VL-2397 Compared to Standard First-Line Treatment for Invasive Aspergillosis (IA) in Adults

Sponsor

Vical (Industry)

Overall Status

Terminated

CT.gov ID

NCT03327727

Collaborator

(none)

Enrollment

Locations

Arms

10.8

Actual Duration (Months)

0.1

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the trial is to evaluate the safety and efficacy of a new antifungal with a novel mechanism of action in immunocompromised adults with invasive aspergillosis.

Condition or Disease	Intervention/Treatment	Phase
Invasive Aspergillosis Invasive Pulmonary Aspergillosis	Drug: Investigational Agent: VL-2397 Drug: Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B	Phase 2

Detailed Description

To compare the safety and efficacy of VL-2397 to standard first-line treatment for invasive aspergillosis in immunocompromised adults with acute leukemia or recipients of an allogeneic hematopoietic cell transplant (allo-HCT).

Study Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

The Sponsor, safety monitoring board, and data review committee are masked.

Primary Purpose:

Treatment

Official Title:

A Phase 2 Study of VL-2397 Compared to Standard First-Line Treatment for Invasive Aspergillosis in Adults With Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, or Allogeneic Hematopoietic Cell Transplant Recipients

Actual Study Start Date :

Feb 20, 2018

Actual Primary Completion Date :

Jan 14, 2019

Actual Study Completion Date :

Jan 14, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VL-2397 Investigational agent VL-2397 600 mg IV infusion administered every day for 28 days (4 weeks) followed by 2 weeks of standard treatment	Drug: Investigational Agent: VL-2397 VL-2397 Drug: Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B Voriconazole, Isavuconazole, or Liposomal amphotericin B
Active Comparator: Standard (First-Line) Treatment Investigator selected standard treatments of voriconazole, isavuconazole, or liposomal amphotericin B administered every day for 42 days (6 weeks) per product package insert	Drug: Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B Voriconazole, Isavuconazole, or Liposomal amphotericin B

Arm

Intervention/Treatment

Experimental: VL-2397

Investigational agent VL-2397 600 mg IV infusion administered every day for 28 days (4 weeks) followed by 2 weeks of standard treatment

Drug: Investigational Agent: VL-2397

VL-2397

Drug: Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B

Voriconazole, Isavuconazole, or Liposomal amphotericin B

Active Comparator: Standard (First-Line) Treatment

Investigator selected standard treatments of voriconazole, isavuconazole, or liposomal amphotericin B administered every day for 42 days (6 weeks) per product package insert

Drug: Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B

Voriconazole, Isavuconazole, or Liposomal amphotericin B

Outcome Measures

Primary Outcome Measures

All-cause mortality (ACM) [4 weeks]

Secondary Outcome Measures

ACM [6 weeks]
Number of participants with adverse events [6 weeks]
Number of participants with adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Acute Leukemia (AML or ALL) patient or allo-HCT recipient with a diagnosis of IA

Exclusion Criteria:

Pregnant or breastfeeding
IA involving sites other than lungs and sinuses
Graft failure, acute or extensive chronic GvHD
Uncontrolled diabetes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham Hospital, Division of Infectious Diseases	Birmingham	Alabama	United States	35233
2	UC San Diego Moores Cancer Center	La Jolla	California	United States	92093
3	UC Davis Health, Dept. of Internal Medicine, Div. of Infectious Diseases	Sacramento	California	United States	95817
4	Christiana Care Health Services, Department of Medicine	Newark	Delaware	United States	19718
5	Medical College of Georgia at Augusta University	Augusta	Georgia	United States	30912
6	DMC Harper University Hospital	Detroit	Michigan	United States	48201
7	University of Minnesota, Department of Medicine	Minneapolis	Minnesota	United States	55455
8	Washington University School of Medicine, Division of Infectious Disease	Saint Louis	Missouri	United States	63110
9	The University of Texas Health Science Center, Department of Internal Medicine	Houston	Texas	United States	77030
10	Fred Hutchinson Cancer Research Center (FHCRC)	Seattle	Washington	United States	98109
11	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
12	University Hospital Antwerp (UZA), Department of Hematology	Edegem	Antwerp	Belgium	B-2650
13	General Hospital Saint-Jan, Department of Hematology	Brugge		Belgium	8000
14	Jules Bordet Institute, Department of Infectious Disease	Brussels		Belgium	1000
15	University Hospitals Leuven, Campus Gasthuisberg, Department of Hematology	Leuven		Belgium	3000
16	UCL Mont-Godinne University Hospitals, Department of Hematology	Yvoir		Belgium	B-5530
17	Hamilton Health Sciences, Infectious Disease Research	Hamilton	Ontario	Canada	L8V 1C3
18	Toronto General Hospital	Toronto	Ontario	Canada	M5G 2N2
19	McGill University Health Centre (MUHC), Division of Infectios Diseases	Montréal	Quebec	Canada	H4A 3J1
20	Grenoble University Hospital Center, Department of Hematology	Grenoble		France	38700
21	South Lyon Hospital Center	Pierre-Bénite		France	69310
22	Hautepierre Hospital	Strasbourg		France	67200
23	University Hospital Jena	Jena		Germany	07740
24	Hospital Neuperlach - Municipal Hospital Munich GmbH, Clinic of Hematology and Oncology	Munich		Germany	81737
25	Chonnam National University	Hwasun		Korea, Republic of	519-809
26	Samsung Medical Center	Seoul		Korea, Republic of	06351
27	Seoul National University Hospital	Seoul		Korea, Republic of	11 0-744
28	Asan Medical Center	Seoul		Korea, Republic of	138-736