Oral etoposide combined with realgar natural indigo tablets and all-trans retinoic acid in the treatment of high-risk acute promyelocytic leukemia

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2100005369

Enrollment

Unknown

Registered

2021-12-02

Start date

2022-01-01

Completion date

Unknown

Last updated

2023-02-20

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

Conditions

high-risk acute promyelocytic leukemia

Interventions

Oral etoposide group:Oral etoposide

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1)Newly diagnosed high-risk APL(WHO classification 2016);2) Age from 18-70(18 and 70 are included);3) Without uncontrolled active infection;4) Without organ failure;5) Liver function:serum ALT and AST=2.5*ULN,serum bilirubin=2.0*ULN;6) Kidney function:serum Cr=3.0*ULN

Exclusion criteria

Exclusion criteria: 1) With cerebral hemorrhage; 2) Gestation;3) Suffering from mental illness or other conditions that cannot be carried out according to the scheme;4) Unable to take oral drugs;5) Uncontrolled active infection;6) Organ failure; 7) Allergic to etoposide.

Design outcomes

Primary

Measure	Time frame
remission rate;death rate;	—

Secondary

Measure	Time frame
Overall survival rate;safety;Event free survival rate;cumulative recurrence rate(1year \2year));	—

Countries

China

Contacts

Public ContactHao Jiang

2516735116@qq.com13601164350

Outcome results

None listed

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