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China Children's Leukemia Group(CCLG) - APL 2021 supplementary study of Venetoclax in APL reduction therapy

China Children's Leukemia Group(CCLG) - APL 2021 supplementary study of Venetoclax in APL reduction therapy - Venetoclax in APL reduction therapy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069288
Enrollment
Unknown
Registered
2023-03-12
Start date
2023-03-10
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Acute promyelocytic leukemia (APL)

Interventions

Experimental group:Venetoclax

Sponsors

Beijing Children's Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. Meeting the diagnostic criteria: positive PML-RARa and/or having t(15; 17)(q22; q21) chromosome translocation. 2. Aged 5.0x10^9/L before treatment. 4. Patients with leukocyte 5.0x10^9/L after induction differentiation treatment. 5. Obtain a signed informed consent form from the patient or family member.

Exclusion criteria

Exclusion criteria: 1. Allergy to Venecra, tretinoin or arsenic involved in this program. 2. Any comorbidities or mental illnesses with significant abnormalities that affect patient life safety and compliance, informed consent, study participation, follow-up, or interpretation of results. 3. Participate in other clinical researchers at the same time.

Design outcomes

Primary

MeasureTime frame
Early mortality;Incidence of complications;Infusion of blood products;Induction therapy D28 for bone marrow remission status and MRD assessment;

Secondary

MeasureTime frame
1-year overall survival rate;1-year event-free survival rate;

Countries

China

Contacts

Public ContactZheng Huyong

Beijing Children's Hospital, Capital Medical University

zhenghuyong@vip.sina.com+86 10 5961 7621

Outcome results

None listed

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