Hypomethylating Agent and Venetoclax After Allo-HSCT in Patients With High-risk Myeloid Malignancies.

Launched by SHANGHAI GENERAL HOSPITAL, SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · May 2, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with high-risk myeloid malignancies, such as acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS), who have already undergone a stem cell transplant. The goal is to see if using a combination of medications called a hypomethylating agent and Venetoclax as maintenance therapy can help these patients stay leukemia-free for a longer time after their transplant.

To participate in this study, patients need to be between the ages of 65 and 75 and must have received a stem cell transplant for their condition, along with some specific high-risk factors. These may include certain genetic features or a history of needing multiple treatments to achieve remission. Participants will be closely monitored for the safety and effectiveness of the treatment. It's important to note that individuals with certain health issues or complications may not be eligible for this trial. Overall, this study aims to offer hope and potentially improve outcomes for patients facing challenging blood cancers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with AML or MDS and have received allogeneic hematopoietic cell transplantation;
• • Patients with AML must have one of the following high-risk factors: Cytogenetics and molecular features consistent with adverse risk group by European LeukemiaNet classification for AML； require more than 2 courses of induction chemotherapy to reach complete remission； Extramedullary myeloid malignancy；≥CR2； Presence of measurable residual disease at the time of HSCT. \*
• • Patients with MDS must have one of the following high-risk factors: IPSS-R scores are high-risk or very high-risk； Presence of TP53 mutation； Presence of measurable residual disease at the time of HSCT. \*
• • CBC: ANC ≥ 1.0 × 10e9/L, Hb ≥ 80g/L, and PLT ≥ 50 × 10e9/L；
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• • Presence of measurable residual disease at the time of HSCT is defined as the following: Blast percentage in bone marrow detected by flow cytometry ≥0.01%； Presence of fusion gene or mutated gene by qPCR.
• Exclusion Criteria:
• • Concurrent use of targeted drugs ;
• • Resistant to Venetoclax before transplantation;
• • Allergic to decitabine , Azacitidine or venetoclax;
• • Active grade II or higher acute GVHD ;
• • Active moderate or severe chronic GVHD ;
• * Diseases recurrence (abnormal myeloid cells detected by flow cytometry \>0.01%, presence of WT1 or other genes, or extramedullary malignancy ), percentage of donor cells in bone marrow \<90% or graft rejection:
• • CBC: ANC \< 1.0 × 10e9/L, or PLT \< 50 × 10e9/L；
• • Severe organ dysfunction: Elevated Aspartate transaminase (AST) /alanine transaminase (ALT), or direct bilirubin \>3 times upper limit of normal; Creatinine clearance (Ccr)\<50mL/min or serum creatinine \>1.5 times upper limit of normal, whether hemodialysis treatment is performed;
• • Active uncontrolled systemic fungal, bacterial, or viral infection
• • Pregnant or lactating women;
• • Other severe complications and not suitable judged by researchers.