Azacitidine in Combination With Venetoclax Treatment for Prevention of Relapse in MRD Positive Post Allogeneic Hematopoietic Stem Cell Transplantation Acute Myelogenous Leukemia/ Myelodysplastic Syndrome Patients

Who is this study for? Adult patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

In patients with MRD-positive patients after AML/MDS allogeneic hematopoietic stem cell transplantation, azacytidine combined with venetoclax may be effective in eliminating micro residual diseases, reducing the risk of relapse, and ultimately improving long-term survival.The primary purpose of this study was to explore an effective protocol to reduce the risk of relapse in patients with MRD positive after allogeneic hematopoietic stem cell transplantation for AML/MDS.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Patients between 18 years old and 65 years old.

• Patients with AML or MDS diagnosed according to WHO diagnostic criteria.

• Patients who received allogeneic hematopoietic stem cell transplantation and achieved complete remission.

• MRD was positive after transplantation, MFC \> 0.1% and / or fusion gene and gene mutation (WT1 \> 0.6%, AML1-ETO \> 0.4%, others \>1%).

• ECOG body status score 0-2.

• Patients with expected survival time \>=3 months.

• Good organ function level: ANC (neutrophil absolute value \>=1.0x10\^9/L; PLT \>=30x10\^9/L; HB \>=80g/L; Tibil \<=1.5 ULN; ALT / AST \<=2.5 ULN; bun / Cr \<=1.5 ULN; LVEF \>=50%).

• Patients who have received any anti-tumor treatment (including radiotherapy, chemotherapy, surgery or molecular targeted treatment) for more than 4 weeks from the end of the previous treatment.

• Patients with no GVHD and no previous history of 3 or more degrees of aGVHD. 10. Patients who voluntarily participate in the clinical trial, understand the research procedure and can sign the informed consent in writing.

Locations
Other Locations
China
The first Affiliated Hospital of Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
Yi Luo, M.D.
luoyijr@163.com
+86057187233801
Backup
Yibo Wu, M.D.
wuyibo7@126.com
+8619858876273
Time Frame
Start Date: 2021-03-19
Estimated Completion Date: 2026-03-19
Participants
Target number of participants: 95
Treatments
Experimental: MRD positive AML/MDS patients after allogeneic hematopoietic stem cell transplantation
MRD positive AML/MDS patients after allogeneic hematopoietic stem cell transplantation
Sponsors
Collaborators: The First Affiliated Hospital of Zhejiang Chinese Medical University, Second Affiliated Hospital, School of Medicine, Zhejiang University, Jinhua Central Hospital, Taizhou Hospital, Yinzhou Hospital Affiliated to Medical School of Ningbo University, First Affiliated Hospital of Wenzhou Medical University, Union hospital of Fujian Medical University, Ningbo No. 1 Hospital, Sir Run Run Shaw Hospital, Xiangya Hospital of Central South University, Zhejiang Provincial People's Hospital
Leads: First Affiliated Hospital of Zhejiang University

This content was sourced from clinicaltrials.gov