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A Randomized Phase III Study to Compare Oral Tetra-arsenic Tetra-sulphide Formula Plus ATRA Versus Intravenous Arsenic Trioxide Plus ATRA for Newly Diagnosed, Non High-Risk Acute Promyelocytic Leukemia

A Randomized Phase 3 Study to Compare Oral Tetra-arsenic Tetra-sulphide Formula Plus ATRA Versus Intravenous Arsenic Trioxide Plus ATRA for Newly Diagnosed, Non High-Risk Acute Promyelocytic Leukemia

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13004054
Enrollment
Unknown
Registered
2013-12-27
Start date
2014-02-13
Completion date
Unknown
Last updated
2018-01-22

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

Conditions

Acute Promyelocytic Leukemia

Interventions

study group:Oral Tetra-arsenic Tetra-sulphide Formula Plus ATR
control group:EFS

Sponsors

Peking University People's Hospital Address
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed APL by cytomorphology, confirmed also by molecular analysis; 2. To be aged 18 to 71 years; 3. WHO performance status 0-2 included;4.white blood cell at diagnosis <=10*10^9/L; 5. Serum total bilirubin <=3.0 mg/dL (<=51umol/L); 6. Serum creatinine <=3.0 mg/dL (<=260 umol/L); 7.Signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. cerebral ischemic; 2. pregnancy; 3. Subjects who cannot sign written informed consent; 4. Significant arrhythmias, EKG abnormalities or neuropathy; 5. Subjects who cannot comply with the study.

Design outcomes

Primary

MeasureTime frame
Rate of Event-free survival (EFS);Rate of cumulative incidence of relaps;Rate of cumulative incidence of relapse;

Secondary

MeasureTime frame
Rate of hematological complete remission;Overall survival rate;Incidence of hematological and non-hematological toxicity episodes during treatment as assessed by National Cancer Institute Common Toxicity Criteria;Quality of life at the end of induction therapy and at the end of the consolidation course;

Countries

China

Contacts

Public ContactXiao-Jun Huang

Peking University People's Hospital

xjhrm@medmail.com.cn+86 13701389625

Outcome results

None listed

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