CML12 DIRECT : A single arm phase II study to individualize dasatinib dosing based on trough levels and molecular response to maintain efficacy whilst minimising toxicity in elderly patients with chronic myelogenous leukaemia.

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

60+Age Over 60

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaChronic Myelogenous Leukaemia

Trial Overview Read MoreRead more

This phase II trial is evaluating oral dosing of the drug dasatinib in elderly patients with Chronic Myelogenous Leukaemia (CML).
 

This trial is treating patients with Chronic Myelogenous 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 have been diagnosed with cancer, but have not received any treatment.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

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

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

A single arm phase II study to individualize dasatinib dosing based on trough levels and molecular response to maintain efficacy whilst minimising toxicity in elderly patients with chronic myelogenous leukaemia.

Cooperative Group

Australasian Leukaemia and Lymphoma Group (ALLG)

Summary

The primary purpose of this study is to evaluate the efficacy and safety of individualised dosing of dasatinib for elderly patients with chronic myelogenous leukaemia. Who is it for? You may be eligible to participate in this study if you are aged 60 years or over, and have been diagnosed with chronic myelogenous leukaemia in the chronic phase (CML-CP) in the previous three months. Study details All participants in this study will start taking dasatinib at 100mg per day. At day 7, a blood sample will be taken to measure the levels of dasatinib in the blood just prior to taking that day's dose. If the blood dasatinib level is above a certain point, then the daily dose will be decreased to 70mg per day. If the blood dasatinib level is adequately low, then the participant will continue taking 100mg per day. This process will be repeated on days 28 and 56, with further lower dose levels of 50mg per day and 50mg every other day available if blood dasatinib levels are above the specific concentration. The dose level may also be dropped at any time if signs of drug toxicity are present. Participants may also be escalated back up a dose level (up to a maximum of 100mg per day), if further blood tests every 3-6 months show that the drug has not sufficiently decreased markers of the leukaemia, i.e. treatment has not been adequately effective. Participants will continue taking the drug for the two year study period, followed by a further three years if it has proven to be safe and effective in these patients. It is hoped that the findings of this study will provide information on whether an individualised dose of dasatinib can be used in elderly CML-CP patients to minimise toxicity whilst maintaining the therapeutic effect to treat the disease

Recruiting Hospitals Read MoreRead more

Olivia Newton-John Cancer Wellness & Research Centre
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

Border Medical Oncology
Albury
Ms Nyree Sarakis
Nsarkis@bordermedonc.com.au
02 6064 1493

Barwon Health, University Hospital Geelong
Geelong
Dr Lea-Anne Harrison
leaanne.harrison@barwonhealth.org.au
03 42 15 2758

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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