NCT00606723

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

Allogenic Stem Cell Transplantation for Children, Adolescents and Young Adults With Relapsed or Refractory AML; Multi Center Therapy Concept

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Hannover Medical School · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Target variables: * Treatment response * Event Free Survival * Leukemia Free Survival * Graft Versus Host Disease * Regimen related toxicity

Conditions

• Acute Myeloid Leukemia (AML)

Interventions

Type	Name	Description
BIOLOGICAL	Hematopoietic stem cells from bone marrow or peripheral blood	\> = 2 x 10\*8 nucleated cells (WBC)/kg body weight of the recipient or rather \> = 4 x 10\*6 nucleated CD34+ cells / kg body weight are required for engraftment. Suspension of stem cells is administered via intravenous infusion.

Timeline

• Start date: 2010-04-01
• Primary completion: 2021-02-24
• Completion: 2021-02-24
• First posted: 2008-02-04
• Last updated: 2021-03-22

Locations

24 sites across 3 countries: Austria, Czechia, Germany