PC_Asp_006 - Safety and efficacy of PC945 for the treatment of refractory invasive pulmonary aspergillosis
8
OASIS F901318/0041
9
AMADEUS
10
COSI
11
RESPECT
12
iMMagine-3
13
MoTD
14
CABA-201
Treatment stage
Multiple stages
4
Subtype
GvHD
Count1
Treatment stage
Multiple stages
1
Subtype
IFI
Count3
Treatment stage
Multiple stages
3
Subtype
MDS
Count3
Treatment stage
Multiple stages
3
Subtype
Myeloma
Count2
Treatment stage
Relapsed / refractory
1
Treatment stage
Multiple stages
1
Subtype
Autoimmune disorders
Count1
Treatment stage
Multiple stages
1
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Population
Description
ECOG
PI - Evelina
PI - KCH
PI - GSTT
PI - PRUH
PI - QEH
PI - UHL
Trial summary
Key Eligibility Criteria
Summary
Summary
Summary
Summary
Summary
Summary
Summary
Summary
Summary
Summary
Summary
For adults with AML or MDS deemed fit for allo-SCT
Randomised trial: pre-transplant consolidation therapy vyxeos vs standard consolidation therapy
0-2
Potter, V
Treatment options for older adults with Acute Myeloid Leukaemia (AML) and Myelodysplasia (MDS) are limited. Although stem cell transplantation remains one of the most effective treatments it is associated with severe side effects which have until recently prevented its use in older adults. In the last decade the use of reduced intensity transplants has allowed the extension of the potentially curative effect of transplantation to older patients in whom it was
previously precluded. Although a ma
Randomisation 1:
For adults undergoing HSCT
Phase 3 randomised trial: Rezafungin vs standard treatment to prevent IFI
Not specified
Mehra, V
The ReSPECT trial is a global, randomized, double-blind, controlled, pivotal Phase 3 trial of rezafungin versus the standard antimicrobial regimen to prevent invasive fungal disease due to Candida, Aspergillus and Pneumocystis in subjects undergoing allogeneic BMT. Rezafungin, dosed once-weekly, will be compared to a daily regimen containing multiple drugs including fluconazole or posaconazole, and trimethoprim-sulfamethoxazole, also known as Bactrim, for 90 days, at which time fungal-free survi
≥18 years of age
Adult patients with AML or MDS, able to commence study therapy following allo-SCT
Phase 3 randomised study: Azacitidine vs placebo as maintenance after allo-STC
0-2
Potter, V
Treatment options for older adults with Acute Myeloid Leukaemia (AML) and Myelodysplasia (MDS) are limited. Although stem cell transplantation remains one of the most effective treatments it is associated with severe side effects which have until recently prevented its use in older adults. In the last decade the use of reduced intensity transplants has allowed the extension of the potentially curative effect of transplantation to older patients in whom it was previously precluded. Although a maj
Age > = 16 at the time of signing the informed consent form
For adults awaiting a planned allo-SCT
Phase 2 trial: Thymoglobulin vs. Calcineurin inhibitor or cyclophosphamide as GvHD prophylaxis
Not specified
Krishnamurthy, P
Stem cell transplantation from a matched sibling or unrelated donor (allo-SCT) is the only curative therapy for many children and adults with blood cancer. However allo-SCT remains associated with a number of life-threatening side effects, the most serious of which is ‘graftversus-host disease’ (GvHD). This complication occurs when donor immune cells (the ‘graft’) see the patient’s healthy skin, gut or liver (the ‘host’) as foreign and attacks them. Patients currently receive a combination of d
Availability of suitably matched unrelated donor (9/10 or 10/10)
For adults with high risk acute GvHD
Randomised study: lenzilumab vs placebo
0-3
Avenoso, D
Donor stem cell transplantation is used for treating patients with blood cancers. This is also called allogeneic stem cell transplantation. It is a very intense form of treatment which can cause significant complications. Graft versus host disease (GvHD) is one of the most serious side effects and occurs when the donor immune system attacks the normal tissues in the transplant recipient. There are two types of GvHD. Acute GvHD normally happens within 100 days of the transplant and chronic GvHD h
Stage 1 and Stage 2 - Randomised Cohort
For adults with IFI
Phase 2b study: F901318 as IFI treatment in patients lacking alternative options
Not specified
Mehra, V
In this study all eligible patients will receive the investigational medication to evaluate the efficacy, safety, tolerability and pharmacokinetics (how the medication is processed in the body) profile of F901318 in patients with invasive fungal infection (IFI) lacking suitable alternative treatment options. The study has 3 phases; the Screening phase (up to 7 days), the main study phase (up to 90 days) and the extended treatment phase which will be possible to participate after Medical Monitor
Patients with one of these 4 forms of invasive fungal infection* confirmed by culture or other diagnostic (as agreed with the MM):
Adult patients with refractory invasive pulmonary aspergillosis
Randomised study: nebulised PC945 vs placebo, added to systemic antifungal therapy
Not specified
Mehra, V
A double-blind, randomized, placebo-controlled study to assess the safety and efficacy of nebulized PC945 when added to systemic antifungal therapy for the treatment of refractory invasive pulmonary aspergillosis
Subject is ≥ 18 years.
For adults with invasive fungal infections caused by the Aperigillus species
Phase 3 randomised study: AmBisome followed by standard of care
Not specified
Mehra, V
This study will evaluate the safety and efficacy of an investigational medication in treating Invasive Aspergillosis (IA). Aspergillus species are a type of fungus found in organic matter or the environment. Apergillus infections may lead to a number of diseases in humans including direct invasion of tissue. IA is a very progressive and often fatal infection commonly affecting patients who are immunocompromised. From some patients who do not respond to or cannot tolerate current therapies for IA
Male and female patients ages ≥ 18 years and weighing more than 40 kg, who have been fully informed and who have given voluntary written informed consent, or whose legally authorised representative(s) has been fully informed and has given voluntary written informed consent if applicable, and in compliance with local regulations or Patients unable to write and/or read but who fully understand the oral information given by the Investigator (or nominated representative) who have given oral informed
Adult patients with AML or MDS, able to commence study therapy following allo-SCT
Phase 3 randomised study: Azacitidine vs placebo as maintenance after allo-STC
0-2
Potter, V
Treatment options for older adults with Acute Myeloid Leukaemia (AML) and Myelodysplasia (MDS) are limited. Although stem cell transplantation remains one of the most effective treatments it is associated with severe side effects which have until recently prevented its use in older adults. In the last decade the use of reduced intensity transplants has allowed the extension of the potentially curative effect of transplantation to older patients in whom it was previously precluded. Although a maj
Age > = 16 at the time of signing the informed consent form
For adults with AML or MDS deemed fit for allo-SCT
Randomised trial: pre-transplant consolidation therapy vyxeos vs standard consolidation therapy
0-2
Potter, V
Treatment options for older adults with Acute Myeloid Leukaemia (AML) and Myelodysplasia (MDS) are limited. Although stem cell transplantation remains one of the most effective treatments it is associated with severe side effects which have until recently prevented its use in older adults. In the last decade the use of reduced intensity transplants has allowed the extension of the potentially curative effect of transplantation to older patients in whom it was
previously precluded. Although a ma
Randomisation 1:
For adults undergoing HSCT
Phase 3 randomised trial: Rezafungin vs standard treatment to prevent IFI
Not specified
Mehra, V
The ReSPECT trial is a global, randomized, double-blind, controlled, pivotal Phase 3 trial of rezafungin versus the standard antimicrobial regimen to prevent invasive fungal disease due to Candida, Aspergillus and Pneumocystis in subjects undergoing allogeneic BMT. Rezafungin, dosed once-weekly, will be compared to a daily regimen containing multiple drugs including fluconazole or posaconazole, and trimethoprim-sulfamethoxazole, also known as Bactrim, for 90 days, at which time fungal-free survi
≥18 years of age
For adults with relapsed myeloma, following 1-3 prior lines of therapy
Phase 3 randomised open-label study: Anitocabtagene Autoleucel vs standard of care
Not specified
Benjamin, R
This is a Phase 3, randomized, open-label, multicenter study evaluating the safety and efficacy of anitocabtagene autoleucel versus investigator’s choice from 4 SOCT options in participants with RRMM who have received 1 to 3 prior lines of therapy including an IMiD and an anti-CD38 mAb.
For adults awaiting a planned allo-SCT
Phase 2 trial: Thymoglobulin vs. Calcineurin inhibitor or cyclophosphamide as GvHD prophylaxis
Not specified
Krishnamurthy, P
Stem cell transplantation from a matched sibling or unrelated donor (allo-SCT) is the only curative therapy for many children and adults with blood cancer. However allo-SCT remains associated with a number of life-threatening side effects, the most serious of which is ‘graftversus-host disease’ (GvHD). This complication occurs when donor immune cells (the ‘graft’) see the patient’s healthy skin, gut or liver (the ‘host’) as foreign and attacks them. Patients currently receive a combination of d
Availability of suitably matched unrelated donor (9/10 or 10/10)
For adults with Active Idiopathic Inflammatory Myopathy
This is a Phase 1/2, open-label study designed to evaluate the safety and efficacy of CABA- 201 in adults with active IIM and to identify an appropriate dose for future studies. Any subject who receives CABA-201 will be followed for 156 weeks for efficacy and safety as outlined in the Schedule of Activities. The study will include a minimum of 6 subjects with DM, a minimum of 6 subjects with ASyS, and a minimum of 6 subjects with IMNM. Subjects will receive a single dose of CABA-201 and be evalu