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RecruitingLast updated: 18 April 2024

AMLM25: This phase II trial is investigating different chemotherapy combinations for the treatment of elderly patients that have Acute Myeloid LeukaemiaAn ALLG Phase 2 study to Investigate Novel Triplets to Extend Remission with VENetoclax in Elderly (INTERVENE) Acute Myeloid Leukaemia

Clinical summary

Summary

This trial includes a dose finding Run-in phase and a randomised phase. Eligible patients enrolled in the Run-in phase of the trial will received Low dose cytarabine (LDAC) and venetoclax, in combination with either midostaurin OR pracinostat to determine a recommended phase 2 dose. Eligible patients enrolled in the randomised phase of the trial will receive LDAC and venetoclax alone, or in combination with either midostaurin OR pracinostat at the recommended phase 2 dose.

Conditions

This trial is treating patients with acute myeloid leukaemia

Cancer

Blood Cancers Haematological

Age

People60+

Phase

II

Trial Acronym

AMLM25

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Medical Research Future Fund,Australasian Leukaemia and Lymphoma Group (ALLG)

Scientific Title

An ALLG Phase 2 study to Investigate Novel Triplets to Extend Remission with VENetoclax in Elderly (INTERVENE) Acute Myeloid Leukaemia

Eligibility

Inclusion

- Age, greater than or equal to 60 years.
- AML (excluding acute promyelocytic leukaemia and core binding factor AML) stratified by MRC 2010 criteria
a. Non-adverse cytogenetic risk or
b. Adverse cytogenetic risk (inclusive of failed cytogenetic analysis)
- ECOG performance status 0-2
- No prior treatment for AML (except hydroxyurea or thioguanine)
- Adequate liver function (AST or ALT less than 1.5x ULN and bilirubin les than or equal to 1.5x ULN*). *unless considered related to AML or Gilbert’s syndrome
- Adequate renal function as demonstrated by a Cockcroft Gault formula creatinine clearance of greater than 30mL/min.

Exclusion

- Any serious medical, psychological or social problem which the investigator feels may interfere with the procedures or evaluations of the study including:
a. Malabsorption syndrome or other condition that precludes enteral route of administration
b. Significant cardiovascular disability status of New York Heart Association Class greater than 2.
c. Significant chronic respiratory disease that requires continuous oxygen
- WBC greater than 25x109/L. Hydroxyurea may be used to control the white blood cell count
- Acute promyelocytic leukaemia
- Core binding factor AML including t(8;21)(q22;q22) or inv(16)(p13. 1q22)/t(16;16)(p13.1;q22)
- Antecedent chronic myeloid leukaemia (CML) or CML in blast phase
- Antecedent myelofibrosis (including primary and secondary)
- Active CNS leukaemia
- Prior exposure to venetoclax, FLT3 inhibitors or pracinostat
- Exposure to other investigational agents within 30 days or 5 half lives
- Known hypersensitivity to any of the investigational agents
- History of other malignancy requiring active systemic treatment or which is likely to result in an expected survival time of less than 2 years
- Subject is known to be positive for HIV
- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
a. Clinically significant active systemic infection (viral, bacterial or fungal) requiring therapy
b. Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate
- Active bleeding or clinically relevant prolongation of APTT or INR
- QT-interval corrected according to Fridericia’s formula (QTcF) greater than 450ms
- Treatment with any of the following within 7 days prior to the first dose of study drug
a. Steroid therapy for anti-neoplastic intent
b. Moderate or strong cytochrome P450 3A (CYP3A inhibitors)
c. Moderate or strong CYP3A inducers
- Administration or consumption of any of the following within 3 days prior to the first dose of study drug:
a. Grapefruit or grapefruit products
b. Seville oranges (including marmalade containing Seville oranges)
c. Star fruit
- (For Pracinostat containing arm only) Current smokers (use of patches, chewing gums or vaping nicotine containing fluids is permitted). Patients who stopped smoking at least 8 days prior to first pracinostat dosing can be enrolled, provided they refrain from smoking during the whole study.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for at least 4 months after stopping medication. Highly effective contraception methods include:
a. Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
b. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
c. Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that subject
d. Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system, or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
e. In case of use of oral contraception women should also add a barrier method of contraception, particularly as it is currently unknown whether midostaurin may reduce the effectiveness of hormonal contraceptives.
f. Sexually-active males unless they use a condom during intercourse with females of reproductive potential or pregnant women and for at least 4 months after stopping treatment to avoid conception or embryo-fetal harm.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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