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

NCT ID: NCT05841771

Condition: Hypomethylating Agent
Venetoclax
Myeloid Malignancy

Conditions: Official terms:
Neoplasms
Azacitidine
Decitabine
Venetoclax

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Venetoclax
Description: 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.
Arm group label: AZA-VEN maintenance

Other name: BCL-2 inhibitor

Intervention type: Drug
Intervention name: Azacitidine or decitabine
Description: azacytidine 32mg/m2 or decitabine 5mg/m2
Arm group label: AZA-VEN maintenance

Other name: Hypomethylating Agent

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 .

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Shanghai Jiao Tong University School of Medicine Affilated Shanghai General Hospital

Address:
City: Shanghai
Zip: 200080
Country: China

Status: Recruiting

Contact:
Last name: Xueying Ding, Ph.D

Phone: 86-21-36126060
Email: shiyicss@126.com

Contact backup:
Last name: Yanhong Zhu, M.S

Phone: 86-21-63240090

Phone ext: 6213
Email: sfph_edu2@163.com

Investigator:
Last name: Liping Wan, M.D., Ph.D.
Email: Principal Investigator

Start date: January 1, 2023

Completion date: December 31, 2025

Lead sponsor:
Agency: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Agency class: Other

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

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05841771

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