Azacitidine in Combination With Venetoclax Treatment for MRD Positive Post Allo-HSCT AML/MDS Patients

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/A

Clinical Study ID

NCT04809181
ZJU-HSCT-AZA02
  • Ages 18-65
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Patients between 18 years old and 65 years old.
  2. Patients with AML or MDS diagnosed according to WHO diagnostic criteria.
  3. Patients who received allogeneic hematopoietic stem cell transplantation and achievedcomplete remission.
  4. MRD was positive after transplantation, MFC > 0.1% and / or fusion gene and genemutation (WT1 > 0.6%, AML1-ETO > 0.4%, others >1%).
  5. ECOG body status score 0-2.
  6. Patients with expected survival time >=3 months.
  7. 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%).
  8. 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.
  9. 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:

  1. Patients with severe cardiac insufficiency and EF lower than 60%; or patients withsevere arrhythmia who could not tolerate super pretreatment.
  2. Patients with activity of aGVHD or extensive cGVHD.
  3. Patients with BCR/ABL positive.
  4. Patients who were previously known to be resistant to azacytidine or dessicabine orvenetoclax.
  5. In patients with severe pulmonary insufficiency (obstructive and / or restrictiveventilation disorders), the researchers evaluated the patients who could not toleratethe super pretreatment scheme.
  6. Patients with severe liver function impairment and liver function indexes (alt, TBIL)more than 3 ULN were evaluated as intolerant of super pretreatment.
  7. 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.
  8. In patients with severe active infection, the researchers evaluated that they couldnot tolerate the pretreatment.
  9. Patients who had allergic reactions or serious adverse reactions in the previous useof pretreatment related drugs could not be included in the study.
  10. Patients with hematological recurrence (bone marrow smear: proportion of primordialcells >=5%) or any extramedullary recurrence.
  11. 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

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 residual disease (MRD) after allogeneic HSCT provides a risk stratification of relpase risk in patients after transplantation.There is an urgent need to find an effective intervention plan for patients with MRD positive after transplantation, in order to reduce the risk of relapse after transplantation and improve long-term survival.The combination of demethylated drugs with venetoclax has shown promising results in clinical trials in AML patients who cannot tolerate induction chemotherapy.In patients with MRD-positive patients after AML/MDS allo-HSCT, azacytidine combined with venetoclax may be effective in eliminating small 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 allo-HSCT for AML/MDS.

Connect with a study center

  • The first Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

Map preview placeholder

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.