Safety of two dosage forms of mitoxantrone on cardiac stress in children with acute nonlymphocytic leukemia (non-M3): a randomized, controlled phase II clinical trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200063394

Enrollment

Unknown

Registered

2022-09-06

Start date

2022-09-01

Completion date

Unknown

Last updated

2023-04-17

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

Conditions

acute nonlymphocytic leukemia (non-M3)

Interventions

Group A:Treatment with mitoxantrone water

Group B: Treatment with mitoxantrone power

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Complete blood routine, bone marrow cell morphology, immunology and genetic examination, and meet the diagnostic criteria for acute non-lymphocytic leukemia; 2. The age before enrollment is less than or equal to 18 years old. 3. No serious heart, lung, liver or kidney disease before enrollment, no history of heart failure. 4. Not participating in other types of clinical trials within the past 3 months. 5. The family members signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. History of chemotherapy or radiotherapy in the past. 2. Bone marrow failure syndrome secondary to acute myeloid leukemia. 3. Down syndrome (DS) 4. Acute promyelocytic leukemia (APL, or M3) 5. Juvenile myelomonocytic leukemia (JMML) 6. Myelodysplastic Syndrome (MDS) 7. Positive pregnancy test for Fanconi anemia

Design outcomes

Primary

Measure	Time frame
heart failure;heart enlargement;myocardial damage;	—

Countries

China

Contacts

Public ContactJianpei Fang

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

jpfang2005@163.com+86 13682290830

Outcome results

None listed

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