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Treatment of High-Risk Acute Myeloid Leukemia With Cladribine, Cytarabine, Mitoxantrone, and Granulocyte Colony-Stimulating Factor Then Subsequent Bridging to Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation:single center, single arm clinical study

Treatment of High-Risk Acute Myeloid Leukemia With Cladribine, Cytarabine, Mitoxantrone, and Granulocyte Colony-Stimulating Factor Then Subsequent Bridging to Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation:single center, single arm clinical study

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900025458
Enrollment
Unknown
Registered
2019-08-26
Start date
2019-09-01
Completion date
Unknown
Last updated
2019-08-27

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

Case series:CLAG-M Bridging to HSCT

Sponsors

Department of Hematology, the Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. male and female aged 14~55 years old; 2. diagnosis with refractory / recurrent acute myeloid leukemia: (1) Patients were treated with standard induced remission regimen for 2 courses but didn't achieve remission . (2) Those who recur within 6 months after the first remission, also known as early recurrence. (3) Recurrence occurred 6 months after the first remission, but the original induced remission regimen failed to achieve CR again. (4) Secondary or multiple recurrence. (5) Recurrence after transplantation. 4. ECOG score 0~2; 5. HLA-Matched donor is available; 6. normal cardiac function: ejection fraction >=50%; 7. blood bilirubin <=35 umol/L, AST/ALT below 2 times the upper limit of normal value; 8. serum creatinine <=130 umol/L; 9. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1 diagnosed as AML-M3 according to FAB classification(acute promyelocytic leukemia); 2. severe infection was not controlled before transplantation; 3. non-myeloaball allogenic hematopoietic stem cell transplantation was performed; 4. patients with cardiac insufficiency (ejection fraction 34umol/L, AST/ALT >2 times the upper limit of normal value; 6. renal insufficiency (serum creatinine >130umol/L) 7. refused to participate in the study.

Design outcomes

Primary

MeasureTime frame
CR rate;overall survival rate;Disease-free survival rate;relapse rate;Mortality rate;

Secondary

MeasureTime frame
engraftment rate;Chemotherapeutic toxicity;acute and chronic complications associated in Allo-HSCT;

Countries

China

Contacts

Public ContactZhang Jingwen

Department of Hematology, the Third Affiliated Hospital of Sun Yat-sen University

linlin_jw@163.com+86 13430350179

Outcome results

None listed

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