Research and advocacy
Trials Enabling Program
The Trials Enabling Program (TEP) gives people with blood cancer access to promising new drugs through international clinical trials before they’re available in Australia.
Trial participants receive the new drug(s) at no cost and can participate while staying in Australia – they do not need to travel overseas. However, they still need to pay for their normal/standard healthcare costs.
This innovative program provides alternative treatment pathways for patients who have exhausted standard treatment options. It is funded through community support and enables people with blood cancer to access new therapies often years before they are available through our healthcare system.
The program is a partnership between the Leukaemia Foundation and our nation’s leading blood cancer clinical trial group – the Australasian Leukaemia & Lymphoma Group (ALLG).
We were the first Australian charity to establish a grant partnership to help patients access international blood cancer clinical trials. As a result, around 900 Australians have accessed new and potentially life-saving treatments through TEP over the past 10 years.
Current blood cancer trials
CLL12 AETHER Trial
Led by the HOVON CLL Study Group in the Netherlands
This Phase II study is testing a combination of venetoclax and epcoritamab in people with relapsed or treatment-resistant chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). The trial will involve 90 participants across the Netherlands, Germany, Denmark and Australia. Australia will recruit 12 patients across three centres over two years.
MM24 Amyloidosis Trial
Run by the Australasian Leukaemia & Lymphoma Group in partnership with the French group Intergroup Francophone du Myélome
This Phase II international study is testing the effectiveness and safety of isatuximab, pomalidomide and dexamethasone (IPd) in people with AL amyloidosis who haven’t reached a Very Good Partial Response (VGPR) after previous treatment. The trial will recruit 46 patients over nine months at 18 sites in France and Australia, with Australia contributing 12 patients across at least four sites.
If you’d like to participate in one of these trials, please speak to your haematologist.
For more information about these clinical trials, please contact the ALLG on [email protected].
Frequently asked questions
Many Australians have to pay for their travel and medical expenses to participate in overseas trials.
Thanks to TEP, eligible patients with blood cancer can participate in international trials and access cutting-edge drugs and treatments not currently available in Australia. People involved in a clinical trial will receive the new drug(s) at no cost, but will need to pay their normal healthcare costs. They can also participate while staying in Australia and will not need to travel overseas.
Some clinical trials may provide better outcomes than standard treatments and can potentially save lives. Through their participation, patients contribute to and help improve cancer care for patients in the future. If a new treatment has been tested and found to be effective through a clinical trial, it can be approved and made available to help more people.
Please talk to your treating doctor if you’d like to participate in one of these trials. They can assess your case to ensure it is the right treatment option for you.
Your participation in a trial will depend on you meeting certain criteria.
The ALLG manages the trials. For more details about a specific trial, please contact them on [email protected] or visit www.allg.org.au.
Trials available in Australia are run specifically to help Australians with blood cancer now and in the future. Many large international clinical trials are also underway across the world, but these are unavailable in our country due to high establishment and running costs.
By collaborating internationally, clinical trials can be completed faster and results will be known sooner. This can shorten the road to finding a cure.
Minimum participant numbers are needed to assess if a new treatment is effective. By including Australian patients, doctors and researchers in other countries can access enough patients to successfully test and validate new treatments.
Yes. The blood cancer clinical trials conducted via the special Leukaemia Foundation and ALLG partnership are all approved by a medical advisory board, an independent safety board, relevant regulatory authorities (Therapeutic Goods Administration, Australia) and hospital ethics committees.
The process is extensive and rigorous to ensure people participating in these trials are safe and monitored frequently for effects and the effectiveness of the new drug(s).
The Leukaemia Foundation and the nation’s leading clinical trial group for blood cancer, ALLG, deliver the trials program. As the facilitators of the program, ALLG works with haematologists to manage the delivery of the international clinical trials to Australians, and administration and data collection. A scientific committee at ALLG identifies suitable trials.
The Leukaemia Foundation’s role is to find consistent funding to ensure as many patients as possible can benefit from the program.
Find out how you can support this program.
New cancer drugs currently under development are tested through clinical trials. These studies help determine whether a new drug or treatment option is safe and effective.
Each clinical trial has a plan (protocol) that maps out the procedures of the study – what will be done, by who, when and why. The protocol also explains who is eligible to participate and what is expected of each person.
Clinical trial participants are managed by a team of doctors and nurses.
There are three types of clinical trials and each one is associated with a different phase in the development of a new medicine or treatment.
Phase 1: Determines the safety of the medicine, how it works and how well it is tolerated in small groups of people.
Phase 2: Determines the effectiveness of the medicine and further evaluates the safety in a larger group of people.
Phase 3: Determines the effectiveness, monitors side effects and compares it to commonly used treatments in large groups of people.
Any patient from a metropolitan, rural, regional or remote area who meets the criteria can participate.
The Trials Enabling Program is the first time an Australian charity has established a grant partnership to help Australian patients access international blood cancer trials.
There is no cost for patients to access the drugs and therapies through the clinical trials. Medical tests and medical care related to the trial are also provided at no cost. However, patients will have to pay for their standard healthcare costs.
The Leukaemia Foundation through TEP, with community support, will cover the trial access costs (including the transportation and logistics of getting the drugs from overseas, and operating the clinical trials at treatment centres across Australia) so patients can access the clinical trial treatment and/or drug.
The program’s success relies on having a consistent funding source to ensure as many patients as possible can access the trials.
The Leukaemia Foundation relies on the generous support of the community to make new treatment options a reality for as many blood cancer patients as possible.
You can donate over the phone or securely on our website.
Make your donation to make a difference for someone living with blood cancer.
Unfortunately, no. The program was established to ensure as many Australian blood cancer patients can benefit from a trial as possible. To achieve this, a scientific committee at ALLG identifies suitable international trials.
The Leukaemia Foundation is committed to beating blood cancers. Each clinical trial operates as a separate research study (good ethical and regulatory rules require this). We will continue to fundraise to ensure as many patients can benefit from the clinical trials as possible.
Every day, 55 Australians are diagnosed with a blood cancer such as leukaemia, lymphoma or myeloma. While there has been remarkable progress in the development of new blood cancer treatments, every 80 minutes someone still loses their life to a blood cancer.
While continuing investments across all streams of research, the Leukaemia Foundation believes additional support for clinical trials is necessary to fast-track the delivery of new drugs and therapies to improve outcomes for blood cancer patients.
As well as being reviewed by government authorities such as the Therapeutic Goods Administration, the results of a clinical trial may be reported in the medical press. The results are published so that doctors can make scientifically valid assessments of the risks and benefits of a new medicine.
Although the results are published, nothing that identifies individual patients will be released. Clinical trial participants are de-identified for the purpose of the research data.
The results are used by doctors to advocate for new drugs to be made available to the Australian community. This data provides crucial evidence so government bodies can be certain that a new drug is better, safer and superior when compared to what is currently on offer.
For more information about TEP, the coordination of trials or details about patient recruitment, please contact the ALLG on [email protected] or visit www.allg.org.au
To donate to the Trials Enabling Program, please contact the Leukaemia Foundation on 1800 620 420 or donate online.
Previously completed TEP trials include:
- Clinical trial for primary myelofibrosis
- Clinical trial for advanced stage Hodgkin lymphoma
- Clinical trial for high tumour burden follicular lymphoma
- Clinical trial for newly diagnosed AML or MDS with IDH1 or IDH2 mutation
- Clinical trial for newly diagnosed AML or MDS with FLT3 mutation