Advancing treatment therapies in Myelodysplasia

Phase 1

Recruiting

• Conditions: Myelodysplasia; Cancer - Leukaemia - Acute leukaemia

• Registration Number: ACTRN12622000410752
• Lead Sponsor: Australasian Leukaemia and Lymphoma Group (ALLG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-10
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1.Provision of written informed consent
2.Provision of written informed consent to the ALLG NBCR
3.Age 18+ (Age 16-17 permitted if consent for minor PICF approved by the authorising HREC)
4. A diagnosis of MDS or AML with less than 30% blasts

Exclusion Criteria

1.History of other malignancy requiring active systemic treatment, or which is likely to result in an expected survival time of less than 12 months.
2.Viral infection with known HIV or viral hepatitis type B or C not adequately controlled by antiviral medication
3.Prior bone marrow or stem cell transplantation for a diagnosis of Myelodysplasia or acute myeloid leukaemia. If stem cell transplantation has been undertaken for other reasons- refer to individual domain and discuss with study team.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event free survival will be assessed by analysing morphological blood and bone marrow markers of disease response eg white cell count and blast count. [. The endpoints are likely to be assessed for each treatment domain when all patients have completed the domain specific treatment period and trial follow up period. This could be 2-5 years depending on the trial domain. ];Overall response rate will be assessed by analysing morphological blood and bone marrow markers of disease response eg white cell counts and blast count. [ The endpoints are likely to be assessed for each treatment domain when all patients have completed the domain specific treatment period and trial follow up period. This could be 2-5 years depending on the trial domain. ]

Secondary Outcome Measures

Name	Time	Method
Overall survival will be assessed by reviewing patient medical records.[The endpoints are likely to be assessed for each treatment domain when all patients have completed the domain specific treatment period and trial follow up period. This could be 2-5 years depending on the trial domain. ];Transfusion independence will be assessed using blood count markers, eg whether a patient blood count infers a transfusion is required. [The endpoints are likely to be assessed for each treatment domain when all patients have completed the domain specific treatment period and trial follow up period. This could be 2-5 years depending on the trial domain. ];Quality of life using the EORTC QLQ 30 questionnaire will be completed by the enrolled patients. [Questionnaires will be completed at baseline, 6, 12, 18, and 24 months of treatment with results analysed at the end of the treatment period. ]