Comparison of As2O3 and As4S4 in treatment of newly diagnosed acute promyelocytic leukemia patients-A prospective randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-09000537

Enrollment

Unknown

Registered

2009-09-28

Start date

2009-09-08

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Acute promyelocytic leukemia

Interventions

Group A:As2O3, arsenic trioxide 0.16mg/kg.d, Intravenous drop infusion until complete remission

Group B:As4S4 60mg/kg.d. orally taken once daily until completer remission

Eligibility

Sex/Gender

All

Age

14 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed acute promyelocytic leukemia patients; 2. Age 14-70 years old; 3. Ogran function: serum bilirubinbi <=35umol/L, AST/ALT <=2 fold increase, Cr<=150umol/L; 4. Normal heartfunction; 5. Physical score 0~2(WHO); 6. Sign the informed consent document.

Exclusion criteria

Exclusion criteria: 1. Non-newly diagnosed acute promyelocytic leukemia patients; 2. WBC>=50*10^9/L before treatmetallergy to arsenics; 3. Renal or liver malfunction; 4. Uncontrolled heart failure/infection; 5. ECG:Q-T interval over 450ms; 6. Patients who have previous cancer treatments; 7. Previous diagnosis of hematology malignancy.

Design outcomes

Primary

Measure	Time frame
disease free survival (DFS);mean overall survival (OS);	—

Secondary

Measure	Time frame
safety;complete response (CR);	—

Countries

China

Contacts

Public ContactXiaojun Huang

xjhrm@medmail.com.cn+86 010 88325977

Outcome results

None listed

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