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A Prospective Clinical Study of TMLI as Conditioning Regimen for High-Risk Acute Leukemia

A Prospective Clinical Study of TMLI as Conditioning Regimen for High-Risk Acute Leukemia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500115687
Enrollment
Unknown
Registered
2025-12-30
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

High-Risk Acute Leukemia

Interventions

Two-dimensional radiotherapy observation group:None
Helical tomographic intensity-modulated radiotherapy observation group:None
Observation group exempted from helical tomographic intensity-modulated radiotherapy for the liver and spleen:None

Sponsors

Capital Medical University Cancer Canter, Beijing Shijitan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Age: >=18 years old, and 70 points; 3. Clinically diagnosed as acute myeloid leukemia, with no response to induction remission therapy, or recurrence within 6 to 12 months of the first remission, or recurrence after 6 to 12 months of the first remission with no response to the original induction regimen, or recurrence after two or more times; 4. Intended allogeneic hematopoietic stem cell transplantation (either fully matched or semi-matched is acceptable); 5. The subjects voluntarily joined this study, signed written informed consent forms before the implementation of any trial-related procedures, had good compliance and cooperated with the follow-up. 6. The expected survival period is more than 3 months; 7. Normal liver function (normal bilirubin, ALT/AST 50ml/min), and basically normal cardiopulmonary function.

Exclusion criteria

Exclusion criteria: 1.For research subjects without a clear diagnosis, the M3 subtype is excluded. 2. Has received radiotherapy before; 3. Enlarged liver or spleen, or imaging, cytological and other examinations suggesting liver or spleen involvement; 4. Acute myeloid leukemia transformed from myelodysplastic syndrome, etc. 5. HIV, acute infection, active hepatitis, active pulmonary tuberculosis; 6. History of dysfunction of vital organs and malignant tumors; 7. History of mental illness; 8. Has received autologous hematopoietic stem cell transplantation or organ transplantation; 9. Pregnant and lactating women and subjects of childbearing age who are unwilling to take contraceptive measures.

Design outcomes

Primary

MeasureTime frame
Time of hematopoietic reconstitution;30-day mortality rate after transplantation;100-day mortality rate after transplantation;

Secondary

MeasureTime frame
12 months PFS;12 months OS;Incidence rate of interstitial pneumonia;Incidence rate of hepatotoxicity;Incidence rate of nephrotoxicity;

Countries

China

Contacts

Public ContactLinan Song

Capital Medical University Cancer Canter, Beijing Shijitan Hospital

sln_sjt@sina.com+86 10 6392 5719

Outcome results

None listed

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