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

ConditionsHypomethylating AgentVenetoclaxMyeloid Malignancy
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Venetoclax

    Drug

    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 inhibitors(such as posaconazole or voriconazole), the dose of venetoclax will reduce to 100 mg once daily on days 1-7. Maintenance therapy will start from the 60th to 120th days after allogeneic hematopoietic stem cell transplantation and repeat every 28 days for up to 10 cycles within the first year after transplantation.

  • Azacitidine or decitabine

    Drug

    azacytidine 32mg/m2 or decitabine 5mg/m2

Treatment groups

78 Participants
are divided into 1 treatment group
Group A: AZA-VEN maintenanceExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Leukemia-free survival (LFS) time

Summary statistics for LFS time will be computed for all patients.

Time frame
From the date of transplantation, assessed up to 1 year after transplantation.

Secondary outcomes

1

Cumulative incidence of relapse

Use the method of Gooley et al to estimate the cumulative incidence of relapse.

Time frame
From the date of transplantation, assessed up to 1 year after transplantation.
2

Overall survival

The method of Kaplan and Meier will be used to estimate the distribution of overall survival. Cox proportional hazards regression analysis will be used to model the association between overall survival and covariates of interest.

Time frame
From the date of transplantation, assessed up to 1 year after transplantation.
3

Incidence of toxicity of the regimen

Descriptive statistics will be used to summarize adverse events.

Time frame
From the date of transplantation, assessed up to 1 year after transplantation.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Lead sponsor

Source ClinicalTrials.gov
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