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A Phase II Study to Assess All-trans Retinoic Acid and Tetra-arsenic Tetra-sulphide Formula with Venetoclax for the Treatment of Acute Promyelocytic Leukemia

A Phase II Study to Assess All-trans Retinoic Acid and Tetra-arsenic Tetra-sulphide Formula with Venetoclax for the Treatment of Acute Promyelocytic Leukemia

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066592
Enrollment
Unknown
Registered
2022-12-09
Start date
2022-12-12
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Acute Promyelocytic Leukemia

Interventions

Test group:ATRA plus RIF and Venetoclax

Sponsors

First Affiliated Hospital of Xian Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 16-80 years ; 2.Confirmed as APL with t ( 15 ; 17 ) ( q22 ; q12 ) and newly diagnosed patients with PML-RARa ( detected by cytogenetics or RT-PCR ) ;

Exclusion criteria

Exclusion criteria: 1. Patients with severe liver function or renal insufficiency ( serum creatinine > 2.5 times the upper limit of normal serum total bilirubin = 2 times the upper limit of normal ALT and AST > 3 times the upper limit of normal that was not related to APL) or cardiac insufficiency ( EF480ms excluding electrolyte disturbances ) 2.Combined with other malignant tumors 3.Pregnant and lactating women

Design outcomes

Primary

MeasureTime frame
Complete molecular remission rate;Cumulative incidence of relapse;

Secondary

MeasureTime frame
Time to complete remission;Early death rate;2 year event-free survival ;

Countries

China

Contacts

Public ContactHuaiyu Wang

First Affiliated Hospital of Xian Jiaotong University

whymed@126.com+86 18991232410

Outcome results

None listed

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