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Efficacy and safety of conditioning including idarubicin and antithymocyte globulin in sibling donor allogeneic hematopoietic stem cell transplantation for standard-risk acute leukemia

Efficacy and safety of conditioning including idarubicin and antithymocyte globulin in sibling donor allogeneic hematopoietic stem cell transplantation for standard-risk acute leukemia

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIN-16007780
Enrollment
Unknown
Registered
2016-01-17
Start date
2016-01-01
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 leukemia

Interventions

one:conditioning including idarubicin and antithymocyte globulin

Sponsors

The First Affilited Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Standard-risk acute leukemia; 2. Age: 18 to 40 years old; Gender: Male or female; 3. Patients in the first complete remission(CR1); 4. HLA-matched or one allele mismatched sibling donor allogeneic hematopoietic stem cell transplantation; 5. In good general condition, ECOG score less than 1; 6. Enrolled patients signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Cardiac dysfunction (ejection fraction less than 60%); Lung function insufficiency(obstruction and/or restrictive ventilatory disorders); Hepatic dysfunction (total bilirubin more than 34umol/L, ALTAST more than 2 times the upper limit of normal); Renal insufficiency (serum creatinine more than 130umol/L); 2. Severe invasive fungal infections uncontrolled before transplantation; 3. Contraindicated in using IDA, IDA total cumulative dose up to 300 mg/m2; 4. Severe allergic on Antithymocyte globulin (anaphylactic shock or laryngeal edema); 5. Unrelated donor or autologous allogeneic hematopoietic stem cell transplantation; reduced-intensity conditioning transplantation; 6. Other circumstances which do not meet the inclusion criteria.

Design outcomes

Primary

MeasureTime frame
the relapse of leukemia post-transplantation;graft-versus-host disease post-transplantation;2-years OS post-transplantation;2-years DFS post-tansplantation;

Countries

China

Contacts

Public ContactYongrong Lai
laiyongrong@263.net13517711828

Outcome results

None listed

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