillosis System Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.1 Level: PT Classification code 10006473 Term: Bronchopulmonary aspergillosis System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]; MedDRA version: 20.0 Level: LLT Classification code 10003490 Term: Aspergillosis pharyngeal System Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.1 Level: LLT Classification code 10022881 Term: Invasive bronchopulmonary aspergillosis System Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0 Level: LLT Classification code 10059259 Term: Pulmonary aspergillosis System Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0 Level: LLT Classification code 10003488 Term: Aspergillosis System Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2017-003435-11-DE
• Lead Sponsor: Vical Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-14
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

For inclusion into the VL2397-201 study, participants must meet all of the following criteria:
1. Male or female (non-pregnant) participants, = age 18 years at the time of consent, and hospitalized at randomization; women of childbearing potential must have a negative serum pregnancy test during screening
2. New diagnosis of possible, probable, or proven pulmonary (or sinopulmonary) IA as defined by the 2008 EORTC/MSG criteria with at least one of the following host factors:
? Acute leukemia (AML or ALL) or other hematological condition (chronic leukemia, myelodysplastic syndrome, multiple myeloma, or aplastic anemia) with severe neutropenia temporally related to the onset of IA
? Allogeneic HCT recipient
? Hematological condition (acute or chronic leukemia, myelodysplastic syndrome, multiple myeloma, or aplastic anemia), lymphoma, solid organ transplant or autologous HCT recipient receiving immunosuppressive therapy. Note: Immunosuppressive therapy is recent use of corticosteroids (at a mean minimum dose of 0.3 mg/kg/day of prednisone or equivalent for > 3 weeks) or other immunosuppressants such as calcineurin inhibitors, TNF-a blockers, T-cell-specific monoclonal antibodies, or nucleoside analogs.
3. Able to provide informed consent and willing to comply with the study requirements
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Potential participants will be excluded from the study if any of the following criteria are met:
1. Respiratory failure on mechanical ventilation
2. Refractory or relapsed leukemia unlikely to respond to reinduction chemotherapy (unless the participant is an allo-HCT recipient)
3. Severe neutropenia (absolute neutrophil count < 500/µL ) for > 10 days that is unlikely to recover during the study
4. Unlikely to survive 30 days after first dose of Study Drug due to graft failure, severe (grade 4) acute graft-versus-host disease (GvHD), refractory chronic GvHD, or other life-threatening condition
5. IA (proven or suspected) involving sites other than lungs and sinuses, including central nervous system (CNS), skin, or liver, and/or disseminated disease
6. Suspected or proven infection with Candida krusei
7. Systemic infection with a bacterial or viral pathogen that is not under control or cannot be treated, or systemic infection with a fungal pathogen other than Aspergillus. Note: Uncomplicated bacteremia, uncomplicated urinary tract infection, and CMV viremia without end organ disease are allowed.
8. Uncontrolled diabetes (given the inherent higher risk for mucormycosis), unless the diagnosis is proven or probable IA
9. Recent episode of acute IA not responding to treatment, chronic aspergillosis, aspergilloma in pre-existing cavity, or allergic aspergillosis
10. Receipt of > 4 cumulative days of systemic antifungal treatment for IA within 7 days prior to study entry. Note: Recent or prior use of a mold-active antifungal for prophylaxis, as determined by the Investigator, is allowed.
11. Hepatic dysfunction, defined as any one of the following: total bilirubin = 3 x the upper limit of normal (ULN), alanine transaminase (ALT) or aspartate transaminase (AST) = 5 x ULN, cirrhosis, or chronic hepatic failure
12. Moderate to severe renal dysfunction defined as any one of the following: creatinine clearance < 50 mL/min at screening, currently on dialysis, or likely to require dialysis during administration of Study Drug
13. Treatment with any investigational drug in a clinical trial within 14 days prior to the first dose of Study Drug
14. Any known or suspected condition of the potential participant that could jeopardize participant adherence to study requirements or impede the accurate assessments of efficacy
15. Males and females of childbearing potential who are unwilling to use highly effective contraceptive methods throughout the study
16. Pregnant or breastfeeding females
17. Alcohol intolerance or dependence (alcoholism)
18. Epilepsy that may be exacerbated by alcohol intake

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified