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RECRUITING

NCT05841771

PHASE2

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

Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

Summary

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 .

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.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-01-01

Completion Date

2025-12-31

Last Updated

2024-08-09

Healthy Volunteers

Conditions

Hypomethylating Agent Venetoclax Myeloid Malignancy

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 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.

DRUG

Azacitidine or decitabine

azacytidine 32mg/m2 or decitabine 5mg/m2

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.

Locations (1)

Shanghai Jiao Tong University School of Medicine Affilated Shanghai General Hospital

Shanghai, Shanghai Municipality, China