NCT05361057

Efficacy of Venetoclax Based Regimen in Prevention Relapse of Consecutive MRD Positive AML Patients

Terminated Phase 2 Last updated 5 December 2025

What this trial tests

Phase 2 trial testing Venetoclax, Azacitidine in Acute Myeloid Leukemia in 20 participants. Terminated before completion.

Timeline

29 June 2022

Primary endpoint
28 February 2023

23 January 2024

Quick facts

Lead sponsor	Institute of Hematology & Blood Diseases Hospital, China
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	29 June 2022
Primary completion	28 February 2023
Estimated completion	23 January 2024
Sites	1 location across China

Drugs / interventions tested

• Venetoclax, Azacitidine
• Venetoclax, daunorubicin, cytarabine — full drug profile →

Conditions studied

• Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
• Measurable Disease — all drugs for Measurable Disease →

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Who can join

18 and older, any sex, with Acute Myeloid Leukemia or Measurable Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Measurable disease (MRD) plays an important role in the therapeutic efficacy and prognosis of acute myeloid leukemia (AML). Studies show that persistent MRD positivity after induction indicates that the patient has a higher risk of recurrence. Even if the patient is assessed as a low risk group, once there is persistent MRD positive, Allogeneic hematopoietic stem cell transplantation (allo HSCT) or clinical trials should be considered to improve the overall survival of patients. However, some patients cannot accept allo HSCT due to economic reasons or lack of suitable donors. How to prolong the recurrence free survival of these patients is still a great challenge. Platzbecker et al. applied azacytidine (AZA) monotherapy to AML patients with continuous MRD positive after combined chemotherapy. The results showed that the preemptive treatment of AZA could prevent or significantly delay the hematological relapse of MDS or AML patients with MRD positive. In addition, the application of venetoclax has significantly changed the therapeutic prospect of AML and provided new opportunities. Studies have shown that venetoclax can enhance the activity of anti HMA, cytarabine, idarubicin and other drugs. The curative effect of venetoclax combined with AZA in the treatment of elderly AML patients who are not suitable for intensive treatment is better than that of single AZA regimen, and the negative rate of MRD after induction treatment of venetoclax combined with HMA is higher (54-81%). Therefore, the investigators believe that for patients who continue to be MRD positive after induction and consolidation treatment, venetoclax based regimen may be an effective preemptive treatment regimen, which can prolong the relapse free time and overall survival of these patients

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Crosstalk between metabolic reprogramming and epigenetics in cancer: updates on mechanisms and therapeutic opportunities.
   Ge T, Gu X, Jia R, Ge S, et al · · 2022 · cited 129× · PMID 36266736 · DOI 10.1002/cac2.12374