Single-arm, open, multicenter clinical study of Cladribine combined with HAG regimen in the treatment of relapsed/refractory pediatric acute myeloid leukemia

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000038340

Enrollment

Unknown

Registered

2020-09-19

Start date

2020-09-11

Completion date

Unknown

Last updated

2020-12-14

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

Conditions

Relapsed/refractory pediatric acute myeloid leukemia

Interventions

CHAG:Cladribine combined with HAG regimen

Eligibility

Sex/Gender

All

Age

No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. Aged <18 years; 2. Patients with acute myeloid leukemia who have not achieved complete remission after 2 courses of standard dose induction therapy, or relapse after CR. 3. Understand the study procedure and sign written informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Acute promyelocytic leukemia, Down syndrome associated acute myeloid leukemia, or mixed-phenotype acute leukemia; 2. The second tumor, or blastic-phase chronic myeloid leukemia; 3. Secondary to immunodeficiency.

Design outcomes

Primary

Measure	Time frame
Complete response (CR+CRi) rate after 1 course of CHAG treatment;	—

Secondary

Measure	Time frame
MRD after 1 course of CHAG treatment;Complete response (CR+CRi) rate after 2 courses of CHAG treatment;MRD after 2 courses of CHAG treatment;Overall survival;Event-free survival;	—

Countries

China

Contacts

Public ContactZhu Xiaofan

Institute of Hematology, Blood Disease Hospital, Chinese Academy of Medical Sciences

xfzhu@ihcams.ac.cn+86 13752090418

Outcome results

None listed

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