Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age15+
SponsorThe First Affiliated Hospital of Soochow University
About this trial
The purpose of this study is to evaluate the efficacy and safety of venetoclax combined with azacitidine regimen for newly diagnosed T-ALL patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged ≥ 15.
Patients diagnosed with T-ALL according to 2016 WHO criteria for precursor lymphoid neoplasms.
ECOG performance status score less than 3.
Patients without serious heart, lung, liver, or kidney dysfunction.
Disqualifiers
Patients who are allergic to the study drug or drugs with similar chemical structures.
Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
Patients with uncontrolled active infection
Patients with active bleeding.
Trial design
Design model
Single group
Treatments tested in this trial
Venetoclax, Azacitidine
DrugVenetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-21); azacitidine 75 mg/m2 subcutaneously once daily on days 1-7.
Treatment groups
28 Participants
are divided into 1 treatment groupGroup A: Venetclax combined with AzacitidineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall Response Rate (ORR)
The overall response (complete remission, complete remission with incomplete blood count recovery) rate achieved after one or two courses (21 days) induction therapy by venetoclax combined azacitidine regimen.
Time frame
At the end of Cycle 1 (each cycle is 21 days)Secondary outcomes
1
Overall survial (OS)
It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.
Time frame
2 years2
Progression-Free Survival (PFS)
It is measured from the date of entry into this trial to the date of progression or death.
Time frame
2 years3
Number of adverse events
Adverse events are evaluated with CTCAE V5.0.
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
The First Affiliated Hospital of Soochow University
Lead sponsor
Jining Medical University
Collaborator
The Second People's Hospital of Huai'an
Collaborator
The First Affiliated Hospital of Bengbu Medical University
Collaborator
Northern Jiangsu People's Hospital
Collaborator
Affiliated Hospital of Nantong University
Collaborator
Suzhou Hospital of Traditional Chinese Medicine
Collaborator
Source ClinicalTrials.gov