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 Perth Blood Institute - 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

 

Perth Blood Institute - 9200 4904

Links

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

 

Perth Blood Institute - 9200 4904

Links

US National Library of Medicine

 

Cold Agglutinin Disease

CADENZA Study

Registered Title

A Phase 3, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of BIVV009 in patients with primary cold agglutinin disease without a recent history of blood transfusion.

Purpose

The purpose of Part A is to determine whether sutimlimab administration results in a greater than or equal to (>=)1.5 gram per deciliter (g/dL) increase in hemoglobin (Hgb) level and avoidance of transfusion in participants with primary cold agglutinin disease (CAD) without a recent history of blood transfusion. The purpose of Part B is to evaluate the long-term safety and tolerability of sutimlimab in participants with primary CAD.

Lay Summary

N/A

WA Trial Sites

Perth Blood Institute - 6200 4904

Links

US National Library of Medicine

 

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Non-Hodgkin Lymphoma (NHL)

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

 

Perth Blood Institute - 9200 4904

Links

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

 

Perth Blood Institute - 9200 4904

Links

US National Library of Medicine

 

CHRONOS-3 Study

Registered Title

A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Copanlisib in Combination with Rituximab in Patients with Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL).

Purpose

The purpose of this study is to evaluate whether copanlisib in combination with rituximab is superior to placebo in combination with rituximab in prolonging progression free survival (PFS) in patients with relapsed iNHL who have received one or more lines of treatment, including rituximab and who either had a treatment-free interval of ≥ 12 months after completion of the last rituximab-containing treatment, or who are unwilling to receive chemotherapy/for whom chemotherapy is contraindicated on reason of age, comorbidities, and/or residual toxicity.

Lay Summary

 

WA Trial Sites

 

Perth Blood Institute -9200 4904

Links

US National Library of Medicine

 

ACERTA ACE-LY-308 Study

Registered Title

A Study of Bendamustine and Rituximab Alone Versus in Combination with Acalabrutinib in Subjects with Previously Untreated Mantle Cell Lymphoma

Purpose

This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle cell lymphoma.

Lay Summary

N/A

WA Trial Sites

Perth Blood Institute Logo

Perth Blood Institute
info@pbi.org.au
Ph. (08) 9200 4904

Links

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

 

Perth Blood Instutute - 9200 4904

Links

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

Perth Blood Institute - 9200 4904

Links

Australian & New Zealand Clinical Trials Registry