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.

 

Acute Myeloid Leukaemia

AG-221-AML-005

Registered Title

A Phase 1b/2 Open-Label, Randomized Study of 2 Combinations of Isocitrate Dehydrogenase (Idh) Mutant Targeted Therapies Plus Azacitidine: Oral Ag-120 Plus Subcutaneous Azacitidine and Oral Ag-221 Plus Sc Azacitidine in Subjects with Newly Diagnosed Acute Myeloid Leukemia Harboring an Idh1 or an Idh2 Mutation, Respectively, Who are Not Candidates to Receive Intensive Induction Chemotherapy.

Purpose

This Phase 1b/2 study is an open-label, randomized, multicentre trial to evaluate the safety and efficacy of oral AG-120 + SC azacitidine and oral AG-221 + SC azacitidine in subjects with newly diagnosed AML harbouring an IDH1 or an IDH2 mutation, respectively. The study population consists of subjects who are not candidates to receive intensive Inductive Chemotherapy (IC).

The study comprises a Phase 1b dose-escalation stage and a Phase 2 randomized stage. The Phase 1b stage is an open-label dose-finding study to evaluate the safety and tolerability of the combinations of oral AG-120 and oral AG-221 with SC azacitidine to define the RP2Ds of these 2 agents when administered in combination with SC azacitidine.

The Phase 2 stage is an open-label randomized study to evaluate the efficacy of the combinations of oral AG-120 and oral AG-221 with SC azacitidine versus SC azacitidine alone in order to assess the overall response rate (ORR), event-free survival (EFS), and morphologic complete remission (CR).

The Primary Objective for both phases of the study is to assess the efficacy of the combination treatments of oral AG-120 plus SC azacitidine and oral AG-221 + SC azacitidine versus SC azacitidine in subjects with newly diagnosed AML harbouring an IDH1 or an IDH2 mutation, respectively, who are not candidates to receive intensive IC.

Lay Summary

N/A

WA Trial Sites

Royal Perth Hospital logo

RPH Haematology
Ph. (08) 9224 2405

Links

US National Library of Medicine

 

AML M16

Registered Title

Sorafenib in combination with intensive chemotherapy for previously untreated adult FLT3-ITD positive AML: a phase 2 randomised double-blind placebo controlled multi-centre study.

Purpose

The purpose of this study is to compare the effects, good and/or bad, of a standard chemotherapy regimen for FLT3 positive AML, combined with or without Sorafenib, to find out which is better.

Lay Summary

This study will look at patients with a specific type of Acute Myeloid Leukaemia (AML) called FLT3 positive AML.

This research is being done because we do not know whether the addition of Sorafenib to chemotherapy treatment is better than chemotherapy treatment alone for FLT3 positive AML. Sorafenib has been tested in over 8,400 patients and is being studied in a number of illnesses, including Acute Myeloid Leukaemia (AML) and in Kidney, Skin, Lung and Liver Cancer. Sorafenib blocks a cell surface receptor called FLT3, which has an important role in the survival and growth of AML cells. Not all leukaemia cells will have the abnormal FLT3 gene. This study will focus only on patients with leukaemia cells detected to have an abnormal FLT3 gene (‘FLT3-positive AML’).

Sorafenib is an investigational drug, which means it has not been approved for use in AML by government health authorities, such as the Australian Therapeutic Goods Administration (TGA) or any other agency, but is permitted to be tested in research studies such as this one. Sorafenib is only approved for use in Australia for certain types of Liver Cancer and Kidney Cancer.

WA Trial Sites

Sir Charles Gairdner Hospital logo

Haematology Care Centre
Sir Charles Gairdner Hospital
Ph. (08) 6383 3207
Fax (08) 9346 4432
Email: louise.hay@health.wa.gov.au

Links

Australian New Zealand Clinical Trials Registry

Acknowledgements: Australian New Zealand Clinical Trials Registry

 

CASCADE Study

Registered Title

A randomized, double-blind phase 3 study of vadastuximab talirine (SGN-CD33A) versus placebo in combination with azacitidine or decitabine in the treatment of older patients with newly diagnosed acute myeloid leukemia (AML).

Purpose

The primary aims of this study is to compare the overall survival of participants who receive vadastuximab talirine (SGN-CD33A) versus placebo in combination with a Hypomethylating agent (either azacitidine or decitabine) in the treatment of older patients with newly diagnosed Acute Myeloid Leukaemia.

The study also aims to evaluate safety profiles and overall survival in the two treatment arms as well as to compare the; - composite complete remission rates between the two treatment arms - event-free survival rates between the two treatment arms - leukaemia free survival rates between the two treatment arms - time to response rates between the two treatment arms.

Lay Summary

N/A

WA Trial Sites

Royal Perth Hospital logo

RPH Haematology
Ph. (08) 9224 2405

Links

US National Library of Medicine

 

Dacitabine Study

Registered Title

A Randomized Phase 2 Study of DACOGEN (Decitabine) Plus JNJ-56022473 (Anti-CD123) Versus DACOGEN (Decitabine) Alone in Patients With AML Who Are Not Candidates for Intensive Chemotherapy.

Purpose

This is a 2-part, open-label, multicentre, Phase 2 study conducted in participants with AML who are suitable for experimental therapy (Part A) and in participants with untreated AML who are not eligible for intense induction chemotherapy or hematopoeitic stem cell transplantation (HSCT) (Part B).

The primary objective of study Part A is to assess the safety of talacotuzumab (formerly CSL362) monotherapy and confirm the recommended Phase 2 dose (RP2D) in participants with acute myeloid leukemia (AML) for whom experimental therapy is appropriate.

The primary objective of study Part B are to assess complete response (CR) rate and overall survival (OS) in participants with AML who are not eligible for intense induction chemotherapy and who are randomly assigned to receive decitabine plus talacotuzumab at the RP2D or decitabine alone.

Lay Summary

N/A

WA Trial Sites

Royal Perth Hospital logo

RPH Haematology
Ph. (08) 9224 2405

Links

US National Library of Medicine

 

IMG-7289-CTP-101 AML Study

Registered Title

A Multi-Center, Open Label Study to Assess the Safety, Steady-State Pharmacokinetics and Pharmacodynamics of IMG-7289 with and without ATRA (Tretinoin) in Patients with Advanced Myeloid Malignancies.

Purpose

This is a Phase 1 open label study of the dose and duration of an orally administered LSD1 inhibitor, IMG-7289, in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Some participants may also receive all-trans retinoic acid (ATRA; also known as tretinoin and Vesanoid®) in combination with IMG-7289.

Lay Summary

N/A

WA Trial Sites

Fiona Stanley Hospital Logo

Fiona Stanley Hospital Haematology
Ph. (08) 6152 6540

Links

US National Library of Medicine

 

QuANTUM-First Study

Registered Title

A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib (AC220) Administered in Combination with Induction and Consolidation Chemotherapy, and Administered as Maintenance Therapy in Subjects 18 to 75 Years Old with Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia.

Purpose

The research project is testing a new treatment for acute myeloid leukaemia (AML). The new treatment is called Quizartinib. The purpose of this research study is to test how well the study medication, Quizartinib, works when taken with standard chemotherapy to put AML into remission and then taken alone to prevent relapses of AML. The type of AML being studied in this clinical trial is known as FLT3-ITD positive AML. This type of AML has an alteration (or mutation) in genes, which may indicate a worse prognosis. Quizartinib works by changing the activity of the FLT3-ITD mutation. Some participants in other studies using Quizartinib had either a complete or a partial remission of their AML, whereas some patients had no response.

Lay Summary

N/A

WA Trial Sites

Fiona Stanley Hospital Logo

Fiona Stanley Hospital Haematology
Ph. (08) 6152 6540

Links

US National Library of Medicine

 

WA ALLG National Blood Cancer Registry

Registered Title

Australasian Leukaemia and Lymphoma Group Common Acute Myeloid Leukaemia Registry.

Purpose

The purpose of this registry is to collect information on selected patients with a suspected or known blood cancer in Australia and New Zealand. The ALLG also collects and stores donated tissue samples from patients in a biorepository. Clinicians, researchers and health service providers apply to the ALLG to access the data and tissue samples in order to find better ways to predict, treat or even prevent disease.

Lay Summary

The ALLG AML Registry will facilitate a number of functions associated with AML trials and thereby promote improved outcomes for patients. Some of the advantages to the establishment of the Registry are:

1. The Registry will enhance patient participation in clinical trials by facilitating cross referral of patients to sites that are running other ALLG AML trials.

2. The clear detail of tests to be conducted at baseline will align with ALLG AML clinical trial screening procedures to minimise burden on the patient and to ensure that the correct samples are collected, thus maximising participation in ALLG AML clinical trials.

3. The registry will also facilitate the implementation of central review and central testing of factors critical to the successful treatment of AML, and enhance consistency in clinical trial populations to ensure trial results are meaningful.

4. The collection of samples for the ALLG Tissue Bank, coupled with details and times of treatment and response status, provides a valuable resource not only for researchers wishing to access these samples through the ALLG Tissue Bank, but also allows stored tissue to be analysed for new prognostic markers and molecular subtypes to ensure that results from ongoing and completed clinical trials can be analysed incorporating stratification of these new entities. This ensures clinical trial results remain relevant in the current landscape of AML treatment.

WA Trial Sites

Sir Charles Gairdner Hospital logo

Haematology Care Centre
Sir Charles Gairdner Hospital
Ph. (08) 6383 3207
Fax (08) 9346 4432
Email: louise.hay@health.wa.gov.au

Fiona Stanley Hospital Logo

Fiona Stanley Hospital Haematology
Ph. (08) 6152 6540

Royal Perth Hospital logo

RPH Haematology
Ph. (08) 9224 2405

Links

Australian New Zealand Clinical Trials Registry

Acknowledgements: Australian New Zealand Clinical Trials Registry

 

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Acute Lymphoblastic Leukaemia

ALL6 Study

Registered Title

A phase II trial of an intensive pediatric protocol incorporating post-induction stratification based on minimal residual disease levels for the treatment of adolescents aged 15 years and above, and young adults aged up to 40 years, with newly diagnosed acute lymphoblastic leukaemia (ALL).

Purpose

In this national study which will be carried out in a large number of Australian adult hospitals, a childhood ALL treatment program, which is currently being used in Children's hospitals in a separate national study, will be adapted for use in ALL patients aged 15 to 40 years, in order to find out whether this treatment can given as effectively as it can in young children.

Lay Summary

Patients will be started on a treatment protocol originally devised in Germany for use in children, and now used widely in other countries, including Australia. The first 2 months of treatment will be standard and given to all patients. This will involve being given several different chemotherapy drugs, according to a fixed schedule. Following this, treatment will depend on certain characteristics of the patient's leukaemia at diagnosis, and on the patient's response to the first 2 months of treatment.

In the protocol that will be used in this study, the treatment given after the initial 2 months will be determined, as it is with children, by the risk group calculated for each individual patient. People who fit into Standard and Medium risk groups will be treated according to a particular protocol designed for children in these risk categories, while people who are shown to have high, medium high or very high risk disease will be given more intensive treatment, usually including bone marrow transplantation.

WA Trial Sites

Sir Charles Gairdner Hospital logo

Haematology Care Centre
Sir Charles Gairdner Hospital
Ph. (08) 6383 3207
Fax (08) 9346 4432
Email: louise.hay@health.wa.gov.au

Fiona Stanley Hospital Logo

Fiona Stanley Hospital Haematology
Ph. (08) 6152 6540

Links

Australian New Zealand Clinical Trials Registry

Acknowledgements: Australian New Zealand Clinical Trials Registry

 

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Chronic Lymphocytic Leukaemia

ASCEND Study

Registered Title

A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator’s Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia.

Purpose

This study is designed to evaluate the efficacy of acalabrutinib compared with rituximab in combination with idelalisib or bendamustine in previously treated subjects with chronic lymphocytic leukemia (CLL).

Lay Summary

N/A

WA Trial Sites

Fiona Stanley Hospital Logo

Fiona Stanley Hospital Haematology
Ph. (08) 6152 6540

Perth Blood Institute Logo

Perth Blood Institute
3/95 Monash Avenue, Nedlands, WA
info@pbi.org.au
Ph. (08) 9200 4904

Links

US National Library of Medicine

 

Care After Lymphoma

Registered Title

Care After Lymphoma (CALy) Trial: A randomised controlled trial testing the effect of a pilot nurse-led lymphoma survivorship clinic with lymphoma survivors to decrease the number of unmet informational needs to reduce anxiety, stress and to increase self-empowerment.

Purpose

This project aims to develop and test a nurse-led model of survivorship care for lymphoma survivors.

Lay Summary

Participants will be randomly allocated to one of two groups. Participants in one group will continue to receive usual follow-up care with their haematologist. Participants in the other group will take part in an evidenced-based survivorship clinic that will provide tailored care to patients who have completed active treatment. The intervention will involve three 1 hour face-to-face structured interviews that will occur over a 6 month period. These will involve discussion and delivery of a survivorship care plan, treatment summary and resource pack. Participants in both groups will be asked to complete a number of questionnaires at baseline, 3 months and 6 months in order to evaluate unmet informational and practical needs, depression, anxiety, stress, coping and self-empowerment. The findings from this study will make a significant contribution to the planning and delivery of survivorship care.

WA Trial Sites

Sir Charles Gairdner Hospital Logo

Haematology Care Centre
Sir Charles Gairdner Hospital
Ph. (08) 6383 3207
Fax (08) 9346 4432
Email: louise.hay@health.wa.gov.au

Links

Australian New Zealand Clinical Trials Registry

 

CLL07 CAMMERAY Trial

Registered Title

An Australasian, phase II, multicentre, randomised, study investigating safety and efficacy for dose reduced fludarabine, cyclophosphamide and iv obinutuzumab (G-FC3) versus oral chlorambucil and iv obinutuzumab (G-Clb) in previously untreated, comorbid (CIRS score greater than or equal to 6), elderly (greater than or equal to 65 years old) patients with chronic lymphocytic leukaemia (CLL).

Purpose

The study is evaluating the efficacy and safety for dose reduced fludarabine, cyclophosphamide and intravenous obinutuzumab (G-FC3) versus oral chlorambucil and intravenous obinutuzumab (G-Clb) in previously untreated, comorbid, elderly patients with chronic lymphocytic leukaemia (CLL).

Lay Summary

N/A

WA Trial Sites

Sir Charles Gairdner Hospital Logo

Haematology Care Centre
Sir Charles Gairdner Hospital
Ph. (08) 6383 3207
Fax (08) 9346 4432
Email: louise.hay@health.wa.gov.au

Links

Australian New Zealand Clinical Trials Registry

 

CLL6 RESIDUUM Trial

Registered Title

An Australasian, Phase III, Multicentre, Randomised Trial Comparing Lenalidomide Consolidation Vs No Consolidation in Patients With Chronic Lymphocytic Leukaemia (CLL) and Residual Disease Following Induction Chemotherapy.

Purpose

This study aims to determine if lenalidomide is capable of extending remission duration in patients with CLL who have detectable residual disease following induction chemotherapy.

Lay Summary

Lenalidomide is active against chemotherapy resistant CLL and may be effective in improving response status following chemotherapy.

WA Trial Sites

Sir Charles Gairdner Hospital Logo

Haematology Care Centre
Sir Charles Gairdner Hospital
Ph. (08) 6383 3207
Fax (08) 9346 4432
Email: louise.hay@health.wa.gov.au

Links

Australian New Zealand Clinical Trials Registry

 

VENICE-II Study

Registered Title

Open-Label, Single Arm, Phase 3b, Multi-Center Study Evaluating the Impact of Venetoclax on the Quality of Life of Relapsed/Refractory Subjects With Chronic Lymphocytic Leukemia (CLL) Including Those With the 17p Deletion or TP53 Mutation OR Those Who Have Received Prior Treatment With B-Cell Receptor Inhibitor.

Purpose

The purpose of this open-label, single-arm study is to evaluate the impact of venetoclax on the quality of life of participants with chronic lymphocytic leukemia (CLL; a type of cancer affecting the blood and the bone marrow) including those with the 17p deletion or TP53 mutation (local lab assessed) OR in CLL participants who have received prior B-Cell Receptor Inhibitor (BCRi) therapy.

Lay Summary

A Study Evaluating Venetoclax in Subjects With Chronic Lymphocytic Leukemia Whose Cancer Has Come Back or Who Had No Response to Previous Cancer Treatments Including Subjects Missing Part of Their Chromosome 17, or TP53 Gene Mutation; or Who Received Prior Treatment With a B-Cell Receptor Inhibitor.

WA Trial Sites

Perth Blood Institute Logo

Perth Blood Institute
3/95 Monash Avenue, Nedlands, WA
info@pbi.org.au
Ph. (08) 9200 4904

Links

US National Library of Medicine

 

 

Chronic Myeloid Leukaemia

Care After Lymphoma

Registered Title

Care After Lymphoma (CALy) Trial: A randomised controlled trial testing the effect of a pilot nurse-led lymphoma survivorship clinic with lymphoma survivors to decrease the number of unmet informational needs to reduce anxiety, stress and to increase self-empowerment.

Purpose

This project aims to develop and test a nurse-led model of survivorship care for lymphoma survivors.

Lay Summary

Participants will be randomly allocated to one of two groups. Participants in one group will continue to receive usual follow-up care with their haematologist. Participants in the other group will take part in an evidenced-based survivorship clinic that will provide tailored care to patients who have completed active treatment. The intervention will involve three 1 hour face-to-face structured interviews that will occur over a 6 month period. These will involve discussion and delivery of a survivorship care plan, treatment summary and resource pack. Participants in both groups will be asked to complete a number of questionnaires at baseline, 3 months and 6 months in order to evaluate unmet informational and practical needs, depression, anxiety, stress, coping and self-empowerment. The findings from this study will make a significant contribution to the planning and delivery of survivorship care.

WA Trial Sites

Sir Charles Gairdner Hospital Logo

Haematology Care Centre
Sir Charles Gairdner Hospital
Ph. (08) 6383 3207
Fax (08) 9346 4432
Email: louise.hay@health.wa.gov.au

Links

Australian New Zealand Clinical Trials Registry

 

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Hodgkin's Lymphoma

There are currently no Hodgkin's Lymphoma trials available for listing.

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Non Hodgkin's Lymphoma

ACE-LY-308 Mantle Cell Lymphoma

Registered Title

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Bendamustine and Rituximab (BR) Alone Versus in Combination with Acalabrutinib (ACP-196) 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
3/95 Monash Avenue, Nedlands, WA
info@pbi.org.au
Ph. (08) 9200 4904

Fiona Stanley Hospital Logo

Fiona Stanley Hospital Haematology
Ph. (08) 6152 6540

Sir Charles Gairdner Hospital logo

Haematology Care Centre
Sir Charles Gairdner Hospital
Ph. (08) 6383 3207
Fax (08) 9346 4432
Email: louise.hay@health.wa.gov.au

Links

US National Library of Medicine

 

ALLG NHL29 IRiC - Diffuse Large B Cell Lymphoma

Registered Title

A Phase II Study of Ibrutinib, Rituximab and mini-CHOP therapy in very elderly patients with newly diagnosed Diffuse Large B Cell Lymphoma (DLBCL).

Purpose

This study will evaluate the deliverability and efficacy of Ibrutinib-R-mini-CHOP chemotherapy in elderly patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL). Who is it for? You may be eligible to join this study if you are aged 75 years or above and have been newly diagnosed with DLBCL for which you have received no prior treatment (excluding prednisone). Study details: All participants in this study will be treated with a chemotherapy regime known as Ibrutinib-R-mini-CHOP. This will include treatment with the drugs prednisone (orally), ibrutinib (orally), rituximab intravenously ((IV) - i.e. administered directly into the vein), cyclophosphamide IV, doxorubicin IV, vincristine IV and Pegfilgrastim G-CSF (subcutaneous injection). Treatment duration will be for up to 8 x 28 day cycles as tolerated. All participants will be regularly assessed for a minimum of 2 years in order to evaluate the safety, toxicity and effectiveness of treatment.

Lay Summary

N/A

WA Trial Sites

Sir Charles Gairdner Hospital logo

Haematology Care Centre
Sir Charles Gairdner Hospital
Ph. (08) 6383 3207
Fax (08) 9346 4432
Email: louise.hay@health.wa.gov.au

Fiona Stanley Hospital Logo

Fiona Stanley Hospital Haematology
Ph. (08) 6152 6540

Links

Australian New Zealand Clinical Trials Registry

 

B-MIND MOR208C204 Diffuse Large B Cell Lymphoma Study

Registered Title

A Phase 2/3, Randomised, Multicentre Study of MOR208 With Bendamustine Versus Rituximab With Bendamustine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL) Who Are Not Eligible for High-Dose Chemotherapy (HDC) and Autologous Stem-Cell Transplantation (ASCT).

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

This is a randomised, two-arm, multicentre, open-label phase II/III efficacy and safety study of MOR208 in combination with BEN versus RTX in combination with BEN given to adult patients who have relapsed after or are refractory to at least one but no more than three prior systemic therapies and have failed, or are not candidates for HDC and ASCT, and have thus exhausted their therapeutic options of demonstrated clinical benefit. At least one prior therapy line must have included a CD20-targeted therapy.

WA Trial Sites

Perth Blood Institute Logo

Perth Blood Institute
3/95 Monash Avenue, Nedlands, WA
info@pbi.org.au
Ph. (08) 9200 4904

Links

US National Library of Medicine

 

Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies

Registered Title

This is a Phase I, Open Label, Multiple Dose, Dose Escalation Study and Expansion study to Investigate the Safety and Pharmacokinetics of the BTK Inhibitor BGB-3111 in Subjects with B-Cell Lymphoid Malignancies.

Purpose

To investigate the safety and action of the study drug BGB-3111 in Subjects with B-Cell Lymphoid Malignancies.

Lay Summary

This is a first-in-human study of a new drug called BGB-3111 to see what effects (good and bad) it has on you and your cancer.

The purpose of this study is to (1) determine if this drug is safe for human use, and (2) find the most effective dose of this drug as a treatment for your disease.

A key purpose of this part of the study is to determine whether once or twice daily dosing is better at targeting the cancer.

BGB-3111 is an experimental treatment. This means that it is not an approved treatment for B-Cell Lymphoid Malignancies in Australia.

WA Trial Sites

Sir Charles Gairdner Hospital logo

Haematology Care Centre
Sir Charles Gairdner Hospital
Ph. (08) 6383 3207
Fax (08) 9346 4432
Email: louise.hay@health.wa.gov.au

Links

US National Library of Medicine

 

BGB 3111 in Combination With Obinutuzumab in Subjects With B-Cell Lymphoid Malignancies

Registered Title

A Phase 1b Study to Assess Safety, Tolerability and Antitumor Activity of the Combination of BGB 3111 With Obinutuzumab in Subjects With B-Cell Lymphoid Malignancies.

Purpose

This study is evaluating the safety and preliminary efficacy of BGB-3111 in combination with obinutuzumab in subjects with B-cell lymphoid malignancies.

Lay Summary

N/A

WA Trial Sites

Royal Perth Hospital logo

RPH Haematology
Ph. (08) 9224 2405

Links

US National Library of Medicine

 

BGB-3111 in Combination With BGB-A317 in Subjects With B-cell Malignancies

Registered Title

A Phase 1b, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Assess Safety, Tolerability and Antitumor Activities of the Combination of BGB-3111 with BGB-A317 in Subjects with B-Cell Lymphoid Malignancies.

Purpose

This is a Phase 1b study to evaluate safety, tolerability, and preliminary efficacy of BGB-3111 in combination with BGB-A317 in subjects with B-cell malignancies, including relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), Waldenström’s  Macroglobulinemia (WM), non-germinal center B-cell (non-GCB) diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), hairy cell leukemia (HCL), transformed FL, and Richter’s transformation.

Lay Summary

N/A

WA Trial Sites

Sir Charles Gairdner Hospital logo

Haematology Care Centre
Sir Charles Gairdner Hospital
Ph. (08) 6383 3207
Fax (08) 9346 4432
Email: louise.hay@health.wa.gov.au

Links

US National Library of Medicine

 

BGB-311-204 Long term extension study

Registered Title

An Open-label Long-Term Extension Study of Bruton’s Tyrosine Kinase (BTK) inhibitor BGB-3111 in B Cell malignancies.

Purpose

To evaluate the long-term safety of BGB-3111 in subjects with B cell malignancies who participated in any BGB-3111 clinical trial.

Lay Summary

N/A

WA Trial Sites

Sir Charles Gairdner Hospital logo

Haematology Care Centre
Sir Charles Gairdner Hospital
Ph. (08) 6383 3207
Fax (08) 9346 4432
Email: louise.hay@health.wa.gov.au

Links

N/A

 

CHRONOS-3 Indolent B-cell Non-Hodgkin's Lymphoma

Registered Title

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

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. Purpose of the study is also to evaluate the safety and tolerability of copanlisib.

Lay Summary

N/A

WA Trial Sites

Perth Blood Institute Logo

Perth Blood Institute
3/95 Monash Avenue, Nedlands, WA
info@pbi.org.au
Ph. (08) 9200 4904

Links

US National Library of Medicine

 

CHRONOS-4 Indolent B-cell Non-Hodgkin's Lymphoma

Registered Title

A Phase III, randomized, double-blind, controlled, multicenter study of intravenous PI3K inhibitor copanlisib in combination with standard immunochemotherapy versus standard immunochemotherapy in patients with relapsed indolent non-Hodgkin’s lymphoma (iNHL).

Purpose

The purposes of this study are to evaluate whether copanlisib in combination with standard immunochemotherapy, is superior to standard immunochemotherapy in prolonging progression-free survival, in patients with relapsed indolent non-Hodgkin’s lymphoma, who have received one or more lines of treatment, including rituximab and alkylating agents. The study has two parts: safety run-in / dose finding part and a phase III placebo-controlled part. The study will start with the safety run-in part, where two dose levels of copanlisib will be tested for safety and tolerability. This will determine the dose to be administered in phase III part.Ê In the phase III part patients who meet the eligibility criteria will be randomly assigned to copanlisib or placebo plus R-CHOP or R-Bendamustine depending on their previous medical history.

Lay Summary

N/A

WA Trial Sites

Fiona Stanley Hospital Logo

Fiona Stanley Hospital Haematology
Ph. (08) 6152 6540

Links

US National Library of Medicine

 

Gilead 1580 - Follicular Lymphoma

Registered Title

Dose Optimization Study of Idelalisib in Follicular Lymphoma (FL) and Small Lymphocytic Lymphoma.

Purpose

The study will evaluate the safety, efficacy, and PK of idelalisib in subjects randomized to either 150 mg BID or 100 mg of idelalisib BID. The target population comprises adults with previously treated relapsed FL who have measurable lymphadenopathy and require therapy according to standard response criteria.

Lay Summary

N/A

WA Trial Sites

Royal Perth Hospital logo

RPH Haematology
Ph. (08) 9224 2405

Links

US National Library of Medicine

 

Jasmine CD20 Positive B-Cell Non-Hodgkin Lymphoma Study

Registered Title

A Randomized, Double-Blind Study Evaluating the Efficacy, Safety and Immunogenicity of ABP 798 Compared with Rituximab in Subjects with CD20 Positive B-Cell Non-Hodgkin Lymphoma.

Purpose

This trial is designed to determine what effects the human body has on the investigational medicine, ABP 798, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with CD 20 positive B-cell non Hodgkin lymphoma. This study will assess if the investigational medicine is safe and effective in treating CD 20 positive B-cell non Hodgkin lymphoma.

Lay Summary

N/A

WA Trial Sites

Fiona Stanley Hospital Logo

Fiona Stanley Hospital Haematology
Ph. (08) 6152 6540

Links

US National Library of Medicine

 

Verdi B-Cell Non Hodgkin Lymphoma Study

Registered Title

A Phase 2/3 Multi-center Study to Evaluate the Safety and Efficacy of Blinatumomab in Subjects with Relapsed/Refractory Aggressive B-Cell Non Hodgkin Lymphoma.

Purpose

This is a phase 2/3 open label, multicenter trial testing blinatumomab monotherapy for the treatment of subjects with Relapsed/Refractory (R/R) aggressive B-NHL not achieving CMR after 2 cycles of standard platinum-based chemotherapy regimens administered as S1. This study incorporates multiple interim analyses for futility, efficacy, and unblinded sample-size re-estimation. In the phase 3 part of the study, blinatumomab will be compared to Investigator's Choice chemotherapy.

Lay Summary

N/A

WA Trial Sites

Fiona Stanley Hospital Logo

Fiona Stanley Hospital Haematology
Ph. (08) 6152 6540

Links

US National Library of Medicine

 

 

Multiple Myeloma

BELLINI M14-031 Study

Registered Title

A Phase 3, Multicenter, Randomized, Double Blind Study of Bortezomib and Dexamethasone in Combination With Either Venetoclax or Placebo in Subjects With Relapsed or Refractory Multiple Myeloma Who Are Sensitive or Naive to Proteasome Inhibitors.

Purpose

This is a Phase 3, multicenter, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of venetoclax plus bortezomib and dexamethasone in subjects with relapsed or refractory multiple myeloma who are considered sensitive or naive to proteasome inhibitors and received 1 to 3 prior lines of therapy for multiple myeloma.

Lay Summary

N/A

WA Trial Sites

Perth Blood Institute Logo

Perth Blood Institute
3/95 Monash Avenue, Nedlands, WA
info@pbi.org.au
Ph. (08) 9200 4904

Fiona Stanley Hospital Logo

Fiona Stanley Hospital Haematology
Ph. (08) 6152 6540

Links

US National Library of Medicine

 

INTREPID-1 Study

Registered Title

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of Oprozomib in Combination with Pomalidomide and Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma.

Purpose

A study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma.

Lay Summary

N/A

WA Trial Sites

Fiona Stanley Hospital Logo

Fiona Stanley Hospital Haematology
Ph. (08) 6152 6540

Links

US National Library of Medicine

 

WA Myeloma and Related Diseases Registry

Registered Title

Myeloma and Related Diseases Registry.

Purpose

Long-term patient follow-up and review of clinical (safety and efficacy) and correlative data outside of clinical trials will be highly valuable in informing optimal treatment strategies for myeloma and its related diseases. Clinical registries provide a useful mechanism to collect data on patterns of treatment and variation in outcomes (both survival and quality of life). They enable clinicians to benchmark against national and international standards and allow evaluation of the translation of advances in therapy (such as introduction in new targeted therapies) into long-term outcomes outside the setting of clinical trials.

Lay Summary

N/A

WA Trial Sites

Sir Charles Gairdner Hospital logo

Haematology Care Centre
Sir Charles Gairdner Hospital
Ph. (08) 6383 3207
Fax (08) 9346 4432
Email: louise.hay@health.wa.gov.au

Links

N/A

 

 

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