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Comparison of efficacy between Oral Realgar-Indigo naturalis formula (As4S4) and intravenous arsenic trioxide (As2O3) in treatment of newly diagnosed acute promyelocytic leukemia patients-A prospective randomized controlled trial

Comparison of efficacy between Oral Realgar-Indigo naturalis formula (As4S4) and intravenous arsenic trioxide (As2O3) 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-12002151
Enrollment
Unknown
Registered
2012-05-07
Start date
2007-11-01
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

A:As4S4 60mg/kg.d. orally taken once daily until completer remission
B:As2O3, arsenic trioxide 0.16mg/kg.d,Intravenous drop infusion until complete remission

Sponsors

Peking University People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed acute promyelocytic leukemia patients; 2. Age 14-60 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. age below 15 years or over 60 years.

Design outcomes

Primary

MeasureTime frame
complete remission;disease free survival (DFS);mean overall survival (OS);—

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