MDS05/D2 - Phase Ib/II study for treatment of Myelodysplasia (MDS) with SRA515 and ASTX727,
- Conditions
- Myelodysplastic Syndrome (MDS)Acute Myeloid Leukaemia (AML)Cancer - Leukaemia - Acute leukaemia
- Registration Number
- ACTRN12622001302741
- Lead Sponsor
- Australasian Leukaemia and Lymphoma Group (ALLG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 86
1. Provision of written informed consent
2. Provision of written informed consent to the Australasian Leukaemia and Lymphoma Group National Blood Cancer Registry (ALLG NBCR)
3. Age 18 and above (Age 16-17 permitted if consent for minor PICF approved by the authorising HREC)
4. A diagnosis of MDS or Acute Mueloid Leukaemia (AML) with less than 30% blasts
5. Treatment naïve myelodysplasia patients with IPSS score equal to 1.5 and be eligible for standard HMA treatment in Australia.
6. AML with blasts less than 30% will also be eligible for this domain of the study.
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 allogeneic bone marrow, HSCT or solid organ transplantation
4. Subjects with QTcF greater than 480msecs, confirmed by repeat ECG
5. Left Ventricular Ejection Fraction (LVEF) of less than 50%
6. Use of parenteral anticoagulants at therapeutic levels, warfarin or direct oral anticoagulants within 7 days prior to the first dose of SRA515
7.Coagulation parameters (prothrombin time/international normalised ratio [PT/INR] and activated partial thromboplastin time [APTT] of greater than or equal to 1.5 x the upper limit of normal (ULN)
8.Subjects with active bleeding and/or clinically significant bleeding in the last 12 months.
9.Subject has a history of an active malignancy within the past 2 years prior to study
entry, with the exception of:
a.Adequately treated in situ carcinoma of the cervix uteri
b.Adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin
c. Asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy
10.Subject has a known positive test for human immunodeficiency virus (HIV). Note: HIV testing is not required at Screening.
11.Subject has chronic active hepatitis B (HBV) or hepatitis C (HCV) requiring treatment.
12.Subject exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to ongoing systemic infection (viral, bacterial, or fungal). Note: Does not apply to Cohort 1 or Safety Expansion Cohort.
13.Subject has a malabsorption syndrome or other condition that precludes an enteral route of administration.
14.Subject has history of a significant cardiovascular (e.g. LVEF less than 50%), endocrine, hepatic, immunologic metabolic, neurologic, psychiatric, pulmonary, renal disease, or any other condition that in the opinion of the investigator would adversely affect his/her participation in this study or interpretation of study results. Note: For subjects who have required an intervention for any above diseases within the past 6 months needs a discussion between the investigator and study team.
15.Subject is concurrently participating in another therapeutic clinical trial.
16.Subject is pregnant or breastfeeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method