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China Children's Leukemia Group (CCLG)-AML2019 supplementary study on pediatric acute myeloid leukemia-Gilteritinib therapy

China Children's Leukemia Group (CCLG)-AML2019 supplementary study on pediatric acute myeloid leukemia-Gilteritinib therapy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062867
Enrollment
Unknown
Registered
2022-08-22
Start date
2022-08-22
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

pediatric acute myeloid leukemia

Interventions

Tolerant to chemotherapy group:Gilteritinib
Intolerant to chemotherapy group:Gilteritinib
Refractory or relapse group:Gilteritinib

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. Patients enrolled in China Children's Leukemia Group (CCLG)-AML2019 study; 2. Patients who do not remit from induction therapy, or who have persistently positive MRD after treatment, or whose MRD turn negative and then turn positive again or who have morphological relapse; 3. Patients with FLT3-mutated.

Exclusion criteria

Exclusion criteria: 1. Acute Promyelocytic Leukemia; 2. Junior Myelomonocytic Leukemia; 3. AML secondary to Fanconi Anemia; 4. AML secondary to Kostmann Syndrome; 5. AML secondary to Shwachman Syndrome; 6. AML secondary to other Bone Marrow Failure; 7. Patients who fail to receive systematic chemotherapy according to the protocol; 8. Patients who received any anti-tumor treatment within 2 weeks, except for those who received single IT injection or Hydroxycarbamide or low-dose Ara-c for Leukocytosis and have recovered from the adverse drug reactions; 9. Patients complicated with psychiatric disease or any other diseases that could affect their safety and compliance, participation, follow-up or interpretation of results.

Design outcomes

Primary

MeasureTime frame
Remission State of Bone Marrow;Minimal Residual Disease;Side effect of chemotherapy;

Countries

China

Contacts

Public ContactHuyong Zheng

Beijing Children's Hospital, Capital Medical University

zhenghuyong@bch.com.cn+86 10 59617621

Outcome results

None listed

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