Realgar indigo formula plus retinoic acid as postremission treatment for high-risk acute promyelocytic leukemia patients: a multicenter, single-arm, phase II study

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900023309

Enrollment

Unknown

Registered

2019-05-21

Start date

2019-06-01

Completion date

Unknown

Last updated

2019-05-27

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

Conditions

Acute Premyelocytic Leukemia

Interventions

Case series:Realgar indigo formula plus retinoic acid

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) The newly diagnosed acute promyelocytic leukemia patients (according to the 2016 revision to the World Health Organization (WHO) classification of myeloid neoplasms and acute leukemia); 2) WBC>10×10^9/L at the time of initial diagnosis; 3) Complete treatment after induction therapy; 4) Aged = 16 years old; 5) Liver function: ALT and AST = 2.5 times normal high limit, bilirubin = 2 times normal high limit; 6) Renal function: creatinine = 3 times normal high limit; 7) Signed informed consent.

Exclusion criteria

Exclusion criteria: 1) can not oral RIF or ATRA; 2) Pregnancy.

Design outcomes

Primary

Measure	Time frame
EFS;	—

Secondary

Measure	Time frame
molecular remission;relapse;EFS;OS;Safety;quality of life;	—

Countries

China

Contacts

Public ContactJie Jin

The First Affiliated Hospital, College of Medicine, Zhejiang University

jiej0503@163.com+86 13505716779

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 13, 2026