The multicenter, randomized parallel controlled, open clinical trial for G-CSF combine with low-dose dicitabine in the prophylaxis of high risk acute myeloid leukemia relapse after allogenetic hematopoietic stem cell transplantation

The clinical trial of G-CSF combine with low-dose dicitabine in the prophylaxis of high risk acute myeloid leukemia relapse after allogenetic hematopoietic stem cell transplantation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IIR-16008182

Enrollment

Unknown

Registered

2016-03-29

Start date

2016-04-01

Completion date

Unknown

Last updated

2019-04-23

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

Conditions

high risk acute myeloid leukemia

Interventions

G-CSF+Dicitabine:G-CSF(150ug d1-6) and dicitabine (5mg/m2 d2-6)

control:No intervention

Eligibility

Sex/Gender

All

Age

1 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. High risk AML patients 60-100 days after allo-HSCT and without aGVHD; 2. Aged 60,expected survival > 3 months; 3. No serious organ dysfunction; 4. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Have serious organ dysfunction; 2. Combined with other cancer need treatment; 3. Presence of clinical signs of brain dysfunction or severe mental illness can not comply with the study protocol; 4. Can not guarantee the completion of the treatment plan and the necessary follow-up observation.

Design outcomes

Primary

Measure	Time frame
relapse;	—

Secondary

Measure	Time frame
graft versus host disease;overall survival;disease free survival;	—

Countries

China

Contacts

Public ContactLei Gao

Department of Hematology, Xinqiao Hospital, Third Military Medical University

gaolei7765@163.com+86 13228689635

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 23, 2026