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

March 19, 2021 updated by: Hannover Medical School

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

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Target variables:

  • Treatment response
  • Event Free Survival
  • Leukemia Free Survival
  • Graft Versus Host Disease
  • Regimen related toxicity

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Graz University Hospital
      • Innsbruck, Austria, 6020
        • Innsbruck University Hospital
      • Wien, Austria, 1090
        • St. Anna Children Hospital
  • Czechia
      • Prag, Czechia, 15006
        • Teaching Hospital Motol
  • Germany
      • Berlin, Germany, 13353
        • Charité Campus Rudolf Virchow Hospital
      • Hamburg, Germany, 20246
        • Hamburg-Eppendorf University Hospital
    • Baden-Württemberg
      • Freiburg, Baden-Württemberg, Germany, 79106
        • University Hospital Freiburg
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • Heidelberg University Hospital
      • Tübingen, Baden-Württemberg, Germany, 72076
        • University children's hospital Tübingen
      • Ulm, Baden-Württemberg, Germany, 89075
        • University Children's Hospital Ulm
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • University Children's Hospital Erlangen-Nürnberg
      • München, Bavaria, Germany, 80337
        • Dr. von Haunersches Kinderspital
      • Würzburg, Bavaria, Germany, 97080
        • University Hospital Würzburg
    • Hesse
      • Frankfurt, Hesse, Germany, 60590
        • J.W. Goethe University Hospital and Faculty of Medicine
      • Gießen, Hesse, Germany, 35385
        • Gießen University Hospital
    • Lower Saxony
      • Hannover, Lower Saxony, Germany, 30625
        • Hannover Medical School, Department of Paediatrics, Paediatric Hematology and Oncology
    • Mecklenburg-West Pomerania
      • Greifswald, Mecklenburg-West Pomerania, Germany, 17475
        • University Hospital Greifswald
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Germany, 40225
        • Düsseldorf University Hospital
      • Essen, North Rhine-Westphalia, Germany, 45122
        • University Hospital Essen
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Munster University Hospital
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Carl Gustav Carus University Children's Hospital Dresden
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 06097
        • University Children's Hospital Halle
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • University Hospital Kiel
    • Thuringia
      • Jena, Thuringia, Germany, 07724
        • University Children's Hospital Jena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1

Group I: Relapsed AML-patients with blast cell reduction to <20% before the second course of induction therapy. These patients will receive conventional SCT.

Group II: Patients with non response to frontline treatment of AML, patients with blast cells <20% before the second course of induction therapy who do not achieve a second remission and relapsed AML-patients with blast cells >=20% before the second course of induction therapy. If these patients have a matched donor (MSD/MD) they will receive SCT with "FLAMSA".

Group III: Patients who are eligible for Group II but have no matched donor. These patients will receive SCT from a haploidentical donor.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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).
Time Frame: day 100
day 100
To evaluate whether "FLAMSA" increases leukemia free survival (LFS) and overall survival (OS) as compared to a historic control group
Time Frame: day 100
day 100
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.
Time Frame: day 100
day 100

Secondary Outcome Measures

Outcome Measure
Time Frame
Prospective evaluation of event free survival (EFS), LFS, and OS after SCT from either a MSD or a MUD
Time Frame: day 100
day 100
To evaluate whether it is feasible to standardize transplantation procedures in children with AML within the AML-Berlin/Frankfurt/Münster (BFM) study network
Time Frame: day 100
day 100
Decrease of transplantation associated mortality by standardized donor selection criteria
Time Frame: day 100
day 100
To further evaluate the contribution of immunomediated effects for the treatment of children suffering from very high risk AML
Time Frame: day 100
day 100
Prospective evaluation of late toxicities
Time Frame: day 100 and year 5
day 100 and year 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Investigators

  • Principal Investigator: Martin Sauer, Prof. Dr., Hannover Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2010

Primary Completion (ACTUAL)

February 24, 2021

Study Completion (ACTUAL)

February 24, 2021

Study Registration Dates

First Submitted

January 21, 2008

First Submitted That Met QC Criteria

February 1, 2008

First Posted (ESTIMATE)

February 4, 2008

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2021

Last Update Submitted That Met QC Criteria

March 19, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AML SCT-BFM 2007
  • 2007-004517-34 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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