NCT05376111

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of venetoclax combined with azacitidine regimen for newly diagnosed T-ALL patients.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
7mo left

Started Apr 2022

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Apr 2022Dec 2026

Study Start

First participant enrolled

April 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 11, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 17, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

4.7 years

First QC Date

May 11, 2022

Last Update Submit

March 17, 2026

Conditions

T-cell Acute Lymphoblastic LeukemiaRecruiting

Keywords

VenetoclaxAzacitidineT-ALLNewly diagnosed

Outcome Measures

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.

    At the end of Cycle 1 (each cycle is 21 days)

Secondary Outcomes (3)

  • Overall survial (OS)

    2 years

  • Progression-Free Survival (PFS)

    2 years

  • Number of adverse events

    2 years

Study Arms (1)

Venetclax combined with Azacitidine

EXPERIMENTAL

T-cell acute lymphoblastic leukemia patients reveive venetoclax combined with azacitidine regimen treatment.

Drug: Venetoclax, Azacitidine

Interventions

Venetoclax, AzacitidineDRUG

Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-21); azacitidine 75 mg/m2 subcutaneously once daily on days 1-7.

Venetclax combined with Azacitidine

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Ability to understand and voluntarily provide informed consent.

You may not qualify if:

  • 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.
  • Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.
  • Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met.
  • Liver dysfunction (total bilirubin \> 1.5 times the upper limit of the normal range, ALT/AST \> 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT/AST \> 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine \> 1.5 times the upper limit of the normal value).
  • Patients with a history of clinically significant QTc interval prolongation (male \> 450 ms; female \> 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment.
  • Surgery on the main organs within the past six weeks.
  • Drug abuse or long-term alcohol abuse that would affect the evaluation results.
  • Patients who have received chemotherapy treatments related to the disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

venetoclaxAzacitidine

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 11, 2022

First Posted

May 17, 2022

Study Start

April 1, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)