Last updated: February 19, 2023
Sponsor: First Affiliated Hospital of Zhejiang University
Overall Status: Active - Recruiting
Phase
2
Condition
Hematologic Neoplasms
Blood Cancer
Treatment
N/AClinical Study ID
NCT04809181
ZJU-HSCT-AZA02
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 achievedcomplete remission.
- MRD was positive after transplantation, MFC > 0.1% and / or fusion gene and genemutation (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 theend 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 researchprocedure and can sign the informed consent in writing.
Exclusion
Exclusion Criteria:
- Patients with severe cardiac insufficiency and EF lower than 60%; or patients withsevere 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 orvenetoclax.
- In patients with severe pulmonary insufficiency (obstructive and / or restrictiveventilation disorders), the researchers evaluated the patients who could not toleratethe 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 morethan 2 times of the upper limit of the normal value (ULN), or the 24-hour creatinineclearance rate (CR) is less than 50ml / min, the researchers evaluated that they couldnot tolerate the super pretreatment scheme.
- In patients with severe active infection, the researchers evaluated that they couldnot tolerate the pretreatment.
- Patients who had allergic reactions or serious adverse reactions in the previous useof pretreatment related drugs could not be included in the study.
- Patients with hematological recurrence (bone marrow smear: proportion of primordialcells >=5%) or any extramedullary recurrence.
- Other reasons why the researchers could not be selected.
Study Design
Total Participants: 95
Study Start date:
March 19, 2021
Estimated Completion Date:
March 19, 2026
Study Description
Connect with a study center
The first Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang 310000
ChinaActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.