Safety and efficacy of Chidamide combined with chemotherapy in the treatment of newly diagnosed T-cell acute lymphoblastic leukemia in children: a multicenter randomized controlled study.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300075225

Enrollment

Unknown

Registered

2023-08-30

Start date

2023-09-01

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood T-cell acute lymphoblastic leukemia

Interventions

T-ALL control group:Dexamethasone, vincristine, daunorubicin, asparaginase

T-ALL experimental group:Dexamethasone, Vincristine, Daunorubicin, Asparaginase, Cedaramine

Eligibility

Sex/Gender

All

Age

1 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1.The age at the time of signing informed consent = 1 and under the age of 18; 2. Patients diagnosed with T-cell acute lymphoblastic leukemia (T-ALL); 3. New onset patients; 4. Who will participate research and guardian to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.With acute mixed-phenotypic leukemia (see annex I of the researcher's manual for diagnostic criteria); 2. With secondary immunodeficiency; 3. Patients with leukemia which is the second tumor; 4. With definite CML abrupt change; 5.ALL with Down's syndrome; 6. Patients who used glucocorticoids for more than one week in the month before enrollment; 7. Patients who used anthracyclines within one month before enrollment. 8.Severe hepatic insufficiency(ALT or AST =3xULN). 9.Severe renal impairment (eGFR < 30 ml/min/1.73m3 or end-stage renal disease patients). 10.Heart disease, New York Heart Association (NYHA) classification of grade 3 or above heart failure, or severe arrhythmia requiring treatment, or recent myocardial infarction within 6 months after randomization. 11.Patients with a history of deep vein thrombosis or stroke within 24 weeks prior to enrollment. 12.Patients with a history of acute or chronic pancreatitis within 24 weeks prior to enrollment. 13.Any significant other medical condition, laboratory abnormality, or psychiatric illness that the investigators consider unsuitable for inclusion.

Design outcomes

Primary

Measure	Time frame
Event free survival;	—

Secondary

Measure	Time frame
Complete remission;Cumulative incidence rate;Overall survival;Minimal residual disease ;	—

Countries

China

Contacts

Public ContactJianpei Fang

Sun Yat-Sen Memorial Hosipital of Sun Yat-Sen University

jpfang2005@163.com+86 136 8229 0830

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026