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


Phase 3
N/A
21 Years
Open (Enrolling)
Both
Acute Myeloid Leukemia (AML)

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Trial Information

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


Target variables:

- Treatment response

- Event Free Survival

- Leukemia Free Survival

- Graft Versus Host Disease

- Regimen related toxicity


Inclusion Criteria:



- Aged between 0-21 years

- Patients suffering from either refractory de novo AML or relapsed AML or patients
with very high risk AML in CR1

- In sexually active patients two reliable contraception methods are used. This
includes every combination of a hormonal contraceptive (such as injection,
transdermal patch, implant, cervical ring) or of an intrauterine device(IUD) with a
barrier method (e.g. diaphragm, cervical cap, or condom) or with a spermicide.

- Written informed consent of patient, parents or legal guardians

Exclusion Criteria:

- Severe renal impairment

- Pregnant or lactating females

- Current participation in another clinical trial

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate whether stem cell transplantation (SCT) from a matched sibling donor (MSD) is equivalent to a matched unrelated donor (MUD) in second complete remission (CR2).

Outcome Time Frame:

day 100

Safety Issue:

Yes

Principal Investigator

Martin Sauer, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hannover Medical School

Authority:

Germany: Paul-Ehrlich-Institut

Study ID:

AML SCT-BFM 2007

NCT ID:

NCT00606723

Start Date:

April 2010

Completion Date:

July 2019

Related Keywords:

  • Acute Myeloid Leukemia (AML)
  • relapsed or refractory AML
  • in children, adolescents and young adults
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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