Acute Leukaemias

Clinical trials for patients with acute leukaemia. Acute Leukaemia is a type of cancer that affects the blood and bone marrow.

If you would like to be considered for a clinical trial you will require a referral from your current treating team. Visit the Joining a Clinical Trial page for referral information. 

For more information on clinical trials, get in contact with our cancer clinical trials enquiry coordinator.

Clinical Trials Enquiry Coordinator

Business hours, Mon to Friday between 9am - 2pm
Email Clinical Trials Enquiries
Phone (03) 8559 7456

Open and Recruiting Clinical Trials

A phase Ib clinical evaluation of Venetoclax in combination with chemotherapy in older patients with AML

Cancer type

Acute myelogenous leukaemia

Status

Open and recruiting

Phase

One: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one clinical trial is to test the safety of the new treatment and find the best dose to give patients.

Brief summary

A clinical trial to test the safety and effectiveness of the treatment Venetoclax in combination with chemotherapy (Cytarabine and Idarubicin) in patients over 60 years old who have been diagnosed with acute myelogenous leukaemia.

Venetoclax is a type of treatment that targets BCL2, a protein which helps control whether a cell lives or dies by a process called apoptosis. BCL2 changes can protect cancer cells from dying when being treated with anti-cancer treatments. Ventoclax is given as a tablet. Cytarabine and Idarubicin are standardly used to treat acute myelogenous leukaemia. Both drugs are given by an infusion into the vein and require the patient to be an inpatient during the infusions.   This combination of treatments is expected to work together to kill cancer cells and induce remission.

Who can participate
  • Have acute myelogenous leukaemia diagnosis
  • Are over 60 years old
  • Have not received treatment for their cancer (acute myelogenous leukaemia)

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

Study of using Cyclophosphamide After Sibling-donor allogeneic stem-cell Transplantation (CAST) in patients with acute leukaemia and myelodysplasia: a randomised study comparing cyclosporin and methotrexate to cyclosporin and post-transplantation cyclophosphamide for graft-versus-host disease prophylaxis

Trial ID

ACTRN12618000505202

Cancer type

Acute leukaemia and myelodysplasia (MDS)

Status

Open and recruiting

Phase

Three: A phase three clinical trial follows a phase two, in a larger group of patients with specific cancer types. The aim of a phase three is to compare the new treatment to existing treatments available for that cancer type.

Brief summary

A clinical trial to test if the treatment combination cyclosporin and post-transplant cyclophosphamide is better than the standard treatment given for acute leukaemia and myelodysplasia cancer to prevent graft-versus-host disease (GVHD).

The treating doctor has recommended allogeneic stem cell transplant, where stem cells given use the donor’s (sibling) immune system to destroy cancer cells. A complication of allogeneic stem cell transplant is GVHD, where the donor’s immune cells do not recognise the recipient’s body as foreign and attack the body (similar to when the immune system fights a virus / infection). The standard treatment given to prevent GVHD is the combination of cyclosporin and methotrexate (chemotherapy treatment) given following transplant. Cyclosporin is taken orally and cyclophosphamide is given as an infusion into the vein.

Patients will be randomly selected to receive one of the following treatment combinations:

Arm A: Cyclosporin and post-transplant cyclophosphamide

Arm B: Post-transplant cyclosporin and methotrexate

Who can participate
  • Are between 18 and 70 years old
  • Have acute leukaemia and myelodysplasia

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

A Phase 1 First-In-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG427 in Subjects With Relapsed / Refractory Acute Myeloid Leukemia

Trial ID

NCT03541369

Cancer type

Acute myeloid leukemia

Status

Open and recruiting

Phase

One: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one clinical trial is to test the safety of the new treatment and find the best dose to give patients.

Brief summary

A clinical trial to test the safety and effectiveness of the new treatment AMG427 in patients with acute myeloid leukemia that has come back after treatment or not responded to treatment given. The clinical trial has two parts, the first will find the best dose of AMG427, the second will test AMG427 in a larger group of patients to further test the safety and effectiveness of the treatment. AMG427 is given as an infusion into the vein

AMG427 is a type of treatment that works with the body’s immune system to attack and kill cancer cells in your blood. This is the first time AMG427 will be given to people.

Who can participate

Patients who:

  • Have not responded to one or more treatments given
  • Haven’t undergone autologous stem cell transplant (patient’s own stem cells, taken before treatment, are given to restore bone marrow and immune system after high dose chemotherapy) within 6 weeks prior to participation
  • Haven’t undergone allogeneic stem cell transplant (stem cells given use the donor’s immune system to destroy cancer cells) within 3 months prior to participation

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 673 Administered as Short Term Intravenous Infusions in Subjects with Relapsed/Refractory Acute Myeloid Leukemia

Trial ID

NCT03224819

Cancer type

Acute myeloid leukemia

Status

Open and recruiting

Phase

One: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one clinical trial is to test the safety of the new treatment and find the best dose to give patients.

Brief summary

The aim of the clinical trial is to test the safety (side effects) and effectiveness of the new treatment AMG 673 in patients with acute myeloid leukemia that has come back after treatment or not responded to treatment given. AMG673 is given as an infusion into the vein

Acute myeloid leukaemia is a type of cancer where the bone marrow produces too many immature white blood cells, which can cause cancer to grow and spread quickly. AMG 673 is a type of treatment called a BiTE® antibody made in a laboratory. An antibody is a protein made by the body as part of the immune response to a foreign substance (such as bacteria, virus / infection). AMG 673 works by helping your immune system to target and attack cancer cells in the blood.

Who can participate

Patients who:

  • Have acute myeloid leukaemia
  • Haven’t undergone autologous stem cell transplant (patient’s own stem cells, taken before treatment, are given to restore bone marrow and immune system after high dose chemotherapy) within 6 weeks prior to participation
  • Haven’t undergone allogeneic stem cell transplant (stem cells given use the donor’s immune system to destroy cancer cells) within 3 months prior to participation

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

The International AML Platform Consortium (IPAC) trial is a randomised, multi-arm study platform to compare the efficacy of experimental therapies versus standard of care in patients with acute myeloid leukaemia in first complete remission

Trial ID

ACTRN12619000248167

Cancer type

Acute myeloid leukemia

Status

Open and recruiting

Phase

Two: A phase two clinical trial follows a phase one, in a large group of patients with selected cancer types. The aim of a phase two is to find out if the new treatment is effective in these cancer types.

Brief summary

The aim of the clinical trial is to test different and new maintenance treatments in patients with acute myeloid leukaemia, in their first remission to reduce or eliminate minimal residual disease (MRD) and reduce the risk of the leukaemia returning. MRD is very small amounts of leukaemia that can remain in the bone marrow / blood after treatment and can only be detected using a special blood or blood marrow test.

This type of clinical trial is called a platform clinical trial, which aim to provide a number of treatment options to find the best treatment pathway for patients with acute myeloid leukaemia. Patients will be randomly selected into a treatment arm

The two treatment options currently available:

Arm 1: Molibresib will be compared against the standard treatment given for acute myeloid leukaemia. Molibresib is a type of treatment called a Bromodomain and extraterminal domain (BET) inhibitor. BET are proteins that can play a role in the growth of some cancers. BET inhibitors work by stopping BET changes that can cause increased growth of cancer cells. The standard of care treatment is clinical observation. Molibresib is given in tablet form and taken by mouth.

Arm 2: Venetoclax given alone and in combination with low dose cytarabine (LDAC) will be compared against the standard treatment given for acute myeloid leukaemia. Venetoclax is a type of treatment that targets BCL2, a protein which helps control whether a cell lives or dies by a process called apoptosis. BCL2 changes can protect cancer cells from dying when being treated with anti-cancer treatments. Cytarabine is a type of chemotherapy. The standard of care treatment is clinical observation. Venetolclax is given in tablet form and taken by mouth and cytarabine given in liquid form, by small injection under the skin.

Who can participate

Patients who:

  • Have acute myeloid leukaemia, in first remission after treatment with intensive chemotherapy

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Victorian Cancer Clinical Trial Registry.

A phase 2 study of Venetoclax in combination with low-dose cytarabine in relapsing acute myeloid leukaemia

Trial ID

NCT03069352

Cancer type

Acute myeloid leukemia

Status

Open and recruiting

Phase

Two: A phase two clinical trial follows a phase one, in a large group of patients with selected cancer types. The aim of a phase two is to find out if the new treatment is effective in these cancer types.

Brief summary

A clinical trial to test if the treatment Venetoclax given in combination with low dose Cytarabine (LDAC) is safe and better than the standard treatment given for acute myeloid leukaemia.

A clinical trial to test the safety and effectiveness of the treatment Venetoclax in combination with low dose Cytarabine (LDAC) in patients with acute myeloid leukaemia.

Venetoclax is a type of treatment that targets BCL2, a protein which helps control whether a cell lives or dies by a process called apoptosis. BCL2 changes can protect cancer cells from dying when being treated with anti-cancer treatments. LDAC is a type of chemotherapy and standard treatment given to patients with acute myeloid leukaemia.  Venetoclax is given as a tablet by mouth and cytabarine is given in liquid form, by small injection under the skin.

Patients will be randomly selected to receive one of the following treatments:

Arm A: Venetoclax given with LDAC

Arm B: Placebo (pill/liquid that contains no active treatment) given with LDAC

Who can participate

Patients who:

  • Are between 18 and 75 years of age
  • Have acute myeloid leukaemia

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

Phase II Study of Blinatumomab as Induction Therapy in Adolescent and Young Adult Acute Lymphoblastic Leukaemia

Trial ID

ACTRN12618001734257

Cancer type

Acute lymphoblastic leukaemia

Status

Open and recruiting

Phase

Two: A phase two clinical trial follows a phase one, in a large group of patients with selected cancer types. The aim of a phase two is to find out if the new treatment is effective in these cancer types.

Brief summary

A clinical trial to test if the treatment Blinatumomab can improve outcomes for patients with acute lymphoblastic leukaemia. Blinatumomab is a type of treatment called immunotherapy, which works with your immune system to help destroy cancer cells or stop them growing. Blinatumomab given in liquid form, by injection that runs for several days via a small portable pump: the pump can be worn at home as well as in hospital.

Blinatumomab  has shown to be effective for patients with acute lymphoblastic leukaemia who have not responded or the cancer has come back after initial treatment. Blinatumomab has also shown to be effective in eliminating minimal residual disease (MRD). MRD is very small amounts of leukaemia that can remain in the bone marrow / blood after treatment and can only be detected using a special test. In children, finding MRD at certain points in acute lymphoblastic leukaemia treatment can help predict whether a patient might be cured with standard treatment or might need more intensive treatment to improve their outcome.

Who can participate

Patients who:

  • Are between 15 and 40 years old

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

A Phase 1 First in Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 176 in Subjects With Relapsed or Refractory Multiple Myeloma and Subjects With Relapsed or Refractory Acute Myeloid Leukemia

Trial ID

NCT02675452

Cancer type

Multiple myeloma and acute myeloid leukemia

Status

On hold

Phase

One: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one clinical trial is to test the safety of the new treatment and find the best dose to give patients

Brief summary

A clinical trial to test the safety and effectiveness of the new treatment AMG 176 in patients with multiple myeloma and acute myeloid leukemia who have not responded to or cancer has come back after treatment given.

AMG 176 is a type of treatment called MCL-1 inhibitor. MCL-1 is a protein that helps control whether a cell lives or dies by a process called apoptosis. MCL-1 changes can protect cancer cells from dying when receiving anti-cancer treatments. AMG 176 works by stopping MCL-1 changes in cancer cells causing them to die. AMG 176 is given in liquid form, by injection into your vein.

The clinical trial has 4 parts:

Part 1: Aim find the best dose of AMG 176 in patients with multiple myeloma

Part 2: AMG 176 given in combination with Carfilzomib and dexamethasone in patients with multiple myeloma. Carfilzomib is given in liquid form, by injection into your vein and dexamethasone can be taken in tablet form by mouth or liquid form by small injection under the skin.

Part 3: Aim find the best dose of AMG 176 in patients with acute myeloid leukemia

Part 4: AMG 176 given in combination with azacitidine in patients with acute myeloid leukemia. Azacitidine is given in liquid form by small injection under the skin.

Who can participate

Patients who:

  • Have multiple myeloma or acute myeloid leukemia that has not responded to or cancer has come back after at least two lines of treatment
  • Haven’t undergone autologous stem cell transplant (patient’s own stem cells, taken before treatment, are given to restore bone marrow and immune system after high dose chemotherapy) within 90 days prior to participation
  • Haven’t undergone allogeneic stem cell transplant (stem cells given use the donor’s immune system to destroy cancer cells) within 6 months prior to participation

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

An International Phase Ib multicentre study to characterize the safety and tolerability of intravenously administered S64315, a selective Mcl-1 inhibitor, in combination with orally administered Venetoclax, a selective BCL-2 inhibitor, in patients with Acute Myeloid Leukaemia (AML)

Trial ID

NCT03672695

Cancer type

Acute myeloid leukemia

Status

Open and recruiting

Phase

One: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one clinical trial is to test the safety of the new treatment and find the best dose to give patients

Brief summary

A clinical trial to test the safety and effectiveness of the new treatment S64315 given with Venetoclax in patients with acute myeloid leukaemia who have has not responded to or cancer has come back after treatment given. S64315 is given in liquid form, by injection into the vein. Venetoclax is given in tablet form, by mouth.

BCL2 and MCL1 are proteins that helps control whether a cell lives or dies by a process called apoptosis. BCL2 and MCL1 changes can protect cancer cells from dying when receiving anti-cancer treatments. Venetoclax and S64315 works by stopping BCL2 and MCL1 changes to kill cancer cells. The clinical trial has two parts, the first will find the best dose of S64315 given with Venetoclax and the second will test the combination in a larger group of patients to further test the safety and effectiveness of the treatment.

Who can participate

Patients who:

  • Have acute myeloid leukaemia who have has not responded to or cancer has come back after treatment given

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian New Zealand Clinical Trial Registry.

An ALLG Phase 2 study to Investigate Novel Triplets to Extend Remission with Venetoclax in Elderly Acute Myeloid Leukaemia

Trial ID

ACTRN12619001655134

Cancer type

Acute myeloid leukemia

Status

Open and recruiting

Phase

Two: A phase two clinical trial follows a phase one, in a large group of patients with selected cancer types. The aim of a phase two is to find out if the new treatment is effective in these cancer types.

Brief summary

A clinical trial to test the safety and effectiveness of low dose Cytarabine (LDAC), Venetoclax, Midostaurin and Pracinostat in patients with acute myeloid leukaemia who are 60 years and older and have not yet been treated for their cancer. Cytarabine is given in liquid form by a small injection under the skin or injection into the vein, venetoclax midostaurin and pracinostat are given in tablet form by mouth.

It is hoped the treatment combination will improve treatment outcomes and increase overall survival.

The clinical trial has two parts:

Part 1: Aim to find the best dose of Midostaurin and Pracinostat when given in combination with Venetoclax and LDAC

Part 2: Aim to compare safety and effectiveness of adding in Midostaurin or Pracinostat to the combination of Venetoclax and LDAC

Who can participate

Patients who:

  • Have not been treated for their cancer
  • 60 years and older

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

A phase 3, multicenter, double-blind, randomized, placebo-controlled study of ivosidenib or enasidenib in combination with induction therapy and consolidation therapy followed by maintenance therapy in patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome with excess blasts-2, with an IDH1 or IDH2 mutation, respectively, eligible for intensive chemotherapy

Trial ID

NCT03839771

Cancer type

Acute myeloid leukemia or myelodysplastic syndrome

Status

Open and recruiting

Phase

Three: A phase three clinical trial follows a phase two, in a larger group of patients with specific cancer types. The aim of a phase three is to compare the new treatment to existing treatments available for that cancer type.

Brief summary

A clinical trial to test if the treatment Ivosidenib or Enasidenib in combination with chemotherapy is safe and better than the standard treatment given for acute myeloid leukemia or myelodysplastic syndrome.

Patients with excess blast cells (immature white blood cells not normally visible in healthy blood) and specific changes in the genes of their cancers (called IDH1 and IDH2) are eligible for this clinical trial. Changes can help the growth of cancer cells and are seen in approximately 20% of patients with newly diagnosed acute myeloid leukemia. Ivosidenib and Enasidenib work by stopping IDH1 and IDH2 changes to reduce the growth of cancer. Ivosidenib and Enasidenib are given in tablet form by mouth.

Patients with IDH1 changes will be randomly selected to receive either:

  • Ivosidenib given with chemotherapy
  • Placebo (pill/liquid that contains no active treatment) given with chemotherapy

Patients with IDH2 changes will be randomly selected to receive either:

  • Ivosidenib given with chemotherapy
  • Enasidenib given with chemotherapy
Who can participate

Patients who:

  • Have excess blast cells (immature white blood cells not normally visible in healthy blood)
  • Have IDH1 or IDH2 changes

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

A Phase 1b Open-label Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Administration of Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (ALL)

Trial ID

NCT04524455

Cancer type

Acute lymphoblastic leukemia

Status

Open and recruiting

Phase

One: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one clinical trial is to test the safety of the new treatment and find the best dose to give patients.

Brief summary

A clinical trial to test the safety and effectiveness of AMG 404 given in combination with Blinatumomab in patients with B cell precursor acute lymphoblastic leukemia that has not responded to or come back after treatment given.

B cell precursor is a fast-growing type of leukemia, with too many B-cell blast cells (immature white blood cells) are found in the bone marrow and blood. It is the most common type of acute lymphoblastic leukemia.

Blinatumomab is a type of treatment called immunotherapy, which works with your immune system to help destroy cancer cells or stop them growing. AMG 404 is a type of treatment called monoclonal antibody. A monoclonal antibody is a type of antibody (protein made by the body as part of the immune response to a foreign substance) produced in a laboratory designed to bind specifically to cancer cells. When used in anti-cancer treatments, the monoclonal antibody delivers the treatment directly to cancer cells. The combination of AMG 404 is expected to work together to increase the treatment outcome of Blinatumomab. Blinatumomab is given in liquid form by injection into the vein over several days using a small pump that can be used at home, as well as in the hospital. AMG 404 in liquid form by injection into the vein.

The clinical trial has two parts, the first will find the best dose of AMG 404 given in combination with Blinatumomab and the second will test the combination in a larger group of patients to further test the safety and effectiveness of the treatment.

Who can participate

Patients who:

  • Have B cell precursor acute lymphoblastic leukemia
  • Have cancer that has not responded to or come back after treatment given

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

An Open-Label, Multi-Center, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7283420 as a Single Agent in Hematologic and Molecular Relapsed/Refractory Acute Myeloid Leukemia

Trial ID

NCT04580121

Cancer type

Acute myeloid leukemia

Status

Open and recruiting

Phase

One: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one clinical trial is to test the safety of the new treatment and find the best dose to give patients.

Brief summary

A clinical trial to test the safety and effectiveness of the new treatment RO7283420 in patients with acute myeloid leukemia that has come back or not responded to treatment given.

RO7283420 is a type of treatment called T-cell bi-specific antibody. An antibody is a protein made by the body as part of the immune response to a foreign substance (such as bacteria, virus / infection). T-cells are also part of the immune system, their job is to kill foreign bodies, like bacteria or infection, and to help B cells produce antibodies. RO7283420 works by blinding to the immune system and leukemia cells at the same time to help the T-cells to recognise and kill leukemia cells. RO7283420 is given in liquid form by injection into the vein.

The clinical trial has two parts, the first will find the best dose of RO7283420 and the second will test RO7283420 in a larger group of patients to further test the safety and effectiveness of the treatment.

Who can participate

Patients who:

  • Have acute myeloid leukemia that has come back or not responded to treatment given

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.