drugset / Trial / NCT00606723

Allogenic Stem Cell Transplantation for Children, Adolescents and Young Adults With Relapsed or Refractory AML

NCT00606723 ↗

Phase 3 Completed 154 enrolled Hannover Medical School
NaSingle-groupOpen-labelTreatment

Summary

1. To evaluate whether stem cell transplantation from a matched sibling donor is equivalent to a matched unrelated donor in in a second complete remission of acute myeloid leukemia (AML). 2. To evaluate whether stem cell transplantation (SCT) after chemotherapy (FLAMSA-schema) increases survival compared to a threshold derived from historical data 3. To evaluate whether SCT from haploidentical donors for children having no matched donor will result in better survival with acceptable toxicity.

Timeline

Start
2010-04
Primary completion
2021-02-24
Completion
2021-02-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Hematopoietic stem cells from bone marrow or peripheral blood Unknown 4e+06 cells/kg Intravenous
Subject Hematopoietic stem cells from bone marrow or peripheral blood Unknown 2e+08 cells/kg Intravenous