Venetoclax in Combination With Azacitidine9 Aug. 2018
- SUB-TYPE OF MDS: All Intermediate 2 or High Risk patients who have never had treatment for MDS
- SEVERITY OF MDS: High risk
- NAME OF DRUG: Venetoclax (a drug that encourages the death of cancer cells by blocking a marker on the cells called BCL-2) plus Azacitidine.
- Aims and benefits: To determine the safety and effectiveness of Venetoclax in combination with Azacitidine compared with Azacitidine alone. This study is designed for patients who have never had treatment for higher risk MDS.
- Primary outcome measures:
- Overall response rate
- Recommended dose and dosing schedule of Venetoclax in combination with Azacitidine
- Percentage of patients with side effects
- Secondary outcome measures:
- Complete response rate
- Improved blood counts
- Reduced need for blood and platelet transfusions
- Reduction in bone marrow blasts
- Time to transformation to acute myeloid leukaemia
- Basic inclusion criteria:
- Diagnosis of de novo MDS (no identifiable cause for the MDS) with IPSS risk Intermediate-2 or high
- Between 5 and 30% blasts in the bone marrow
- ECOG performance status of 0, 1 or2
- Patient has not received previous treatment (excluding supportive care) for MDS
- Patient is not a candidate to undergo intensive chemotherapy or allogeneic hematopoietic stem cell transplantation (HSCT)
- Basic exclusion criteria:
- MDS related to previous medications
- MDS evolving from a pre-existing myeloproliferative neoplasm (MPN)
- Diagnosis of MDS/MPN overlap
- Patients who have received allogeneic HSCT or solid organ transplantation.
- Trial sites/locations and name of physician in charge of trial:
- More information:
Please read information and always discuss trial information with your own physician.