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RecruitingLast updated: 2 February 2024

PREACH-M: This phase II trial is trying to understand whether treatment responses for people with Chronic Myelomonocytic Leukaemia can be improved by targeting certain gene mutations with certain cancer drugs (such as lenzilumab, azacitidine and sodium ascorbate)Precision Medicine for Chronic Myelomonocytic Leukaemia in Adults: A phase II Trial Studying the Efficacy of Lenzilumab and High Dose Ascorbate with Azacitidine Based on Molecular Profiling.

Clinical summary

Summary

This is a non-randomised, open trial investigating precision medicine for adults with Chronic Myelomonocytic Leukaemia (CMML). As part of the screening process, participants will be required to have a bone marrow aspirate and trephine to test for certain acquired mutations that can be present in CMML. The study is looking for participants with TET2 and/or RAS pathway mutations. Participants with TET2 mutations will receive azacitidine (administered subcutaneously at a dose of 75mg/m2 on days 1-5, 8-9 or days 1-7 for a total of 7 doses per 28-day cycle) in combination with sodium ascorbate (administered intravenously at a dose of 30g on days 1-5, 8-9 or days 1-7 [15g for 1st dose only, 30g thereafter if no evidence of tumour lysis syndrome]). Participants in this cohort will also self-administered sodium ascorbate (orally at a dose of 1.1g) at home on days where intravenous sodium ascorbate is not scheduled. Participants with RAS pathway mutations or both TET2 and RAS mutations, will receive azacitidine (administered subcutaneously at a dose of 75mg/m2 on days 1-5, 8-9 or days 1-7 for a total of 7 doses per 28-day cycle) in combination with lenzilumab (administered intravenously at a dose of 552mg on days 1 & 15 of Cycle 1. Day 1 only for all subsequent cycles).

Conditions

This trial is treating patients with chronic myelomonocytic leukaemia

Cancer

Blood Cancers Haematological

Age

People18+

Phase

II

Trial Acronym

PREACH-M

More information

Trial Identifiers

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Trial sponsor

South Australian Health & Medical Research Institute Ltd

Scientific Title

Precision Medicine for Chronic Myelomonocytic Leukaemia in Adults: A phase II Trial Studying the Efficacy of Lenzilumab and High Dose Ascorbate with Azacitidine Based on Molecular Profiling.

Eligibility

Inclusion

1. Confirmed diagnosis of CMML, including t-CMML, satisfying the WHO 2016 criteria
2. Aged 18 or older
3. Cytopenia, constitutional symptoms or proliferative CMML (white blood cell count >=13
x10^9/L)
4. Detection of TET2 mutation or NRAS/KRAS/CBL mutation at a variant allele frequency
of >=3%. Participants who are found to have both TET2 and RAS pathway mutations will
be allocated to the lenzilumab/azacitidine arm of the study.
5. Eastern Cooperative Oncology Group (ECOG) performance status of <=2.
6. Based on known non-CMML related medical history, expected to have a life
expectancy of >= 24 months.
7. Must have the following local laboratory results:
a. Liver function (total bilirubin <=1.5* x upper limit of normal [ULN], aspartate
aminotransferase [AST] and alanine aminotransferase [ALT] <=3 x ULN). For
participants with hepatomegaly due to extramedullary haematopoiesis, AST
and/or ALT must be < 5 x ULN. *For participants with total bilirubin >1.5 x ULN,
direct bilirubin must be <= ULN.
b. Kidney function: creatinine clearance >30 mL/min using Cockcroft-Gault formula.Note:
the Adjusted Body Weight formula should be used for participants with a BMI of = 30.
Actual Body weight should be used when BMI is < 30.
8. Ability to understand the requirements of the study and informed consent.
9. Reproductive status
a. Women of childbearing potential (WOCBP) must have a negative serum or urine
pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24
hours prior to the start of study drug
b. Women must not be breastfeeding
c. WOCBP must agree to follow instructions for method(s) of contraception for the
duration of treatment with study drug, plus 30 days (duration of ovulatory cycle) for a total of 30 days post-treatment completion
d. Men who are sexually active with WOCBP must agree to follow instructions for
method(s) of contraception for the duration of treatment with study drug plus 90
days (duration of sperm turnover) for a total of 90 days post-treatment
completion.

Exclusion

1. Prior hypomethylating or intensive cytotoxic treatment for CMML except for
hydroxyurea. Hydroxyurea may be given prior to starting active protocol treatment
and during the first 14 days of Cycle 1 only
2. Prior treatment with an investigational agent, or radiotherapy within 28 days before
Cycle 1 Day 1 (or within 5 half-lives of the investigational agent, whichever is longer).
Participants must have recovered from the toxic effects of that therapy to <= Grade 1 or
baseline grade.
3. Major surgery within 2 weeks or having not recovered from surgery.
4. Treatment with G-CSF within 7 days of screening or GM-CSF within 28 days of
screening.
5. Serious medical or psychiatric illness likely to interfere with participation in this clinical
study
6. Other concurrent uncontrolled medical conditions. These include, but are not limited
to: uncontrolled diabetes, uncontrolled infections, acute or chronic liver and renal
disease, uncontrolled cardiovascular conditions, including ongoing cardiac arrhythmias
(e.g. ventricular arrhythmias or Torsades de Pointes, or third-degree heart block without
pace maker insertion) or uncontrolled congestive cardiac failure.
7. Myocardial infarction or clinically significant pericardial effusion within the past month.
8. Another primary malignant disease that requires active treatment. Basal or squamous cell skin carcinomas adequately treated are allowed.
9. Acute or chronic liver disease (including chronic hepatitis B and C infections). Hepatitis B Virus core antibody positivity is not an automatic exclusion.
10. Patients with known active Hepatitis A infection. Testing for Hepatitis A is not required as part of screening for this study.
11. Participants with known human immunodeficiency viruses (HIV). Screening for HIV is not required for this study.
12. Participants who are unable to comply with requirements for contraception as per study requirements.
13. Prior allogeneic stem cell transplantation.
14. Current participation in another therapeutic clinical trial (participation in clinical trials that do not involve active interventions is not an exclusion for the study).

Inclusion

  • You are able to swallow medication by mouth.

Exclusion

  • 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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