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

Acute Myeloid Leukemia (AML) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00606723
• Other study ID #: AML SCT-BFM 2007
• Secondary ID: 2007-004517-34
• Status: Completed
• Phase: Phase 3
• Start date: April 2010
• Est. completion date: February 24, 2021

Study information

• Verified date: March 2021
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Target variables:

• Treatment response

• Event Free Survival

• Leukemia Free Survival

• Graft Versus Host Disease

• Regimen related toxicity

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: February 24, 2021
• Est. primary completion date: February 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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 (GFR < 30% predicted for age)

• Pregnant or lactating females

• Current participation in another clinical trial

• Patients = 12 years old for Group 1 ("BuCyMel") (patients younger that 12 years continue to be included)

Related Conditions & MeSH terms

• Acute Myeloid Leukemia (AML)
• Leukemia, Myeloid, Acute

Intervention

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.

Locations

Country	Name	City	State
Austria	Graz University Hospital	Graz
Austria	Innsbruck University Hospital	Innsbruck
Austria	St. Anna Children Hospital	Wien
Czechia	Teaching Hospital Motol	Prag
Germany	Charité Campus Rudolf Virchow Hospital	Berlin
Germany	Carl Gustav Carus University Children's Hospital Dresden	Dresden	Saxony
Germany	Düsseldorf University Hospital	Düsseldorf	North Rhine-Westphalia
Germany	University Children's Hospital Erlangen-Nürnberg	Erlangen	Bavaria
Germany	University Hospital Essen	Essen	North Rhine-Westphalia
Germany	J.W. Goethe University Hospital and Faculty of Medicine	Frankfurt	Hesse
Germany	University Hospital Freiburg	Freiburg	Baden-Württemberg
Germany	Gießen University Hospital	Gießen	Hesse
Germany	University Hospital Greifswald	Greifswald	Mecklenburg-West Pomerania
Germany	University Children's Hospital Halle	Halle	Saxony-Anhalt
Germany	Hamburg-Eppendorf University Hospital	Hamburg
Germany	Hannover Medical School, Department of Paediatrics, Paediatric Hematology and Oncology	Hannover	Lower Saxony
Germany	Heidelberg University Hospital	Heidelberg	Baden-Württemberg
Germany	University Children's Hospital Jena	Jena	Thuringia
Germany	University Hospital Kiel	Kiel	Schleswig-Holstein
Germany	Dr. von Haunersches Kinderspital	München	Bavaria
Germany	Münster University Hospital	Münster	North Rhine-Westphalia
Germany	University Children's Hospital Tübingen	Tübingen	Baden-Württemberg
Germany	University Children's Hospital Ulm	Ulm	Baden-Württemberg
Germany	University Hospital Würzburg	Würzburg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Countries where clinical trial is conducted

Austria,  Czechia,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		day 100
Primary	To evaluate whether "FLAMSA" increases leukemia free survival (LFS) and overall survival (OS) as compared to a historic control group		day 100
Primary	To evaluate whether SCT from haploidentical donors for children having no matched donor will result in an acceptable toxicity profile and a better LFS as compared to historic controls.		day 100
Secondary	Prospective evaluation of event free survival (EFS), LFS, and OS after SCT from either a MSD or a MUD		day 100
Secondary	To evaluate whether it is feasible to standardize transplantation procedures in children with AML within the AML-Berlin/Frankfurt/Münster (BFM) study network		day 100
Secondary	Decrease of transplantation associated mortality by standardized donor selection criteria		day 100
Secondary	To further evaluate the contribution of immunomediated effects for the treatment of children suffering from very high risk AML		day 100
Secondary	Prospective evaluation of late toxicities		day 100 and year 5