Our Trials

Haematology Clinical Trial Unit - Current  Open to recruitment trials as at August 2019

For more information please contact:
Lisa Demosthenous
Haematology Clinical Trial Unit Manager
lisa.demosthenous@svha.org.au
Ph: (03) 9231 3182 NBCR registries

A/Prof  Hang Quach MBBS (Hons) SpecCertOC FRACP FRCPA MD
Director of Haematology
hang.quach@svha.org.au

Multiple Myeloma

Newly Diagnosed

MM19 (NDMM)

A Phase 3 trial of thalidomide-dexamethasone consolidation versus thalidomide-dexamethasone-Ixazomib consolidation for transplant eligible multiple myeloma patients undergoing a single ASCT as part of front-line therapy

Open to recruitment

PERSEUS EMN17/54767414MMY3014 (NDMM)

 Phase 3 Study Comparing Daratumumab, Velcade, Lenalidomide, and Dexamethasone (DVRd) vs Velcade, Lenalidomide, and Dexamethasone (VRd) in Subjects with Previously Untreated Multiple Myeloma who are Eligible for High Dose Therapy - The Perseus Trial

Open to recruitment

IrIL (ND MM)

A prospective Phase II study of Isatuximab Rescue for Inadequate response to Lenalidomide and Dexamethasone in transplant ineligible patients with newly diagnosed multiple myeloma

Open to recruitment

MM21 (ND MM)

A multicentre, single arm, study of daratumumab-lenalidomide-dexamethasone (DRd) for newly diagnosed transplant eligible multiple myeloma patients who fail bortezomib-based induction therapy.

Open to recruitment

Relapsed Refractory

AbbVie M15-654 (R/R MM)

A Phase 1/2, Multicenter, Dose-Escalation and Expansion Study of Combination Therapy with Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Subjects with Relapsed or Refractory Multiple Myeloma

On Hold

Amgen AMG424 20160445 (R/R MM)

A Phase 1, First-in-Human, Open-Label Study Evaluating the Safety,Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 424 in Subjects with Multiple Myeloma

On Hold

GSK207497 DREAMM 6 (R/R MM)

A Phase I/II, Open-label, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-Drug Conjugate GSK2857916 Administered in Combination with Lenalidomide Plus Dexamethasone (Treatment A), or Bortezomib Plus Dexamethasone (Treatment B) in Participants with Relapsed / Refractory Multiple Myeloma

Open to recruitment

CLL & Lymphomas

Treatment Naïve

BGB3111_304 (TN CLL)

An International, Phase 3, Open-label, Randomized Study of BGB-3111 Compared with Bendamustine plus Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Open to recruitment

ALLG HD10 (TN HL)

Treatment optimization trial in the first-line treatment of advanced stage Hodgkin lymphoma; comparison of 6 cycles of escalated BEACOPP with 6 cycles of BrECADD advanced stage Hodgkin lymphoma; comparison of 4-6 cycles of escalated BEACOPP with 4-6 cycles of BrECADD

Open to Recruitment

AUSTIN 1st FLOR (TN FL)

First-line treatment for grade 1-3A Follicular Lymphoma using Opdivo (nivolumab) plus Rituximab: The 1st FLOR study

Open to Recruitment

APML5 (TN APML)

A phase I pharmacokinetic evaluation of oral arsenic trioxide in previously untreated patients with acute promyelocytic leukaemia (ALLG APML5 study)

Open to recruitment

Relapsed Refractory

Ascentage APG-2575-001 (R/R CLL, WM, DLBCL, AML, NHL, MCL)

 A Phase I Study of the Safety, Tolerability, Pharmacokinetic AND Pharmacodynamic Properties of Orally AdministERed APG-2575 in Patients with hematologic malignancies

Open to recruitment

BGB-3111-305 (R/R CLL)

A Phase 3, Randomized Study of Zanubrutinib (BGB-3111) Compared with Ibrutinib in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Open to recruitment

Amgen 20140286 - Subcut Blinatumomab (R/R NHL)

A Phase 1b Open-label Study Investigating the Safety and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin’s Lymphoma

Open to recruitment

Genentech GO29781 (R/R DLBCL, FL, MZL, NHL, RT, SLL, MCL)

An Open-Label, Multicenter, Phase I Trial Evaluating the Safety and Pharmacokinetics of Escalating Dose of BTCT4465A in Patients with Relapsed or Refractory B-Cell Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia

Open to recruitment

TG-1701-110 (R/R CLL, WM, NHL )

A Phase 1 Pharmacokinetic and Pharmacodynamics Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients with B-Cell Malignancies

Open to recruitment

MERCK (MK-4280-003) (R/R HL, DLBCL, NHL)

A Phase 1b Clinical Study to Evaluate the Safety and Efficacy of a Combination of MK-4280 and Pembrolizumab (MK-3475) in Participants with Hematologic Malignancies

Open to recruitment

Registries

Myeloma 1000 Registry

The Myeloma 1000 Project

Open to recruitment

MRDR Registry

Myeloma & Related Diseases Registry

Open to recruitment

NBCR

Australasian Leukemia and Lymphoma Group National Blood Cancer Registry (previously known as AMLM18)

Open to recruitment

Bleeding Disorders

TREATT

TREATT Trial to Evaluate Tranexamic acid therapy in Thrombocytopenia. A double blind randomized controlled trial evaluating the safety and efficacy of Tranexamic acid in patients with hematological malignancies with severe thrombocytopenia.

Open to recruitment

 

Neurosciences

For more information please contact:
Emma Priest
Clinical Research Nurse
emma.priest@svha.org.au

Ph: (03) 9231 3551

Glioma Associated Seizures

Pegasus: Perampanel in glioma associated seizures – efficacy and safety: a pilot phase II randomised controlled trial

Open to recruitment

Oncology

For more information please contact:
oncologytrialcoordinators@svha.org.au

 

Breast Cancer

ANZ 1601/BIG 16-02

A randomised phase III trial of adjuvant radiation therapy versus observation following breast conserving surgery and endocrine therapy in patients with molecularly characterised luminal A early breast cancer

Recruitment paused

 TRIO033

(New Adjuvant Trial with LEE) Phase III clinical trial of ribociclib (LEE011) with endocrine therapy in the adjuvant treatment of HR +ve, HER2-ve early breast cancer

Recruitment paused

 RAD1901-308

Elacestrant Monotherapy Vs. Standard Of Care For The Treatment Of Patients With Er+/Her2- Advanced Breast Cancer Following Cdk4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-Label, Active-Controlled, Multicenter Trial

Recruitment paused

 Glioblastoma

 A phase III trial of extended temozolomide in newly diagnosed glioblastoma (EX-TEM) Recruitment paused

 Upper GI

 SOM vs DXA

A prospective pilot study of body composition assessment in gastric and oesophageal cancers at St Vincent’s Hospital

Recruitment paused

 AG0407GR

A randomised phase II/III trial of preoperative chemoradiotherapy versus preoperative chemotherapy for resectable gastric cancer

Recruitment paused

 Lower GI (Colon)

 ctDNA-08

Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Stage III Colon Cancer: A Multicentre Phase II/III Randomised Controlled Study

Recruitment paused

 Lower GI (Colorectal)

Shared chare of colorectal cancer survivors  Recruitment paused 

 Lower GI (Rectal)

 ctDNA-11

Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Locally Advanced Rectal Cancer: A Multicentre Randomised Study

Recruitment paused 

 Non-Small Cell Lung Cancer (NSCLC)

 CTC 0209 / ALTG 16/009

A Phase 2 trial of durvalumab (MEDI4736) and tremelimumab with chemotherapy in metastatic EGFR mutant non-squamous non-small cell lung cancer (NSCLC) following progression on EGFR Tyrosine Kinase Inhibitors (TKIs) (ILLUMINATE)

Recruitment paused

 MS200647_0005

A phase II multicentre randomized, open label controlled study of M7824 in combination with chemoradiation followed by consolidation with M7824 in comparison with chemoradiation followed by consolidation with Durvalumab or M7824 in participants with unresectable Stage III NSCLC

Recruitment paused 

 Pancreatic

 ctDNA-09

Circualting tumour DNA analysis informing adjuvant chemotherapy in early stage Pancreatic cancer: A multi-centre randomised study (Dynamic-Pancreas)

Recruitment paused

 2016.2

Pancreatic cancer: Understanding Routine Practice and Lifting End results (PURPLE) A Prospective Pancreatic Cancer clinical registry

Recruitment paused 

8951-CL-5201

A Phase 2, Open-Label, Randomized Study to Assess the Antitumor Activity and Safety of Zolbetuximab (IMAB362) in Combination with Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects with Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma

Recruitment paused

 Prostate

I3Y-MC-JPCM

A Phase 2, Randomised, Double-blind, Placebo-Controlled Study of Abiraterone Acetate Plus Pednisone with or without Abemaciclib in Patients with Metastatic Castration Resistant Prostate Cancer

Recruitment paused

 Esophageal

 BGB-A317-306

A Randomized, Placebo-controlled, double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in combination with chemotherapy as First-Line Treatment in Patients with Unresectable, Locally advanced recurrent or metastatic Esophageal Squamous Cell Carcinoma

Recruitment paused

 Cutaneous Squamous Cell Carcinoma (CSCC)

 R2810-ONC-1788

A Randomised placebo-controlled double blind study of adjuvant cemiplimab versus placebo after surgery and radiation therapy in patients with high risk cutaneous squamous cell carcinoma

Recruitment paused

 Liver

 CA209-9DW

Bristol-Myers Squibb, A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination with Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants with Advanced Hepatocellular Carcinoma

Recruitment paused

 Solid Tumors

 42756493CAN2002

A Phase 2 Study of Erdafitinib in Subjects with Advanced Solid Tumors and FGFR Gene Alterations

Recruitment paused

 Multiple

 DB-020-002

Phase 1 Randomised, double-blind, placebo controlled, multicenter study to evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics or Repeated doses of DB-020 in patients receiving Cisplatin

Recruitment paused