Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

PREACH-M : 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.

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaLeukaemia

Trial Overview Read MoreRead more

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).
 

This trial is treating patients with chronic myelomonocytic leukaemia.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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

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.

Other Non-Commercial Sponsor

South Australian Health & Medical Research Institute Ltd

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).

Recruiting Hospitals Read MoreRead more

Austin Health
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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