Allogeneic stem cell transplantation for children, adolescents and young adults with relapsed or refractory AML - AML SCT-BFM 2007

Phase 1

• Conditions: To evaluate whether stem cell transplantation from a matched sibling donor is equivalent to a matched unrelated donor in a second complete remission; to evaluate whether stem cell transplantation after FLAMSA increases survival compared to a threshold derived from historical data (1-year Survival 10%); to evaluate whether stem cell transplantation from haploidentical donors for children having no matched donor will result in better survival with acceptable toxicity.; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2007-004517-34-AT
• Lead Sponsor: Hannover Clinical Trial Center GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-17
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

•Children, adolescents and young adults aged 0-21 years, male and female
•Patients suffering from refractory de novo AML
•Patients with relapsed AML
•Patients with very high risk AML in CR1
•Contraception of female adolescents and young adults of male partners
•Written informed consent of patient, parents or legal guardians
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Severe renal impairment (GFR <30% predicted for age)
•Pregnancy
•Current participation in antoher clinical trial (exception: AML BFM Frontline studies)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified