Status:
RECRUITING
Azacitidine in Combination With Venetoclax Treatment for MRD Positive Post Allo-HSCT AML/MDS Patients
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Collaborating Sponsors:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Zhejiang Provincial People's Hospital
Conditions:
Hematologic Malignancy
Stem Cell Transplant Complications
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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, r...
Detailed Description
The technology of Allogeneic Hematopoietic stem cell transplantation (allo-HSCT) has been continuously improved, relpase is still the leading cause of death after allo-HSCT. Monitoring of micro residu...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patients with severe cardiac insufficiency and EF lower than 60%; or patients with severe arrhythmia who could not tolerate super pretreatment.
- Patients with activity of aGVHD or extensive cGVHD.
- Patients with BCR/ABL positive.
- Patients who were previously known to be resistant to azacytidine or dessicabine or venetoclax.
- In patients with severe pulmonary insufficiency (obstructive and / or restrictive ventilation disorders), the researchers evaluated the patients who could not tolerate the super pretreatment scheme.
- Patients with severe liver function impairment and liver function indexes (alt, TBIL) more than 3 ULN were evaluated as intolerant of super pretreatment.
- In patients with severe renal insufficiency, the renal function index (CR) is more than 2 times of the upper limit of the normal value (ULN), or the 24-hour creatinine clearance rate (CR) is less than 50ml / min, the researchers evaluated that they could not tolerate the super pretreatment scheme.
- In patients with severe active infection, the researchers evaluated that they could not tolerate the pretreatment.
- Patients who had allergic reactions or serious adverse reactions in the previous use of pretreatment related drugs could not be included in the study.
- Patients with hematological recurrence (bone marrow smear: proportion of primordial cells \>=5%) or any extramedullary recurrence.
- Other reasons why the researchers could not be selected.
Key Trial Info
Start Date :
March 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 19 2026
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT04809181
Start Date
March 19 2021
End Date
March 19 2026
Last Update
February 21 2023
Active Locations (1)
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1
The first Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310000