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History of Changes for Study: NCT04368559
Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (ReSPECT)
Latest version (submitted May 3, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 27, 2020 None (earliest Version on record)
2 May 13, 2020 Recruitment Status, Study Status and Contacts/Locations
3 June 4, 2020 Study Status
4 September 11, 2020 Study Status and Contacts/Locations
5 September 22, 2020 Contacts/Locations and Study Status
6 October 2, 2020 Study Status and Contacts/Locations
7 October 30, 2020 Contacts/Locations and Study Status
8 November 6, 2020 Study Status and Contacts/Locations
9 January 4, 2021 Contacts/Locations and Study Status
10 January 22, 2021 Contacts/Locations and Study Status
11 April 26, 2021 Contacts/Locations and Study Status
12 July 15, 2021 Contacts/Locations and Study Status
13 August 26, 2021 Study Status and Contacts/Locations
14 December 10, 2021 Contacts/Locations and Study Status
15 January 20, 2022 Study Status and Contacts/Locations
16 December 23, 2022 Contacts/Locations, Study Status, Outcome Measures, Eligibility, Arms and Interventions, Conditions, Oversight and Study Identification
17 January 5, 2023 Contacts/Locations and Study Status
18 February 7, 2023 Study Status and Contacts/Locations
19 April 14, 2023 Study Status, Contacts/Locations and Eligibility
20 April 26, 2023 Contacts/Locations and Study Status
21 June 6, 2023 Study Status and Contacts/Locations
22 June 19, 2023 Contacts/Locations and Study Status
23 August 28, 2023 Study Status and Contacts/Locations
24 September 1, 2023 Contacts/Locations and Study Status
25 September 16, 2023 Contacts/Locations and Study Status
26 October 4, 2023 Contacts/Locations and Study Status
27 October 12, 2023 Contacts/Locations and Study Status
28 October 16, 2023 Contacts/Locations and Study Status
29 November 27, 2023 Study Status and Contacts/Locations
30 December 5, 2023 Contacts/Locations and Study Status
31 January 17, 2024 Contacts/Locations and Study Status
32 March 7, 2024 Contacts/Locations and Study Status
33 March 8, 2024 Contacts/Locations and Study Status
34 March 22, 2024 Contacts/Locations and Study Status
35 May 3, 2024 Study Status and Contacts/Locations
Comparison Format:

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Changes (Merged) for Study: NCT04368559
April 27, 2020 (v1) -- January 17, 2024 (v31)

Changes in: Study Identification, Study Status, Oversight, Conditions, Arms and Interventions, Outcome Measures, Eligibility and Contacts/Locations

Open or close this module Study Identification
Unique Protocol ID: CD101.IV.3.08
Brief Title: Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (ReSPECT)
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind Study of the Efficacy and Safety of Rezafungin for Injection Versus the Standard Antimicrobial Regimen to Prevent Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (The ReSPECT Study)
Secondary IDs: 2017-004981-85 [EudraCT Number]
Open or close this module Study Status
Record Verification: April 2020 January 2024
Overall Status: Not yet recruiting Recruiting
Study Start: May 11, 2020
Primary Completion: March 2022 August 2024 [Anticipated]
Study Completion: March 2022 August 2024 [Anticipated]
First Submitted: April 22, 2020
First Submitted that
Met QC Criteria:
April 27, 2020
First Posted: April 30, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
April 27, 2020 January 17, 2024
Last Update Posted: April 30 January 18, 2020 2024 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Cidara Therapeutics Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the prevention of invasive fungal diseases when compared to the standard antimicrobial regimen.
Detailed Description: A Phase 3, multicenter, prospective, randomized, double-blind, efficacy and safety study of Rezafungin for injection versus the standard antimicrobial regimen for the prevention of invasive fungal diseases in subjects undergoing allogeneic blood and marrow transplantation.
Open or close this module Conditions
Conditions: Candidemia
Mycoses
Fungal Infection
Fungemia
Invasive Candidiasis
Pneumocystis
Mold Infection
Invasive Fungal Disease
Prophylaxis of Invasive Fungal Infections
Aspergillus
Keywords: Mycoses
Prophylaxis of Invasive Fungal Infections
Aspergillus
Candidiasis
Candidemia
Candidiasis, Invasive
Fungemia
Sepsis
Blood and Marrow Transplant (BMT)
Infection
Invasive Fungal Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Fluconazole
Posaconazole
Caspofungin
Trimethoprim-sulfamethoxazole (TMP/SMX)
Echinocandins
Antifungal Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Pneumocystis
Mold Infection
Rezafungin
Anti-Infective Agents
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 462 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Group 1: Rezafungin for Injection
Subjects in Rezafungin treatment group will receive a 400 mg loading dose in Week 1, followed by 200 mg once weekly, for a total of 13 weeks. Subjects will receive oral placebo for standard antimicrobial regimen (SAR) azole prophylaxis and oral placebo for SAR anti- PCP Pneumocystis pneumonia (PCP) prophylaxis in accordance with the respective SAR dosing regimens for each. For subjects who are switched to a SAR IV regimen, oral placebo for SAR azole prophylaxis will be changed to IV placebo. There is no IV option for SAR anti-PCP prophylaxis.
Drug: Rezafungin for Injection
Intravenous antifungal therapy
Other Names:
  • Intravenous antifungal therapy
Drug: Intravenous Placebo
Normal saline
Other Names:
  • Placebo Infusion
Drug: Oral Placebo
Microcrystalline cellulose
Other Names:
  • encapsulated cellulose
Active Comparator: Group 2: Oral Antifungal
Subjects in SAR treatment group will receive 400 mg oral fluconazole once daily for 13 weeks. Fluconazole may be switched, due to acute clinically significant graft versus-host disease (GVHD), to 300 mg oral posaconazole twice daily on the first day of the medication switch and 300 mg once daily, thereafter. However, subjects who are switched to posaconazole cannot be switched back to fluconazole. Azole-based antifungal therapy (fluconazole or posaconazole) can be switched from daily oral therapy to daily IV therapy at the discretion of the Investigator. In addition, subjects in the SAR group will receive anti-PCP prophylaxis with oral TMP/SMX (80 mg TMP/400 mg SMX) once daily. There is no IV option for SAR anti-PCP prophylaxis.
Drug: Posaconazole
Oral antifungal therapy
Other Names:
  • Noxafil
Drug: Fluconazole
Oral antifungal therapy
Other Names:
  • Generic Fluconazole
Drug: Trimethoprim-sulfamethoxazole (TMP/SMX)
Oral antibacterial therapy
Other Names:
  • Bactrim
  • Septra
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Noninferior Fungal-Free Survival (US FDA)
[ Time Frame: Day 90 (±7 days) ]

The number of subjects in each treatment group who are fungal-free and survive.
2. Noninferior Fungal-Free Survival (US FDA)
[ Time Frame: Day 90 (±7 days) ]

The percentage of subjects in each treatment group who are fungal-free and survive.
3. Superior Fungal-Free Survival (EMA)
[ Time Frame: Day 90 (±7 days) ]

The number of subjects in each treatment group who are fungal-free and survive.
4. Superior Fungal-Free Survival (EMA)
[ Time Frame: Day 90 (±7 days) ]

The percentage of subjects in each treatment group who are fungal-free and survive.
Secondary Outcome Measures:
1. Compare Discontinuation for Toxicity or Intolerance
[ Time Frame: Day 90 (±7 days) ]

The number of subjects that discontinued Rezafungin for Injection compared to the standard antimicrobial regimen (SAR) secondary to toxicity or intolerance.
2. Compare Discontinuation for Toxicity or Intolerance
[ Time Frame: Day 90 (±7 days) ]

The percentage of subjects that discontinued Rezafungin for Injection compared to the standard antimicrobial regimen (SAR) secondary to toxicity or intolerance.
3. Compare Proven and Probable IFD
[ Time Frame: Day 90 (±7 days) ]

The number of subjects in each treatment group who have proven and probable IFD including the number of invasive infections from Candida spp., Aspergillus spp., and Pneumocystis jirovecii.
4. Compare Proven and Probable IFD
[ Time Frame: Day 90 (±7 days) ]

The percentage of subjects in each treatment group who have proven and probable IFD including the number of invasive infections from Candida spp., Aspergillus spp., and Pneumocystis jirovecii.
5. Compare Fungal-Free Survival with or without a Diagnosis of Clinically Significant GVHD
[ Time Frame: Day 90 (±7 days) ]

The number of subjects in each treatment group who are fungal-free survival with or without a diagnosis of clinically significant GVHD.
6. Compare Fungal-Free Survival with or without a Diagnosis of Clinically Significant GVHD
[ Time Frame: Day 90 (±7 days) ]

The percentage of subjects in each treatment group who are fungal-free survival with or without a diagnosis of clinically significant GVHD.
7. Compare Time to IFD, or Death
[ Time Frame: Day 90 (±7 days) ]

Evaluate time to IFD (proven or probable IFD) or death in subjects randomized to Rezafungin for Injection compared to the standard antimicrobial regimen (SAR).
8. Compare Mortality
[ Time Frame: Day 1 through follow-up visit (Day 120) ]

Evaluate overall mortality and attributable mortality, with and without adjustment for patient comorbidity indices, in subjects randomized to Rezafungin for Injection compared to the SAR.
9. Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]
[ Time Frame: Day 1 through follow-up visit (Day 120) ]

The number of subjects with incidence of treatment emergent adverse events based on clinical chemistry, hematology and urine analysis laboratory test, vital sign, physical exams and ECG abnormalities.
10 . Comparison of Fungal-Free
[ Time Frame: Day 14 (±1 day), Day 28 (±1 day), Day 60 (±5 days), and Day 120 (±7 days) ]

The number of subjects in each treatment group who are fungal-free.
11 . Comparison of Fungal-Free
[ Time Frame: Day 14 (±1 day), Day 28 (±1 day), Day 60 (±5 days), and Day 120 (±7 days) ]

The percentage of subjects in each treatment group who are fungal-free.
12 . Comparison of Presence and Severity of GHVD
[ Time Frame: Day 90 (±7 days) ]

Evaluate the presence and severity of GVHD in subjects randomized to Rezafungin for Injection compared to the SAR.
13 . Comparison of Fungal-Free with AML
[ Time Frame: Day 90 (±7 days) ]

The number of subjects in each treatment group who are fungal-free with an underlying diagnosis of acute myeloid leukemia (AML).
14 . Comparison of Fungal-Free with AML
[ Time Frame: Day 90 (±7 days) ]

The percentage of subjects in each treatment group who are fungal-free with an underlying diagnosis of acute myeloid leukemia (AML).
15 . Compare Incidence of IFD
[ Time Frame: Day 14 (±1 day), Day 28 (±1 day), Day 60 (±5 days), Day 90 (±7 days), and Day 120 (±7 days) ]

Evaluate the incidence of proven, probable, possible, and presumptive IFD in subjects randomized to Rezafungin for Injection compared to the SAR.
16 . Compare Relapse-Free Survival
[ Time Frame: Day 1 through follow-up visit (Day 120) ]

Evaluate relapse-free survival, with and without adjustment for patient comorbidity indices, in subjects randomized to Rezafungin for Injection compared to the SAR.
17 . Evaluate PK (Cmax)
[ Time Frame: Day 0 (±2 days) within 10 minutes before end of infusion, and one sample between end of infusion and 12 hours after end of infusion; Days 1-4, one sample at any time; Day 7 (±1 day), Day 28 (±1 day), and Day 63 (±1 day) prior to dosing; and EOT visit ]

Evaluate maximum plasma concentration (Cmax).
18 . Evaluate PK (Tmax)
[ Time Frame: Day 0 (±2 days) within 10 minutes before end of infusion, and one sample between end of infusion and 12 hours after end of infusion; Days 1-4, one sample at any time; Day 7 (±1 day), Day 28 (±1 day), and Day 63 (±1 day) prior to dosing; and EOT visit ]

Evaluate time to Cmax.
19 . Evaluate PK (AUC)
[ Time Frame: Day 0 (±2 days) within 10 minutes before end of infusion, and one sample between end of infusion and 12 hours after end of infusion; Days 1-4, one sample at any time; Day 7 (±1 day), Day 28 (±1 day), and Day 63 (±1 day) prior to dosing; and EOT visit ]

Evaluate area under the curve (AUC).
20 . Compare Post-Engraftment Cytopenias and Transfusion Requirements
[ Time Frame: Day 1 through follow-up visit (Day 120) ]

Evaluate post-engraftment cytopenias and transfusion requirements of Rezafungin for Injection compared to the SAR.
21 . Compare Infections Caused by TMP/SMX-Sensitive Organisms
[ Time Frame: Day 14 (±1 day), Day 28 (±1 day), Day 60 (±5 days), Day 90 (±7 days), and Day 120 (±7 days) ]

Evaluate infections caused by TMP/SMX-sensitive organisms (Toxoplasma gondii [T. gondii], Nocardia spp.) in Rezafungin for Injection compared to the SAR.
22 . Compare Antifungal Prophylaxis
[ Time Frame: Day 14 (±1 day), Day 28 (±1 day), Day 60 (±5 days), Day 90 (±7 days), and Day 120 (±7 days) ]

Evaluate interruption and discontinuation of antifungal prophylaxis due to suspected IFDs of Rezafungin for Injection compared to the SAR.
23 . Compare the health economics outcome research (HEOR) variable of "Days in Hospital"
[ Time Frame: Once weekly for outpatient, or twice weekly for inpatient, at completion of study drug therapy [Day 90 (±7 days)] and for 30 days [Day 120 (±7 days)] ]

Evaluate the number of hospital days for subjects randomized to Rezafungin for Injection compared to the SAR.
24 . Compare the health economics outcome research (HEOR) variable of "Days in Intensive Care Unit (ICU)"
[ Time Frame: Once weekly for outpatient, or twice weekly for inpatient, at completion of study drug therapy [Day 90 (±7 days)] and for 30 days [Day 120 (±7 days)] ]

Evaluate the number of days in ICU for subjects randomized to Rezafungin for Injection compared to the SAR.
25 . Compare the health economics outcome research (HEOR) variable of "Readmission due to Infectious Disease Diagnosis"
[ Time Frame: Once weekly for outpatient, or twice weekly for inpatient, at completion of study drug therapy [Day 90 (±7 days)] and for 30 days [Day 120 (±7 days)] ]

Evaluate readmission(s) due to infectious disease diagnosis for subjects randomized to Rezafungin for Injection compared to the SAR.
26 . Compare the health economics outcome research (HEOR) variable of "Readmission due to Invasive Fungal Disease Diagnosis"
[ Time Frame: Once weekly for outpatient, or twice weekly for inpatient, at completion of study drug therapy [Day 90 (±7 days)] and for 30 days [Day 120 (±7 days)] ]

Evaluate readmission(s) due to invasive fungal disease diagnosis for subjects randomized to Rezafungin for Injection compared to the SAR.
27 . Compare the health economics outcome research (HEOR) variable of "Alternative Antifungal Therapy"
[ Time Frame: Once weekly for outpatient, or twice weekly for inpatient, at completion of study drug therapy [Day 90 (±7 days)] and for 30 days [Day 120 (±7 days)] ]

Evaluate the incidence of alternative antifungal therapy compared to Rezafungin for Injection and the SAR.
28 . Compare the health economics outcome research (HEOR) variable of "Antibiotic Therapy"
[ Time Frame: Once weekly for outpatient, or twice weekly for inpatient, at completion of study drug therapy [Day 90 (±7 days)] and for 30 days [Day 120 (±7 days)] ]

Evaluate the incidence of antibiotic therapy compared to Rezafungin for Injection and the SAR.
Other Outcome Measures:
1. Comparison of Fungal-Free
[ Time Frame: Day 14 (±1 day), Day 28 (±1 day), Day 60 (±5 days), and Day 120 (±7 days) ]

The number of subjects in each treatment group who are fungal-free.
2. Comparison of Fungal-Free
[ Time Frame: Day 14 (±1 day), Day 28 (±1 day), Day 60 (±5 days), and Day 120 (±7 days) ]

The percentage of subjects in each treatment group who are fungal-free.
3. Comparison of Presence and Severity of GHVD
[ Time Frame: Day 90 (±7 days) ]

Evaluate the presence and severity of GVHD in subjects randomized to Rezafungin for Injection compared to the SAR.
4. Comparison of Fungal-Free with AML
[ Time Frame: Day 90 (±7 days) ]

The number of subjects in each treatment group who are fungal-free with an underlying diagnosis of acute myeloid leukemia (AML).
5. Comparison of Fungal-Free with AML
[ Time Frame: Day 90 (±7 days) ]

The percentage of subjects in each treatment group who are fungal-free with an underlying diagnosis of acute myeloid leukemia (AML).
6. Compare Incidence of IFD
[ Time Frame: Day 14 (±1 day), Day 28 (±1 day), Day 60 (±5 days), Day 90 (±7 days), and Day 120 (±7 days) ]

Evaluate the incidence of proven, probable, possible, and presumptive IFD in subjects randomized to Rezafungin for Injection compared to the SAR.
7. Compare Relapse-Free Survival
[ Time Frame: Day 1 through follow-up visit (Day 120) ]

Evaluate relapse-free survival, with and without adjustment for patient comorbidity indices, in subjects randomized to Rezafungin for Injection compared to the SAR.
8. Evaluate PK (Cmax)
[ Time Frame: Day 0 (±2 days) within 10 minutes before end of infusion, and one sample between end of infusion and 12 hours after end of infusion; Days 1-4, one sample at any time; Day 7 (±1 day), Day 28 (±1 day), and Day 63 (±1 day) prior to dosing; and EOT visit ]

Evaluate maximum plasma concentration (Cmax).
9. Evaluate PK (Tmax)
[ Time Frame: Day 0 (±2 days) within 10 minutes before end of infusion, and one sample between end of infusion and 12 hours after end of infusion; Days 1-4, one sample at any time; Day 7 (±1 day), Day 28 (±1 day), and Day 63 (±1 day) prior to dosing; and EOT visit ]

Evaluate time to Cmax.
10. Evaluate PK (AUC)
[ Time Frame: Day 0 (±2 days) within 10 minutes before end of infusion, and one sample between end of infusion and 12 hours after end of infusion; Days 1-4, one sample at any time; Day 7 (±1 day), Day 28 (±1 day), and Day 63 (±1 day) prior to dosing; and EOT visit ]

Evaluate area under the curve (AUC).
11. Compare Post-Engraftment Cytopenias and Transfusion Requirements
[ Time Frame: Day 1 through follow-up visit (Day 120) ]

Evaluate post-engraftment cytopenias and transfusion requirements of Rezafungin for Injection compared to the SAR.
12. Compare Infections Caused by TMP/SMX-Sensitive Organisms
[ Time Frame: Day 14 (±1 day), Day 28 (±1 day), Day 60 (±5 days), Day 90 (±7 days), and Day 120 (±7 days) ]

Evaluate infections caused by TMP/SMX-sensitive organisms (Toxoplasma gondii [T. gondii], Nocardia spp.) in Rezafungin for Injection compared to the SAR.
13. Compare Antifungal Prophylaxis
[ Time Frame: Day 14 (±1 day), Day 28 (±1 day), Day 60 (±5 days), Day 90 (±7 days), and Day 120 (±7 days) ]

Evaluate interruption and discontinuation of antifungal prophylaxis due to suspected IFDs of Rezafungin for Injection compared to the SAR.
14. Compare the health economics outcome research (HEOR) variable of "Days in Hospital"
[ Time Frame: Once weekly for outpatient, or twice weekly for inpatient, at completion of study drug therapy [Day 90 (±7 days)] and for 30 days [Day 120 (±7 days)] ]

Evaluate the number of hospital days for subjects randomized to Rezafungin for Injection compared to the SAR.
15. Compare the health economics outcome research (HEOR) variable of "Days in Intensive Care Unit (ICU)"
[ Time Frame: Once weekly for outpatient, or twice weekly for inpatient, at completion of study drug therapy [Day 90 (±7 days)] and for 30 days [Day 120 (±7 days)] ]

Evaluate the number of days in ICU for subjects randomized to Rezafungin for Injection compared to the SAR.
16. Compare the health economics outcome research (HEOR) variable of "Readmission due to Infectious Disease Diagnosis"
[ Time Frame: Once weekly for outpatient, or twice weekly for inpatient, at completion of study drug therapy [Day 90 (±7 days)] and for 30 days [Day 120 (±7 days)] ]

Evaluate readmission(s) due to infectious disease diagnosis for subjects randomized to Rezafungin for Injection compared to the SAR.
17. Compare the health economics outcome research (HEOR) variable of "Readmission due to Invasive Fungal Disease Diagnosis"
[ Time Frame: Once weekly for outpatient, or twice weekly for inpatient, at completion of study drug therapy [Day 90 (±7 days)] and for 30 days [Day 120 (±7 days)] ]

Evaluate readmission(s) due to invasive fungal disease diagnosis for subjects randomized to Rezafungin for Injection compared to the SAR.
18. Compare the health economics outcome research (HEOR) variable of "Alternative Antifungal Therapy"
[ Time Frame: Once weekly for outpatient, or twice weekly for inpatient, at completion of study drug therapy [Day 90 (±7 days)] and for 30 days [Day 120 (±7 days)] ]

Evaluate the incidence of alternative antifungal therapy compared to Rezafungin for Injection and the SAR.
19. Compare the health economics outcome research (HEOR) variable of "Antibiotic Therapy"
[ Time Frame: Once weekly for outpatient, or twice weekly for inpatient, at completion of study drug therapy [Day 90 (±7 days)] and for 30 days [Day 120 (±7 days)] ]

Evaluate the incidence of antibiotic therapy compared to Rezafungin for Injection and the SAR.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Willing and able to provide written informed consent.
  2. Males or females ≥18 years of age.
  3. Receiving a human leukocyte antigen (HLA) matched allogeneic peripheral BMT from a family or unrelated donor, HLA-mismatched related or unrelated donor, or haploidentical donor.
  4. Diagnosed with 1 of the following underlying diseases:
    1. Acute myeloid leukemia (AML), with or without a history of myelodysplastic syndrome, in first or second complete remission.
    2. Acute lymphoblastic leukemia, in first or second complete remission.
    3. Acute undifferentiated leukemia in first or second remission.
    4. Acute biphenotypic leukemia in first or second complete remission.
    5. Chronic myelogenous leukemia in either chronic or accelerated phase.
    6. One of the following myelodysplastic syndrome(s) defined by the following:

    i. Refractory anemia.

    ii. Refractory anemia with ringed sideroblasts.

    iii. Refractory cytopenia with multilineage dysplasia.

    iv. Refractory cytopenia with multilineage dysplasia and ringed sideroblasts.

    v. Refractory anemia with excess blasts - 1 (5-10% blasts).

    vi. Refractory anemia with excess blasts - 2 (10-20% blasts).

    vii. Myelodysplastic syndrome, unclassified.

    viii. Myelodysplastic syndrome associated with isolated del (5q).

    g. Lymphoma (including Hodgkin's) with chemosensitive disease (i.e., response to chemotherapy) and receiving a related donor transplant.

    h. Aplastic anemia.

    i. Primary or secondary myelofibrosis.

    ix j. Chronic myelomonocytic leukemia.

    k. Chronic lymphocytic leukemia.

    l. Drepanocytosis (sickle cell anemia).

    m. Red blood cell aplasia.

    n. Myeloproliferative disorder, unclassified.

    o. Multiple myeloma (plasma cell myeloma).

  5. Receiving myeloablative or reduced-intensity conditioning regimens.
  6. Adequate renal and hepatic function, within 6 weeks of initiation of conditioning, as measured by: Adequate renal and hepatic function prior to initiation of conditioning regimen, therefore between 40 days prior and 10 days prior to BMT, documented as follows:
    1. Hepatic (within 72 hours of Day 0): alanine aminotransferase Hepatic: alanine aminotransferase less than or equal to (≤) 2.5 × upper limit of normal (ULN) and total serum bilirubin ≤1.5 × ULN (excluding Gilbert's Syndrome).
    2. Renal (within 72 hours of Day 0): Serum creatinine within normal range for age or if serum creatinine above ULN range for age, a creatinine clearance [CrCl]) ≥60 mL/min. Renal: serum creatinine ≤2 milligrams (mg)/deciliter (dL) and with creatinine clearance (CrCl) greater than or equal to (≥) 30 milliliters (mL)/minute (min) without a history of renal transplant, or undergoing weekly dialysis within 4 weeks of the BMT.
  7. Baseline blood samples drawn for serum Platelia galactomannan enzyme immunoassay (GM EIA) and β-D glucan levels within 14 days before randomization, with results available prior to randomization.
  8. Baseline Toxoplasma serologies available within 6 weeks prior to randomization.
  9. Baseline glucose-6-phosphate dehydrogenase (G6PD) deficiency testing with no evidence of G6PD deficiency performed within 6 weeks any time prior to randomization.
  10. Female subjects of child-bearing potential <2 years post-menopausal (unless surgically sterile) must agree to and comply with using 1 barrier method (e.g., female condom with spermicide) plus one other highly effective method of birth control (e.g., oral contraceptive, implant, injectable, indwelling intrauterine device, vasectomized partner), or sexual abstinence (only possible if it corresponds to the subject's usual lifestyle) while participating in this study, and for 30 days after the last dose of study drug. Male subjects must be vasectomized, abstain from sexual intercourse, or agree to use barrier contraception (condom with spermicide), and also agree not to donate sperm while participating in the study and for 120 days from the last IV dose of study drug.

Exclusion Criteria:

  1. Diagnosis of AML not in morphological remission.
  2. Diagnosis of chemotherapy-resistant lymphoma: a first relapse can occur provided that a second complete remission has occurred.
  3. Suspected or diagnosed invasive fungal disease (IFD) within 4 weeks of screening.
  4. Diagnosed symptomatic heart failure with left ventricular ejection fraction (LVEF) at rest ≤ 40 50%, LVEF >40% but fails to improve with exercise, or shortening fraction ≤26%.
  5. Personal or family history of Long QT interval on ECG electrocardiogram (ECG) (QT) syndrome or a prolonged QT interval corrected for heart rate by Fridericia's formula ( QTc QTcF) interval (>470 msec milliseconds [msec] in males and >480 msec in females); or concurrent administration of terfenadine, cisapride, astemizole, erythromycin, pimozide, or quinidine, or halofantrine.
  6. Diagnosed reduced lung function with either diffusion capacity (corrected for hemoglobin ), ) or forced expiratory volume in 1 second (FEV1 , forced vital capacity ) 45 70% of predicted value, or O2 saturation ≤ 85 82% on room air.
  7. Suspected or documented PCP within 2 years of screening.
  8. Positive baseline serum Platelia GM EIA (≥ 0.5) and/or β-D glucan assay (Fungitell ≥80 picograms [pg]/mL or Fujifilm Wako >11 pg/mL ) ) within 14 days of transplant.
  9. Receipt of previous allogeneic BMT.
  10. Planned receipt of cord blood for transplantation.
  11. Planned peripheral blood or marrow autograft.
  12. Not applicable to protocol Amendment 6.
  13. Underlying diagnosis of multiple myeloma.
  14. Grade 2 or higher ataxia, tremor, motor neuropathy, or sensory neuropathy, per NCI CTCAE National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
  15. History of severe (Grade ≥3) ataxia, neuropathy or tremors; or a diagnosis of multiple sclerosis or a movement disorder (including Parkinson's disease or Huntington's disease).
  16. . .
    1. Planned or ongoing intake at screening of a known severe neurotoxic medication or with a known moderate neurotoxic medication in a patient with ataxia, tremor, motor neuropathy, or sensory neuropathy of CTCAE version 5.0 Grade 1 or higher.
    2. Any contraindication or a medication or supplement known to severely interact with the standard antimicrobial regimen (SAR) as detailed in the US Prescribing Information (USPI) or Summary of Product Characteristics (SmPC) of fluconazole, posaconazole, or TMP/SMX.
  17. Planned or ongoing therapy at screening with a known neurotoxic medication for a complete list of prohibited neurotoxic medications).
  18. Known hypersensitivity to Rezafungin for Injection, any echinocandin, fluconazole, posaconazole, other azole antifungal, or to any of their excipients.
  19. Known hypersensitivity or inability to receive TMP/SMX or any of its excipients, including but not limited to anaphylaxis, exfoliative skin disorders, or acute porphyria.
  20. Recent use of an investigational medicinal product within 28 days of the first dose of prophylactic study drug or greater to assure more than 5 half-lives have passed to prevent overlapping toxicities when this study's investigational product is dosed, or presence of an investigational device at the time of screening.
  21. Known infection with HIV. Subjects with unknown HIV status should be tested for HIV antibodies per standard of care.
  22. Known infection with HIV.
  23. Pregnant or lactating females.
  24. The Principal Investigator (PI) determines that the subject should not participate in the study.
  25. Considered unlikely to follow up for 90 days after receipt of the BMT due to logistic concerns (i.e., location relative to transplant center).
  26. Known liver cirrhosis, diagnosed according to country or Medical Society specific guidelines and documented in the medical records prior to initiating conditioning regimen.
  27. Body weight >130 kilograms (kg) at screening.
Open or close this module Contacts/Locations
Central Contact Person: Head of Clinical Operations
Telephone: 858-888-7868
Email: clinicaltrialinfo@cidara.com
Study Officials: Rolando Viani, MD Taylor Sandison, MD, MPH
Study Director
Cidara Therapeutics Inc.
Locations: United States, Alabama
University of Alabama at Birmingham
[Recruiting]
Birmingham, Alabama, United States, 35233
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
United States, California
UCLA Center for Health Sciences
[Suspended]
Los Angeles, California, United States, 90095
United States, Georgia
Augusta University Medical Center
[Recruiting]
Augusta, Georgia, United States, 30912
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
United States, Illinois
University of Chicago
[Recruiting]
Chicago, Illinois, United States, 60637
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
United States, Maryland
University of Maryland Medical Center
[Recruiting]
Baltimore, Maryland, United States, 21201
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
United States, Minnesota
Mayo Clinic
[Recruiting]
Rochester, Minnesota, United States, 55905
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
United States, New Jersey
Hackensack University Medical Center
[Recruiting]
Hackensack, New Jersey, United States, 07601
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
United States, Oklahoma
The University of Oklahoma College of Medicine
[Recruiting]
Oklahoma City, Oklahoma, United States, 73104
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
United States, Washington
Fred Hutchinson Cancer Center
[Recruiting]
Seattle, Washington, United States, 98108
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
Belgium
University Hospitals Leuven, Campus Gasthuisberg - UZ Leuven
[Recruiting]
Leuven, Belgium, 3000
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
Belgium, West Vlaanderen
AZ Sint-Jan
[Recruiting]
Brugge, West Vlaanderen, Belgium, 8000
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
Canada
Hamilton Health Sciences' Juravinski Hospital
[Recruiting]
Hamilton, Canada, L8V1C3
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
McGill University Health Center
[Recruiting]
Montréal, Canada, H4A3J1
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
France
Jean Minjoz Hospital
[Recruiting]
Besançon, France, 25030
Contact:Contact: Director of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
Henri Mondor Hospital
[Recruiting]
Créteil, France, 94000
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
Grenoble Alpes University Hospital Center
[Recruiting]
Grenoble, France, 38043
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
University Hospital of Limoges
[Recruiting]
Limoges, France, 87042
Contact:Contact: Director of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
University Hospital of Nantes
[Recruiting]
Nantes, France, 44093
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
Hospital Saint Antoine Ap-Hp
[Recruiting]
Paris, France, 75012
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
University Hospital of Bordeaux
[Recruiting]
Pessac, France, 33604
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
Lyon-Sud Hospital Center
[Recruiting]
Pierre-Bénite, France, 69495
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
Germany
University Hospital Carl Gustav Carus Dresden
[Terminated]
Dresden, Germany, 01307
Essen University Hospital
[Withdrawn]
Essen, Germany, 45147
University Hospital of Cologne
[Recruiting]
Köln, Germany, 50937
Contact:Contact: Director of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
Johannes Gutenberg University Medical Center
[Terminated]
Mainz, Germany, 55131
University Hospital Münster
[Recruiting]
Münster, Germany, 48149
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
Italy
San Martino Polyclinic Hospital
[Recruiting]
Genova, Italy, 16132
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
Agostino Gemelli University Policlinic
[Recruiting]
Rome, Italy, 00168
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
Humanitas Cancer Center
[Recruiting]
Rozzano, Italy, 20089
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
Spain
University Hospital Vall d'Hebron
[Recruiting]
Barcelona, Spain, 08035
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
Hospital Clinic of Barcelona
[Terminated]
Barcelona, Spain, 08036
Hospital de la Princesa
[Withdrawn]
Madrid, Spain, 28006
University Hospital Ramon y Cajal
[Recruiting]
Madrid, Spain, 28034
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
Puerta de Hierro Majadahonda University Hospital
[Recruiting]
Majadahonda, Spain, 28220
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
University Hospital of Salamanca
[Recruiting]
Salamanca, Spain, 37007
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
University Hospital of Valencia
[Recruiting]
Valencia, Spain, 46010
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
La Fe University and Polytechnic Hospital
[Recruiting]
Valencia, Spain, 46026
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
Switzerland
University Hospitals Geneva
[Recruiting]
Geneva, Switzerland, 1211
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
Turkey
Hacettepe University School of Medicine
[Recruiting]
Ankara, Turkey, 06230
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
Ankara University School of Medicine
[Recruiting]
Ankara, Turkey, 06620
Contact:Contact: Head of Clinical Operations 858-888-7868 clinicaltrialinfo@cidara.com
United Kingdom
Kings College Hospital NHS Foundation Trust
[Suspended]
London, United Kingdom, SE5 9RS
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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