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Haematology Trials - includes Leukaemia, Lymphoma, Myeloma

The following list provides a brief description of haematology trials that are recruiting participants in Western Australia. If you would like more information please follow the links provided, contact one of the trial sites or speak with your doctor.

Please note that this list is based on information provided to the Cancer Council by WA hospitals and may not include all clinical trials that are running in WA.

Where ‘N/A' appears - this means the lacking information has not been provided to date to the Cancer Council.

Relapsed or Refractory Multiple Myeloma in Leukaemia

CANOVA Study

Registered Title	A Phase 3, Multicenter, Randomized, Open Label Study Of Venetoclax And Dexamethasone Compared With Pomalidomide And Dexamethasone In Subjects With T(11;14)-Positive Relapsed Or Refractory Multiple Myeloma
Purpose	A study designed to evaluate the safety and efficacy of venetoclax plus dexamethasone (VenDex) compared with pomalidomide plus dexamethasone (PomDex) in participants with t(11;14)-positive Relapsed or Refractory Multiple Myeloma. Subjects randomized to Arm 2 (PomDex) may elect, if eligible, to receive VenDex therapy after documented disease progression per International Myeloma Working Group (IMWG) criteria
Lay Summary	N/A
WA Trial Sites	Ph. 9200 4904
Links	US National Library of Medicine

Acknowledgments US National Library of Medicine

Immune Thrombocytopenic Purpura

PRN1008 Study

Registered Title	An Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of PRN1008, an Oral BTK Inhibitor, in Patients with Relapsed Immune Thrombocytopenic Purpura
Purpose	This is an adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/μL on two counts no sooner than 7 days apart in the 15 days before treatment begins.
Lay Summary	N/A
WA Trial Sites	Ph. 9200 4904
Links	US National Library of Medicine

Acknowledgement - US National Library of Medicine

Acute Myeloid Leukaemia (AML) and Myelodysplastic Syndrome (MDS)

Commands Study

Registered Title	A phase 3, open-label, randomized study to compare the efficacy and safety of Luspatercept (ACE-536) versus Epoetin Alfa for the treatment of anaemia due to APSS-R, very low, low or intermediate risk Myelodysplastic syndromes (MDS) in ESA Naïve subjects who require red blood cell transfusions
Purpose	The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This is an interventional active-controlled, open-label, randomized Phase 3 study to compare the efficacy and safety of luspatercept (ACE-536) versus epoetin alfa for the treatment of anemia due to IPSS-R very low, low or intermediate risk MDS in ESA naïve subjects who require RBC transfusions. The study is divided into the Screening Period, a Treatment Period and a Post-Treatment Follow-up Period
Lay Summary	N/A
WA Trial Sites	Ph. 9200 4904
Links	US National Library of Medicine

Acknowledgement - US National Library of Medicine

M19-708

Registered Title	Randomized, Open-label, 2-Arm, Multicenter, Phase 3 Study of Venetoclax and Azacitidine Versus Best Supportive Care as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (VIALE-M)
Purpose	The main objective of this study is to evaluate safety and efficacy of venetoclax in combination with azacitidine (AZA) and best supportive care (BSC) compared to BSC as maintenance therapy in adult participants with acute myeloid leukemia (AML) in first remission after conventional chemotherapy. This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose of venetoclax in combination with AZA. Part 2 will be the randomization portion to evaluate if venetoclax in combination with AZA as maintenance therapy improves RFS comparing to BSC. Part 2 begins after Part 1 is completed. During this study, participants will receive venetoclax and azacitidine or best supportive care for approximately 2 years with study visits varying from 1-5 per month.
Lay Summary	N/A
WA Trial Sites	Perth Blood Institute - Ph. (08) 9200 5300
links	US National Library of Medicine

Acknowledgement: US National Library of Medicine

Non-Hodgkin Lymphoma (NHL) B-Cell malignancies

MOST Substudy 1

Registered Title	MoST Substudy 1: Single arm, open label, signal seeking, phase Ib/IIa trial of the CDK4/6 inhibitor palbociclib in patients with tumours with amplified D-type cyclins or CDK4 or inactivation of CDKN2A.
Purpose	This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the activity of palbociclib in patients with advanced cancers and tumours with mutations in components of the Rb-pathway.
Lay Summary	N/A
WA Trial Sites	Linear Clinical Research 0437 873 044
Links	Australian & New Zealand Clinical Trials Registry

Acknowledgement: Australian & New Zealand Clinical Trials Registry

GO29781 Study

Registered Title	An Open-Label, Multicenter, Phase I/IB Trial Evaluating the Safety and Pharmacokinetics of Escalating Doses of BTCT4465A as a Single Agent and Combined With Atezolizumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia
Purpose	This is a Phase 1/1b dose-escalation study of BTCT4465A (Mosunetuzumab) administered as a single agent and in combination with atezolizumab in participants with relapsed or refractory B-cell NHL and CLL. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.
Lay Summary	N/A
WA Trial Sites	Ph. 9200 4904
Links	US National Library of Medicine

Acknowledgement - US National Library of Medicine

B-MIND Study

Registered Title	A Trial to Evaluate the Efficacy and Safety of MOR208 With Bendamustine Versus Rituximab with Bendamustine in Adult Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL).
Purpose	The purpose of the study is to compare the safety and efficacy of MOR208 with BEN versus RTX with BEN in adult patients with relapsed of refractory DLBCL.
Lay Summary	N/A
WA Trial Sites	Ph. 9200 4904
Links	US National Library of Medicine

Acknowledgement - US National Library of Medicine

BGB-A317-3111-10188-101

Registered Title	A Phase 1/2, Dose Escalation and Expansion Study of BGB-10188, a Phosphatidylinositol 3-Kinase Delta (PI3Kδ) Inhibitor, Combined With Zanubrutinib in Patients With Mature B-Cell Malignancies and Combined With Tislelizumab in Patients With Solid Tumors
Purpose	The purpose of this study is to determine the maximum tolerated dose (MTD), recommended Phase 2 dose(RP2D),safety & tolerability of BGB-10188: as monotherapy in participants with mature B-cell malignancies; in combination with zanubrutinib in participants with relapse/refractory follicular lymphoma (R/R FL), mantle cell lymphoma (MCL) or diffuse large B-cell lymphoma (DLBCL); and in combination with tislelizumab in participants with advanced solid tumors.
Lay Summary	N/A
WA Trial Sites	Ph. (08) 9200 4904
Links	US National Library of Medicine

Acknowledgement - US National Library of Medicine

TIDAL Study

Registered Title	Multicenter, Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Phase 2 Study of ME-401 in Subjects with Follicular Lymphoma After Failure of Two or More Prior Systemic Therapies
Purpose	This is the study of the PI3Kδ inhibitor ME-401 in subjects with relapsed/refractory follicular lymphoma after failure of at least 2 prior lines of systemic therapy
Lay Summary	N/A
WA Trial Sites	Ph. 9200 4904
Links	US National Library of Medicine

Acknowledgement - US National Library of Medicine

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Microangiopathic Thrombocytopenia (MAT), including TTP and aHUS

APMAT1 Study

Registered Title	A Multi-centre, Observational Study of Patients with Microangiopathic Thrombocytopenia by the Asian-Pacific Microangiopathic Thrombocytopenia (APMAT) Network.
Purpose	This is an observational study of previously diagnosed and treated microangiopathic thrombocytopenia (MAT) patients. MAT is a rare collection of disorders caused by the formation of intravascular aggregates of platelets resulting in microcirculatory thrombosis, red blood cell destruction and vital end-organ damage. The study will collect clinical and laboratory data to assess the disease characteristics, laboratory features, treatment strategies employed, and clinical outcome
Lay Summary	N/A
WA Trial Sites	Ph. 9200 4904
Links	Australian & New Zealand Clinical Trials Registry

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