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The effect and safety of high-dose chemotherapy combined with allogeneic hematopoietic stem cell enfusion in patients with relapsed / refractory acute myeloid leukemia

The effect and safety of high-dose chemotherapy combined with allogeneic hematopoietic stem cell enfusion in patients with relapsed / refractory acute myeloid leukemia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONRC-13003482
Enrollment
Unknown
Registered
2013-04-24
Start date
2013-09-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

acute myeloid leukemia

Interventions

Group of stem cell infusion:Chemotherapy+stem cell infusion

Sponsors

The First Affiliated Hospital of Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 59 Years

Inclusion criteria

Inclusion criteria: 1. Subjects or their legal representatives should signed informed consent; 2. Male or non-pregnant female; 3. Subjects must younger than 60, and the expected survival is 3 months or more; 4. The score of ECOG physical status must be 0 to 2; 5. The laboratory values should be (unless caused by the leukemia): creatinine clearance >=50mL/min, or serum creatinine <=1.5mg/dl, and bilirubin <=2 times the upper limit of normal; 6. Subjects must have been restored to <=1 degree of all non-hematologic toxicity (NCI CTC AE3.0 Edition) which have been from the previous treatment; 7. Subjects were diagnosed of relapsed / refractory acute myeloid leukemia patients, according to FAB, or WHO diagnostic criteria.

Exclusion criteria

Exclusion criteria: 1. The patients were diagnosed of acute lymphoblastic leukemia, or acute mixed cell leukemia, or acute promyelocytic leukemia; 2. The patients have been used FLAG regimen, and clearly ineffective; 3. The patients with severe liver, kidney, or cardiopulmonary dysfunction; 4. The patients had uncontrolled or severe heart disease or infection, or mental illness; 5. The patients had received allogeneic hematopoietic stem cell transplantation; 6. The patients had other malignancies(unless the patients have completed treatment and doctors believe impossible relapse within 1 year).

Design outcomes

Primary

MeasureTime frame
Complete remission rate;Overall response rate ;

Secondary

MeasureTime frame
Safety;Disease free survival;Progression-free survival;Overall survival;

Contacts

Public ContactHe Huang
hehuangyu@126.com+86 571 87236703

Outcome results

None listed

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