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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

The main objective of the study is to evaluate the efficacy and safety of maintenance therapy with hypomethylating agent and Venetoclax to improve leukemia free survival for high-risk myeloid malignancies after allogeneic hematopoietic stem cell transplantation .

Eligibility criteria

Qualifiers

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;

Disqualifiers

Concurrent use of targeted drugs ;

Resistant to Venetoclax before transplantation;

Allergic to decitabine , Azacitidine or venetoclax;

Active grade II or higher acute GVHD ;

Trial design

Treatments tested in this trial

  • Venetoclax
  • Azacitidine or decitabine

Treatment groups

78 Participants
are divided into 1 treatment group