Haematology Trials - includes Leukemia, 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                                            Non-Hodgkin's Lymphoma

Bone Marrow Transplant                                              Multiple Myeloma

Chronic Lymphocytic Leukaemia                               Myelodysplasic Syndrome (MDS)

Chronic Myeloid Leukaemia                                        Other Haematology Trials

Hodgkin's Lymphoma

 

Acute Myeloid Leukaemia

 

 CLAVELA

Registered Title

A Randomised Phase III Study of Elacytarabine vs. Investigator's Choice in Patients with Late Stage Acute Myeloid Leukaemia.

Purpose

The aim of this study is to find out if the study drug, elacytarabine, is more effective that standard therapy in the treatment of advanced AML.

Lay Summary

There is currently no standard therapy for late stage AML and patients are often exposed to a range of treatments. Efficacy will be measured by remission rate and overall survival in each group. Safety and tolerability will be assessed by routine blood tests, examinations and observation of adverse events in each group.

 

The study is an open label, randomised phase III study designed to compare the efficacy, safety, and tolerability of elacytarabine single agent with investigator's choice in patients with late stage acute myeloid leukaemia (AML). The patients have been treated with two or three prior regimens for remission induction or re-induction and have either failed or relapsed. The patients will be randomised to receive either elacytarabine or investigator's choice. The investigator must specify their proposed control treatment approach (investigator's choice) for each patient prior to randomisation. Dose adjustments will occur according to guidelines listed in the protocol. Patients will receive 1-2 treatment courses for remission induction, and if remission is attained, 1-2 courses for consolidation. Patients who benefit from the treatment may receive repeated courses of study drug, i.e. elacytarabine or control treatment, even if remission is not attained.

WA Trial Sites

Sir Charles Gairdner Hospital logo

Haematology Care Centre
Sir Charles Gairdner Hospital
Ph. (08) 9346 7615
Fax (08) 9346 4432
Email: nat.eiffler@health.wa.gov.au

Links

US National Library of Medicine

 

Acknowledgements: US National Library of Medicine

 

MDS4 Study 

Registered Title

A Randomised Phase II study comparing the efficacy of 5azacitidine alone versus combination therapy with lenalidomide and 5azacitidine in patients with higher risk myelodysplastic syndromes (MDS) and low marrow blast count acute myeloid leukaemia (AML).

Purpose

The aim of this research is to test the effectiveness of a combination of two new drugs (lenalidomide and 5azacitidine) in patients with MDS and AML. It will test whether the two drugs together are more effective than 5azacitidine by itself, and also whether it is safe to use the two drugs together without too many side effects.

Lay Summary

Currently the standard care for Myelodysplasia (MDS) in Australia is "Best Supportive Care" which is treatments such as blood transfusions and antibiotics to improve people's quality of life rather than treating the underlying disease. Treatment of Acute Myeloid Leukaemia (AML) may include Best Supportive Care, but some people with AML also have treatment with intense chemotherapy. Previous research internationally has shown that 5azacitidine in MDS and some types of AML can improve people's blood cell counts, improve their quality of life and prolong survival in some people.  Also, some trials with lenalidomide have shown positive responses in people with MDS and AML, reducing the need for blood transfusions. It is possible that combining these two drugs will give better results in people with MDS and AML.

WA Trial Sites

Sir Charles Gairdner Hospital logo

Haematology Care Centre
Sir Charles Gairdner Hospital
Ph. (08) 9346 7615
Fax (08) 9346 4432
Email: nat.eiffler@health.wa.gov.au

 

Fremantle Hospital Logo

Fremanlte Hospital

Ph. (08) 9431 2729

Links

Australian New Zealand Clinical Trials Registry

 

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Bone Marrow Transplant

 

ALLG BM07

Registered Title

A Treatment Algorithm Evaluating the Effect of Zoledronic Acid on Bone Mineral Density Loss after Allogeneic Stem Cell Transplantation.

Purpose

Zometa as a prophylactic treatment for bone mineral density loss in cancer patients following allogeneic stem cell transplantation.

Lay Summary

A side-effect of allogeneic stem cell transplantation is a big loss in bone strength. Bone-strength is also called "bone mineral density" (BMD). One of the problems with a loss in bone strength is a higher risk of osteoporosis and bone fractures later in life. Hence, we are keen to look at ways by which this loss in bone-strength can be minimised.

A group of drugs, called bisphosphonates, have been shown to reduce the rate of bone-strength loss after transplants. The current study is a follow-on study that will use a newer and more powerful bisphosphonate drug called zoledronic acid or Zometa®. Zometa® will be given to all patients before transplant but after transplant it will only be given to those patients whose bone mineral density (BMD) scan shows a >3% loss of bone density or to patients who receive large doses of prednisolone (steroid therapy). The aim is to use Zometa® only when it is needed.

The main measure of the success of the study is whether we can stop bone density loss, which will be calculated by comparing the results of the pre-transplant scan with those from the scans at day 100 and 12 months after the transplant.

WA Trial Sites

Royal Perth Hospital logo

RPH Haematology
Ph. (08) 9224 7038

Links

Australian New Zealand Clinical Trials Registry

 

 Acknowledgements: Australian New Zealand Clinical Trials Registry

 

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Chronic Lymphocytic Leukaemia

 

CLL002 Trial 

Registered Title

Phase III, multicentre, randomised, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of Lenalidomide as maintenance therapy for patients with B-Cell chronic Lymphocytic Leukaemia following second -line therapy.

Purpose

The purpose of this study is to determine if Lenalidomide is safe and effective as a maintenance therapy at improving further the quality and duration of response of previous therapy.

Lay Summary

Lenalidomide is currently approved in Australia in combination with dexamethasone, for the treatment of patients with various stages of multiple myeloma.  Lenalidomide is also being studied in other cancers. 

This study will compare the effects (good and bad) of lenalidomide with a placebo (non active) drug. Treatment will be given orally on days 1-28 of a 28 day cycle.

WA Trial Sites

Sir Charles Gairdner Hospital logo

Haematology Care Centre
Sir Charles Gairdner Hospital
Ph. (08) 9346 4376
Fax (08) 9346 4432
Email: louise.hay@health.wa.gov.au

Links

US National Library of Medicine

 

 

CLL5 Trial 

Registered Title

An Australian, phase II, multicentre, randomised, dose intensification study investigating oral fludarabine, oral cyclophosphamide and i.v. rituximab (poFCivR) tolerance in previously untreated elderly (>65 years old) patients with chronic lymphocytic leukaemia (CLL).

Purpose

To investigate the safety and tolerability of fludarabine, cyclophosphamide, and rituximab in previously untreated elderly (=65years old) patients with CLL.

Lay Summary

During the past few years some new drugs that work against CLL cells have been developed. One of these is Rituximab. Unlike normal chemotherapy, rituximab works by attaching itself specifically to the leukaemia cells and destroying the cells with the help of the body's own immune system.

In other types of cancer, rituximab has already become a standard component of therapy and has been used successfully in many thousands of patients. In CLL, rituximab has been used in several hundred patients worldwide in clinical trials. In these trials it was found that rituximab not only attacks CLL cells but also makes these cells more sensitive to conventional forms of chemotherapy such as fludarabine plus cyclophosphamide. Rituximab is thus able to improve the patients' response to chemotherapy.

This study aims to find out the most effective and well tolerated treatment combination for CLL.

WA Trial Sites

Sir Charles Gairdner Hospital logo

Haematology Care Centre
Sir Charles Gairdner Hospital
Ph. (08) 9346 4376
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) 9346 7615
Fax (08) 9346 4432
Email: nat.eiffler@health.wa.gov.au

Links

Australian New Zealand Clinical Trials Registry

 

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Chronic Myeloid Leukaemia

 

The Australasian RESIST (CML10) Study 

Registered Title

Response Post Tyrosine Kinase Inhibitor: Assessment of Sensitivity and Therapeutic Response to Next-Line Therapy in CML.

Purpose

The aims of the TKI registry are to: collect information about reasons for stopping Tyrosine Kinase Inhibitor (TKI) treatment, to determine the time to stopping TKI treatment and to determine overall survival and progression free survival of patients enrolled onto the TKI registry.

 

The aims of the STOP registry are to: determine the clinical status of patients changing to further treatment, to collect information about selection of further treatment, to collect information about overall survival and progression free survival of patients, to assess the association between patient disease and treatment response with reasons for stoping treatment, too assess the association between patient response and further treatment selected, to determine the rate and success of transplants, to determine the frequency and reasons for stopping treatment, to determining the rate and outcomes of pregnancy and to determine patients' response to further treatment.

Lay Summary

In Australia and New Zealand, an estimated 70 chronic myeloid leukaemia (CML) will stop imatinib and start another therapy or observation each year. The reasons for stopping will include resistance to imatinib, worsening of CML, intolerance to imatinib, other illness and pregnancy. A smaller number will cease Tyrosine Kinase Inhibitor (TKI) treatment and move onto another treatment. The actual frequency of patients stopping TKI treatment, the type of further treatment selected and the outcome of further treatment have not been well studied.

 

This study will consist of two registries and a laboratory study. In order to determine the reasons for and frequency of stopping TKI treatment, a TKI registry of patients with CML on TKI treatment will be set up. The STOP registry will aim to capture data on all consenting patients in Australia and New Zealand who switch or stop their current TKI. All patients on the STOP registry will have regular blood analysis of PCR and mutation done in order to characterise the range of mutations that occur with TKI treatment. Patients who are not pre-registered on the TKI registry will still be eligible for the STOP registry and Correlative studies. The Correlative studies will investigate other tests designed to better predict patient's response to further treatment.

WA Trial Sites

Sir Charles Gairdner Hospital logo

Haematology Care Centre
Sir Charles Gairdner Hospital
Ph. (08) 9346 7615
Fax (08) 9346 4432
Email: nat.eiffler@health.wa.gov.au

 

Fremantle Hospital logo

Fremantle Hospital

Ph. (08) 9431 2729

Links

Australian New Zealand Clinical Trials Registry

 

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Hodgkin's Lymphoma

 

HD8 RTHL Trial 

Registered Title

A Randomised Phase III Trial to Assess Response Adapted Therapy Using FDG-PET Imaging in Patients with Newly Diagnosed, Advanced Hodgkin Lymphoma.

Purpose

This study is designed to test whether a new type of scanning is an effective way to find out how to best treat people with Hodgkin Lymphoma.

Lay Summary

Specifically, the aim of this study is to evaluate the role of PET imaging after 2 cycles of ABVD chemotherapy (standard chemotherapy) in determining a patient's response and further treatment options for patients receiving first-line treatment for advanced Hodgkin lymphoma.

The study aims to identify early in the treatment course those patients for whom switching to a more intensive regimen may be more beneficial.  This study will look at remission rates and toxicity data.

WA Trial Sites

Sir Charles Gairdner Hospital logo

Haematology Care Centre
Sir Charles Gairdner Hospital
Ph. (08) 9346 4376
Fax (08) 9346 4432
Email: louise.hay@health.wa.gov.au

Links

US National Library of Medicine

 

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Non Hodgkin's Lymphoma 

 

GALLIUM B021223

Registered Title

A Multicentre, Phase III, Open-Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101 (RO5072759) plus Chemotherapy Compared With Rituximab Plus Chemotherapy Followed by GA101 or Rituximab Maintenance Therapy In Responders. 

Purpose

This open-label, randomized study will assess the efficacy and safety of RO5072759 (GA101) in combination with chemotherapy compared to MabThera/Rituxan (rituximab) with chemotherapy in patients with untreated advanced indolent non-Hodgkin's lymphoma.

 

Patients will be randomized to receive 6-8 cycles (28 or 21 day cycles) of chemotherapy plus either RO5072759 1000 mg intravenously (iv) on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2 to 6 or 8, or MabThera/Rituxan 375 mg/m2 iv on Day 1 of Cycle 1 to 6 or 8.

 

Patients who respond to treatment will continue to receive monotherapy with either RO5072759 1000 mg iv or MabThera/Rituxan 375 mg/m2 every 2 months until disease progression for up to 2 years. Anticipated time on study treatment is up to approximately 2.5 years. 

Lay Summary

N/A

WA Trial Sites

Royal Perth Hospital logo

RPH Haematology
Ph. (08) 9224 7038

Links

US National Library of Medicine

 

Acknowledgements: US National Library of Medicine

 

GOYA B021005

Registered Title

A Phase III, Multicenter, Open-Label, Randomised Trial Comparing the Efficacy of GA101 (RO5072759) in Combination with CHOP (G-CHOP) versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients with CD20-positive Diffuse Large B-cell Lymphoma (DLBCL).

Purpose

This open-label, randomized, parallel group study will evaluate the efficacy and safety of RO5072759 (GA101) in combination with CHOP chemotherapy versus MabThera/Rituxan (rituximab) with CHOP in previously untreated patients with CD20-positive diffuse large B-cell lymphoma.

 

Patients will be randomized to receive either RO5072759 1000 mg intravenously (iv) every 21 days or MabThera/Rituxan 375 mg/m2 iv every 21 days for 8 cycles, in addition to 6-8 cycles of CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine and prednisolone) iv every 21 days. Anticipated time on study treatment is 24 weeks.

Lay Summary

N/A

WA Trial Sites

Royal Perth Hospital logo

RPH Haematology
Ph. (08) 9224 7038

Links

US National Library of Medicine

 

Acknowledgements: US National Library of Medicine

 

NHL21 Trial - Diffuse Large B-Cell Lymphoma

Registered Title

Early Treatment Intensification With R-ICE Chemotherapy followed by Autologous Stem Cell Transplantation for Patients with Poor Prognosis Diffuse Large B-Cell Lymphoma (DLBCL) as Identified by Interim PET/CT Scan Performed After Four Cycles of R-CHOP-14 Chemotherapy.

Purpose

To see whether more intense treatment for patients with advanced stage disease who have a positive mid-treatment PET scan after four cycles of standard chemotherapy can improve their survival free from lymphoma.

Lay Summary

DLBCL is the most common type of non-Hodgkin lymphoma (NHL). It responds well to chemotherapy and about two thirds of patients will be cured with a combination of CHOP chemotherapy and a drug called rituximab (R-CHOP). There have been attempts to improve the number of patients cured of their DLBCL and one of the treatments is to perform an autologous stem cell transplant (ASCT). ASCT uses higher doses of chemotherapy to kill the lymphoma cells. However, it has been hard to predict which patients are more likely to relapse and therefore potentially benefit from the stronger treatment with ASCT. In recent years, PET (Positron-Emmission-Tomography) scans have proved very useful in this regard. PET scans should go from positive to negative when lymphoma is treated with R-CHOP. This study aims to perform a PET scan after 4 cycles of R-CHOP and those patients with a positive PET scan will go on to have the stronger treatment with ASCT. Those with a negative PET scan will complete treatment with R-CHOP. The expectation is that this "targeted" use of ASCT for patients with a positive PET scan will improve the cure rate.

WA Trial Sites

Sir Charles Gairdner Hospital logo

Haematology Care Centre, Sir Charles Gairdner Hospital
Ph. (08) 9346 4376
Fax (08) 9346 4432
Email: louise.hay@health.wa.gov.au

Links

Australian New Zealand Clinical Trials Registry

 

 

 NHL24 Trial - Primary Central Nervous System Lymphoma 

Registered Title

Rituximab in Primary Central Nervous system Lymphoma (PCNSL): A randomized HOVON/ALLG intergroup study.

Purpose

The objective of the current study is to investigate whether the addition of intravenous Rituximab to a standard chemo- and radiotherapy regimen results in improved event-free survival (EFS).

Lay Summary

To find out whether treatment with rituximab is better than treatment without rituximab, participants will be divided into two groups. In order to balance the groups this division will be decided by a chance process. This process is called randomisation. By comparing the two groups it can be found out whether the addition of rituximab improves the effect of treatment and whether it does not disproportionally increase side-effects compared to standard treatment.

WA Trial Sites

Sir Charles Gairdner Hospital logo

Haematology Care Centre, Sir Charles Gairdner Hospital
Ph. (08) 9346 4376
Fax (08) 9346 4432
Email: louise.hay@health.wa.gov.au

Links

N/A

 

 

NHL 25 - REMARC Trial

Registered Title

Double blind randomized phase III study of lenalidomide (revlimid) maintenance versus placebo in responding elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL).

Purpose

The aim of this study is to determine the benefit of lenalidomide maintenance over 2 years in reducing the relapse rate for DLBCL compared to placebo.

Lay Summary

There is a need for improvement in the long term results for treatment of DLBCL with the combination of CHOP chemotherapy and a drug called rituximab (R-CHOP) as a substantial fraction of higher risk patients still relapse from their disease. No data are yet available for lenalidomide in maintenance for DLBCL. The primary objective is to determine the benefit estimated by the progression free survival associated with lenalidomide maintenance compared to placebo in responding patients treated with RCHOP for DLBCL.

WA Trial Sites

Fremantle Hospital Logo

Fremantle Hospital
Ph. (08) 9431 2729

 

Sir Charles Gairdner Hospital Logo

Haematology Care Centre
Sir Charles Gairdner Hospital
Ph. (08) 9346 4376
Fax (08) 9346 4432
Email: louise.hay@health.wa.gov.au

Links

US National Library of Medicine

Australian New Zealand Clinical Trials Registry

 

 Acknowledgements: US National Library of Medicine

 

 

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Multiple Myeloma

 

ADMYRE APL-C-001-09

Registered Title

Randomised, multicenter, open-label, Phase III study of plitidepsin in combination with dexamethasone vs. dexamethasone alone in patients with relapsed/refractory multiple myeloma. 

Purpose

Study of Plitidepsin in combination with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma.

Lay Summary

N/A

WA Trial Sites

Royal Perth Hospital logo

RPH Haematology
Ph. (08) 9224 7038

Links

US National Library of Medicine

 

Acknowledgements: US National Library of Medicine 

 

Amgen Observational Study

Registered Title

An Observational Study of Neutropenia in Subjects Being Treated for Relapsed or Relapsed/Refractory Multiple Myeloma.

Purpose

The aim of the study is to see how often people with myeloma having lenalidomide and dexamethasone have a low white blood cell count, and how this is treated.

Lay Summary

N/A

WA Trial Sites

Royal Perth Hospital logo

RPH Haematology
Ph. (08) 9224 7038

Links

Cancer Help UK

 

Acknowledgements: US National Library of Medicine

 

MM11 Trial

Registered Title

A Phase 3, Multicentre, Randomized, Controlled Study to Determine the Efficacy and Safety of Cyclophosphamide, Lenalidomide and Dexamethasone (CRD) versus Melphalan (200mg/m2) Followed by Stem Cell Transplant in Newly Diagnosed Multiple Myeloma Subjects.

Purpose

This study will test whether treatment with lenalidomide is as safe, and works as well, as the current standard treatment for multiple myeloma.

Lay Summary

Currently most myeloma patients are given some anthracycline-containing chemotherapy (anti-cancer treatment) for 4 - 6 cycles, have their stem cells collected and move on to have high dose chemotherapy (melphalan) and stem cell transplant.

 


In this trial all myeloma patients ready for treatment, will start on lenalidomide and dexamethasone for 4 months, have their stem cells collected and then be randomised (like tossing a coin) to either high dose chemotherapy (melphalan) and stem cell transplant, or 6 months of lenalidomide combined with cyclophosphamide and dexamethasone.

WA Trial Sites

Sir Charles Gairdner Hospital logo

Haematology Care Centre
Sir Charles Gairdner Hospital
Ph. (08) 9346 7615
Fax (08) 9346 4432
Email: nat.eiffler@health.wa.gov.au

Links

US National Library of Medicine

 

 

Multiple Myeloma Retrospective RPH study

Registered Title

A retrospective study of bisphosphonate use, bone density, and osteonecrosis of the jaw in post transplant myeloma patients at Royal Perth Hospital.

Purpose

N/A

Lay Summary

N/A

WA Trial Sites

Royal Perth Hospital logo

RPH Haematology
Ph. (08) 9224 7038

Links

N/A

 

 

Panorama Study

Registered Title

A multicenter, randomized, double-blind, placebo controlled phase III study of panobinostat in combination with bortezomib and dexamethasone in patients with relapsed multiple myeloma.

Purpose

The purpose of this study is to find out whether the combination of panobinostat, bortezomib and dexamethasone is safe and results in a better anti-myeloma activity than bortezomib and dexamethasone alone. The Primary objective of the study is to compare progression-free survival in both treatment groups.

Lay Summary

Panobinostat is a medicine which has not been approved by the Therapeutic Goods Administration (TGA) or any Health Authority for the treatment of people with multiple myeloma. It is a new drug that may slow down the spread of the disease by blocking certain substances needed by the cancer cells. The medicine being tested in this study is currently not "on the market" (available to buy) in any country.

 
Both Bortezomib and dexamethasone are drugs that have been in use for some time to treat patients with multiple myeloma and together are considered to be a treatment that is an effective therapy currently available to patients with this disease. Participation in this study gives an "equal" or 50 % chance of being treated with bortezomib and dexamethasone and panobinostat, or bortezomib and dexamethasone and a placebo.


During one treatment cycle Panobinostat or a panobinostat placebo is taken orally once a day three times a week for two weeks followed by one week off. While receiving panobinostat or a panobinostat placebo, bortezomib and dexamethasone will also be given. Bortezomib will be administered as intravenous infusion twice a week for two weeks followed by one week off and dexamethasone will be given orally on the days of and after bortezomib administration. There are two treatment phases. Treatment phase 1 consists of eight 3 week cycle and treatment phase 2 consists of four 6 week cycles.

WA Trial Sites

Royal Perth Hospital Logo

RPH Haematology
Ph. (08) 9224 7038

Links

US National Library of Medicine

 

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Myelodysplasic Syndrome

 

Exjade in MDS

Registered Title

A Multi-center, Randomized, Double-Blind, Placebo Controlled Clinical Trial of Deferasirox in Patients with Myelodysplastic Syndromes (low/int-1 risk) and Transfusional Iron Overload.

Purpose

The primary purpose of this study is to prospectively assess the efficacy and safety of iron chelation therapy with deferasirox compared to placebo in patients with myelodysplastic syndromes (low/int-1 risk) and transfusional iron overload.

Lay Summary

N/A

WA Trial Sites

Royal Perth Hospital logo

RPH Haematology
Ph. (08) 9224 7038

Links

US National Library of Medicine

 

Acknowledgements: US National Library of Medicine 

 

GIMEMA

Registered Title

Prognostic significance and longitudinal assessment of patient-reported quality of life and symptoms in high-risk myelodysplastic syndromes: a large international, observational study.

Purpose

An observational study of patient-reported quality of life and symptoms in high-risk myelodysplastic syndromes. The purpose of this study is to evaluate the overall well-being and symptom burden due to disease and treatment. As very little evidence is available about how people with high-risk myelodysplastic syndromes live and the extent of how their subjective well-being is affected, the basic goal of this research is to have better insight on this topic in an effort to optimise future treatment plans for people with myelodysplastic syndromes.

Lay Summary

This clinical trial is studying quality of life and symptoms in patients with newly diagnosed myelodysplastic syndromes.

WA Trial Sites

Sir Charles Gairdner Hospital Logo

Haematology Care Centre
Sir Charles Gairdner Hospital
Ph. (08) 9346 7615
Fax (08) 9346 4432
Email: nat.eiffler@health.wa.gov.au

Links

US National Library of Medicine

 

Acknowledgements: US National Library of Medicine 

 

MDS4

Registered Title

A Randomised Phase II study comparing the efficacy of 5azacitidine alone versus combination therapy with lenalidomide and 5azacitidine in patients with higher risk myelodysplastic syndromes (MDS) and low marrow blast count acute myeloid leukaemia (AML).

Purpose

The aim of this research is to test the effectiveness of a combination of two new drugs (lenalidomide and 5azacitidine) in patients with MDS and AML. It will test whether the two drugs together are more effective than 5azacitidine by itself, and also whether it is safe to use the two drugs together without too many side effects.

Lay Summary

Currently the standard care for Myelodysplasia (MDS) in Australia is "Best Supportive Care" which is treatments such as blood transfusions and antibiotics to improve people's quality of life rather than treating the underlying disease. Treatment of Acute Myeloid Leukaemia (AML) may include Best Supportive Care, but some people with AML also have treatment with intense chemotherapy. Previous research internationally has shown that 5azacitidine in MDS and some types of AML can improve people's blood cell counts, improve their quality of life and prolong survival in some people. Also, some trials with lenalidomide have shown positive responses in people with MDS and AML, reducing the need for blood transfusions. It is possible that combining these two drugs will give better results in people with MDS and AML.

WA Trial Sites

Sir Charles Gairdner Hospital Logo

Haematology Care Centre
Sir Charles Gairdner Hospital
Ph. (08) 9346 7615
Fax (08) 9346 4432
Email: nat.eiffler@health.wa.gov.au

Links

Australian New Zealand Clinical Trials Registry

 

Acknowledgements: Australian New Zealand Clinical Trials Registry

 

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Other Haematology Trials

 

EDGE Study

Registered Title

A Phase 3, Randomised, Multi-Centre, Multi-National, Double-Blind Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Once Daily versus Twice Daily Dosing of Genz-112638 in Patients with Gaucher Disease Type 1.

Purpose

The primary objective of this study is to evaluate the efficacy and safety of once daily (QD) versus twice daily (BID) dosing of eliglustat tartrate (Genz-112638) in patients with Gaucher disease type 1 who have demonstrated clinical stability on BID dosing of eliglustat tartrate (Genz-112638). The secondary objective is to evaluate the pharmacokinetics (PK) of Genz-99067 when eliglustat tartrate (Genz-112638) is administered QD and BID in patients with Gaucher disease type 1 who have demonstrated clinical stability on BID dosing of eliglustat tartrate (Genz-112638).

Lay Summary

N/A

WA Trial Sites

Royal Perth Hospital logo

RPH Haematology
Ph. (08) 9224 7038

Links

US National Library of Medicine

 

Acknowledgements: US National Library of Medicine 

 

MEPO Study

Registered Title

Mepolizumab Compassionate Use Supply Program (SB240563.MHE104317)

Purpose

The purpose of this programme is to provide a treatment option to patients with life-threatening Hypereosinophilic Syndrome (HES) whose symptoms are not controlled with other therapies and to provide continued access to mepolizumab for subjects who received clinical benefit in Study MHE100901 following termination of the study.

Lay Summary

Eligible patients will receive a supply of Mepolizumab for monthly infusions with up to 10mg/kg (maximum dose 750mg or 10mg/kg if body weight less than 45kg) Mepolizumab IV for an initial three months of treatment. The duration and frequency of additional treatment with Mepolizumab will be determined based on the subject's response to the initial three months of treatment as demonstrated by significant lowering of eosinophil level and/or decreased signs and symptoms of HES.

WA Trial Sites

Sir Charles Gairnder Hospital Logo

Haematology Care Centre
Sir Charles Gairdner Hospital
Ph. (08) 9346 4376
Fax (08) 9346 4376
Email: louise.hay@health.wa.gov.au

Links

US National Library of Medicine

 

Acknowledgements: US National Library of Medicine 

 

PNH Registry

Registered Title

Paroxysmal Nocturnal Hemaglobinuria (PNH) Registry: A prospective, multi-centre, multi-national, non-interventional study (no procedures or tests) designed to capture safety and effectiveness data for eculizumab, as well as to compile data on the natural history and management of patients with PNH.

Purpose

To enhance the understanding of PNH demographics and natural history.


To capture the long-term outcomes of patients in order to better guide and assess therapeutic interventions and the safety of eculizumab.


To serve as a global resource for PNH information.

Lay Summary

The registry will enrol patients treated with eculizumab for any reason, as well as patients with PNH. Clinical data will be collected from patients enrolled in this study. Participants will also be required to complete six monthly quality of life questionnaires.

WA Trial Sites

Sir Charles Gairdner Hospital Logo

Haematology Care Centre,
Sir Charles Gairdner Hospital         
Ph. (08) 9346 4376
Fax (08) 9346 4432
Email: louise.hay@health.wa.gov.au

 

Royal Perth Hospital Logo

RPH Haematology
Ph. (08) 9224 7038

Links

PNH Registry website

 

Acknowledgements: US National Library of Medicine