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Recruiting NCT05841771

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

Phase II Interventional Hypomethylating Agent Venetoclax Myeloid Malignancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Venetoclax, Azacitidine or decitabine.
Who it may be relevant to
Registry conditions: Hypomethylating Agent, Venetoclax, Myeloid Malignancy. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Single Arm, Phase 2 Study Evaluating Safety and Efficacy of Maintenance Therapy With Hypomethylating Agent and Venetoclax After Allogeneic Stem Cell Transplantation in Patients With f High-risk Myeloid Malignancies.

Overview

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 .

Detailed description

This is a prospective single-arm study. Patients with high-risk AML or MDS aged between 18-70 years old will enroll in the study. They will be given hypomethylating agents (azacytidine 32mg/m2 or decitabine 5mg/m2) for 5 days and venetoclax 400mg/d for 7 days after allogeneic hematopoietic stem cell transplantation. The maintenance therapy will start from 60th days posttransplant, repeated every 28 days until up to 1-year posttransplant. The 1-year leukemia-free survival rate，1-year cumulative recurrence rate, and 1-year overall survival will be analyzed.

Interventions

  • Drug Venetoclax
    Participants will receive maintenance therapy with venetoclax and azacitidine or decitabine after allogeneic stem cell transplantation. Azacitidine will be administered once daily subcutaneously (32mg/m2/d) on days 1-5, and venetoclax will be administered once daily orally (400mg/day) on days 1-7. If the patient is refractory or allergic to azacitidine, they will receive decitabine. Decitabine will be administered intravenously (5mg/m2/d) on days 1-5. If the patient is treated with CYP450 inhib
  • Drug Azacitidine or decitabine
    azacytidine 32mg/m2 or decitabine 5mg/m2

Primary outcome measures

  • Leukemia-free survival (LFS) time [Time frame: From the date of transplantation, assessed up to 1 year after transplantation.]
Secondary outcome measures (3)
  • Cumulative incidence of relapse [Time frame: From the date of transplantation, assessed up to 1 year after transplantation.]
  • Overall survival [Time frame: From the date of transplantation, assessed up to 1 year after transplantation.]
  • Incidence of toxicity of the regimen [Time frame: From the date of transplantation, assessed up to 1 year after transplantation.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Jiao Tong University School of Medicine Affilated Shanghai General Hospital — Shanghai

Identifiers

NCT: NCT05841771 · SHSYXY-AZA-VEN-202301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗