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A prospective multicenter randomized controlled clinical study on reducing complications of induction therapy for acute promyelocytic leukemia in children

A prospective multicenter randomized controlled clinical study on reducing complications of induction therapy for acute promyelocytic leukemia in children

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038877
Enrollment
Unknown
Registered
2020-10-08
Start date
2020-10-09
Completion date
Unknown
Last updated
2021-01-05

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

Conditions

Acute promyelocytic leukemia in children

Interventions

Control group:Induction therapy
Experimental group:Induction therapy+idarubicin

Sponsors

The First Affiliated Hospital of Sun Yat sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 16 Years

Inclusion criteria

Inclusion criteria: 1. Patients under 16 years old; 2. Patients with PML-RAR a / T (15; 17) positive acute promyelocytic leukemia (APL); 3. Newly diagnosed patients.

Exclusion criteria

Exclusion criteria: 1. Patients with intracranial hemorrhage and one of the following manifestations: coma, convulsion, hemiplegia, cranial nerve paralysis. 2. Patients with CNSL and one of the following manifestations before enrollment: coma, convulsion, hemiplegia, cranial nerve paralysis. 3. Patients whose QTc of ECG is not more than 500ms cannot use RIF normally.

Design outcomes

Primary

MeasureTime frame
Coagulation function;Cardiac function;basic value of Urine arsenic;Routine examination before treatment of leukemia;Relief rate;five year event-free survival rate;ten year event-free survival rate;Overall survival rate;Arsenic excretion and residue;Cumulative hospitalization time;Cost of treatment;MRD;hyperleukocytosis;introduction differentiation syndrome;

Countries

China

Contacts

Public ContactYanlai Tang

The First Affiliated Hospital of Sun Yat-Sen University

tangyanlai@126.com+86 15626202579

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026