FindTrial
Sign In

Clinical study on the efficacy and safety of TBMF pretreatment scheme for allogeneic hematopoietic stem cell transplantation in elderly patients with acute myeloid leukemia (AML)

Clinical study on the efficacy and safety of TBMF pretreatment scheme for allogeneic hematopoietic stem cell transplantation in elderly patients with acute myeloid leukemia (AML)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106012
Enrollment
Unknown
Registered
2025-07-15
Start date
2025-07-21
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Acute myeloid leukemia patients

Interventions

Treatment group:After screening and enrollment, the patient received the following drug treatments: Cetriptyline 5 mg/kg/d, D-3 to -2
Baixiao'an 0.8mg/m2/d. D-6 to -5
Mafran 110mg/m2/d, D-4
Fludarabine 30mg/m2/d, D-6 to -2
D0 transfusion of hematopoietic stem cells.

Sponsors

Guangdong Provincial Hosipital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age range of 55-70 years old; 2. Diagnosed AML patients; 3. Plan to receive allogeneic hematopoietic stem cell transplantation treatment; 4. ECOG score 0-2 points; 5. Expected survival period >= 3 months; 6. The main organ functions are normal, and laboratory results on test meet the following criteria: a) Alanine aminotransferase (ALT) <= 3.0 × upper limit of normal (ULN), aspartate aminotransferase (AST) <= 3.0 × ULN; b) Serum total bilirubin <= 1.5 × ULN; c) Serum creatinine <= 1.5 × ULN; 7. Voluntarily participate in this clinical trial, understand the research procedures, and be able to sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. There are other hematological diseases that affect bone marrow hematopoietic function; 3. Individuals who are allergic to research drugs and related metabolites; 4. Uncontrollable active infections; 5. According to the researcher's judgment, there are serious accompanying diseases that pose a threat to patient safety or affect the completion of the study; 6. Other situations deemed unsuitable for inclusion in this study by the researcher.

Design outcomes

Primary

MeasureTime frame
1-Year Overall Survival Rate;—

Secondary

MeasureTime frame
1-Year Progression-Free Survival Rate;Complete remission rate after transplantation;1-year recurrence and progression rate;Transplantation related mortality rate;—

Countries

China

Contacts

Public ContactYuanbin Wu

Guangdong Provincial Hosipital of Chinese Medicine

wuyuanbin1977@sohu.com+86 137 1145 4979

Outcome results

None listed

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