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

Primary Purpose

Acute Myeloid Leukemia (AML)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Hematopoietic stem cells from bone marrow or peripheral blood
Sponsored by
Hannover Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia (AML) focused on measuring relapsed or refractory AML, in children, adolescents and young adults

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Graz University Hospital
  • Innsbruck University Hospital
  • St. Anna Children Hospital
  • Teaching Hospital Motol
  • University Hospital Freiburg
  • Heidelberg University Hospital
  • University Children's Hospital Tübingen
  • University Children's Hospital Ulm
  • University Children's Hospital Erlangen-Nürnberg
  • Dr. von Haunersches Kinderspital
  • University Hospital Würzburg
  • J.W. Goethe University Hospital and Faculty of Medicine
  • Gießen University Hospital
  • Hannover Medical School, Department of Paediatrics, Paediatric Hematology and Oncology
  • University Hospital Greifswald
  • Düsseldorf University Hospital
  • University Hospital Essen
  • Münster University Hospital
  • University Children's Hospital Halle
  • Carl Gustav Carus University Children's Hospital Dresden
  • University Hospital Kiel
  • University Children's Hospital Jena
  • Charité Campus Rudolf Virchow Hospital
  • Hamburg-Eppendorf University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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.

Outcomes

Primary Outcome Measures

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).
To evaluate whether "FLAMSA" increases leukemia free survival (LFS) and overall survival (OS) as compared to a historic control group
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.

Secondary Outcome Measures

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

Full Information

First Posted
January 21, 2008
Last Updated
March 19, 2021
Sponsor
Hannover Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT00606723
Brief Title
Allogenic Stem Cell Transplantation for Children, Adolescents and Young Adults With Relapsed or Refractory AML
Official Title
Allogenic Stem Cell Transplantation for Children, Adolescents and Young Adults With Relapsed or Refractory AML; Multi Center Therapy Concept
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 2010 (Actual)
Primary Completion Date
February 24, 2021 (Actual)
Study Completion Date
February 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hannover Medical School

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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). To evaluate whether stem cell transplantation (SCT) after chemotherapy (FLAMSA-schema) increases survival compared to a threshold derived from historical data 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia (AML)
Keywords
relapsed or refractory AML, in children, adolescents and young adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Hematopoietic stem cells from bone marrow or peripheral blood
Intervention Description
> = 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.
Primary Outcome Measure Information:
Title
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
Title
To evaluate whether "FLAMSA" increases leukemia free survival (LFS) and overall survival (OS) as compared to a historic control group
Time Frame
day 100
Title
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
Secondary Outcome Measure Information:
Title
Prospective evaluation of event free survival (EFS), LFS, and OS after SCT from either a MSD or a MUD
Time Frame
day 100
Title
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
Title
Decrease of transplantation associated mortality by standardized donor selection criteria
Time Frame
day 100
Title
To further evaluate the contribution of immunomediated effects for the treatment of children suffering from very high risk AML
Time Frame
day 100
Title
Prospective evaluation of late toxicities
Time Frame
day 100 and year 5

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Sauer, Prof. Dr.
Organizational Affiliation
Hannover Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Graz University Hospital
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Innsbruck University Hospital
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
St. Anna Children Hospital
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Teaching Hospital Motol
City
Prag
ZIP/Postal Code
15006
Country
Czechia
Facility Name
University Hospital Freiburg
City
Freiburg
State/Province
Baden-Württemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Heidelberg University Hospital
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
University Children's Hospital Tübingen
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
University Children's Hospital Ulm
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89075
Country
Germany
Facility Name
University Children's Hospital Erlangen-Nürnberg
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany
Facility Name
Dr. von Haunersches Kinderspital
City
München
State/Province
Bavaria
ZIP/Postal Code
80337
Country
Germany
Facility Name
University Hospital Würzburg
City
Würzburg
State/Province
Bavaria
ZIP/Postal Code
97080
Country
Germany
Facility Name
J.W. Goethe University Hospital and Faculty of Medicine
City
Frankfurt
State/Province
Hesse
ZIP/Postal Code
60590
Country
Germany
Facility Name
Gießen University Hospital
City
Gießen
State/Province
Hesse
ZIP/Postal Code
35385
Country
Germany
Facility Name
Hannover Medical School, Department of Paediatrics, Paediatric Hematology and Oncology
City
Hannover
State/Province
Lower Saxony
ZIP/Postal Code
30625
Country
Germany
Facility Name
University Hospital Greifswald
City
Greifswald
State/Province
Mecklenburg-West Pomerania
ZIP/Postal Code
17475
Country
Germany
Facility Name
Düsseldorf University Hospital
City
Düsseldorf
State/Province
North Rhine-Westphalia
ZIP/Postal Code
40225
Country
Germany
Facility Name
University Hospital Essen
City
Essen
State/Province
North Rhine-Westphalia
ZIP/Postal Code
45122
Country
Germany
Facility Name
Münster University Hospital
City
Münster
State/Province
North Rhine-Westphalia
ZIP/Postal Code
48149
Country
Germany
Facility Name
University Children's Hospital Halle
City
Halle
State/Province
Saxony-Anhalt
ZIP/Postal Code
06097
Country
Germany
Facility Name
Carl Gustav Carus University Children's Hospital Dresden
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01307
Country
Germany
Facility Name
University Hospital Kiel
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
University Children's Hospital Jena
City
Jena
State/Province
Thuringia
ZIP/Postal Code
07724
Country
Germany
Facility Name
Charité Campus Rudolf Virchow Hospital
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Hamburg-Eppendorf University Hospital
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

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

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