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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Hannover Clinical Trial Center GmbH
Sponsor:
Information provided by (Responsible Party):
Hannover Clinical Trial Center GmbH
ClinicalTrials.gov Identifier:
NCT00606723
First received: January 21, 2008
Last updated: December 17, 2012
Last verified: December 2012
  Purpose
  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.

Condition Intervention Phase
Acute Myeloid Leukemia (AML)
Biological: Hematopoietic stem cells from bone marrow or peripheral blood
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Allogenic Stem Cell Transplantation for Children, Adolescents and Young Adults With Relapsed or Refractory AML; Multi Center Therapy Concept

Resource links provided by NLM:


Further study details as provided by Hannover Clinical Trial Center GmbH:

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). [ Time Frame: day 100 ] [ Designated as safety issue: Yes ]
  • To evaluate whether "FLAMSA" increases leukemia free survival (LFS) and overall survival (OS) as compared to a historic control group [ Time Frame: day 100 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Prospective evaluation of event free survival (EFS), LFS, and OS after SCT from either a MSD or a MUD [ Time Frame: day 100 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Decrease of transplantation associated mortality by standardized donor selection criteria [ Time Frame: day 100 ] [ Designated as safety issue: Yes ]
  • To further evaluate the contribution of immunomediated effects for the treatment of children suffering from very high risk AML [ Time Frame: day 100 ] [ Designated as safety issue: Yes ]
  • Prospective evaluation of late toxicities [ Time Frame: day 100 and year 5 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 136
Study Start Date: April 2010
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

Target variables:

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

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Pregnant or lactating females
  • Current participation in another clinical trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606723

Contacts
Contact: Martin Sauer, Prof. Dr. +49-511-532 ext 3220 sauer.martin@mh-hannover.de
Contact: Arndt Borkhardt, Prof. Dr. +49-211-811 ext 7680 arndt.borkhardt@med.uni-duesseldorf.de

Locations
Austria
Graz University Hospital Recruiting
Graz, Austria, 8036
Innsbruck University Hospital Recruiting
Innsbruck, Austria, 6020
St. Anna Children Hospital Recruiting
Wien, Austria, 1090
Czech Republic
Teaching Hospital Motol Recruiting
Prag, Czech Republic, 15006
Germany
University Hospital Freiburg Recruiting
Freiburg, Baden-Württemberg, Germany, 79106
Heidelberg University Hospital Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
University Children's Hospital Tübingen Recruiting
Tübingen, Baden-Württemberg, Germany, 72076
University Children's Hospital Ulm Recruiting
Ulm, Baden-Württemberg, Germany, 89075
University Children's Hospital Erlangen-Nürnberg Recruiting
Erlangen, Bavaria, Germany, 91054
Dr. von Haunersches Kinderspital Recruiting
München, Bavaria, Germany, 80337
Regensburg University Hospital Recruiting
Regensburg, Bavaria, Germany, 93053
University Hospital Würzburg Recruiting
Würzburg, Bavaria, Germany, 97080
J.W. Goethe University Hospital and Faculty of Medicine Recruiting
Frankfurt, Hesse, Germany, 60590
Gießen University Hospital Recruiting
Gießen, Hesse, Germany, 35385
Hannover Medical School, Department of Paediatrics, Paediatric Hematology and Oncology Recruiting
Hannover, Lower Saxony, Germany, 30625
University Hospital Greifswald Not yet recruiting
Greifswald, Mecklenburg-West Pomerania, Germany, 17475
Düsseldorf University Hospital Recruiting
Düsseldorf, North Rhine-Westphalia, Germany, 40225
University Hospital Essen Recruiting
Essen, North Rhine-Westphalia, Germany, 45122
Münster University Hospital Recruiting
Münster, North Rhine-Westphalia, Germany, 48149
University Children's Hospital Halle Recruiting
Halle, Saxony-Anhalt, Germany, 06097
Carl Gustav Carus University Children's Hospital Dresden Not yet recruiting
Dresden, Saxony, Germany, 01307
University Hospital Kiel Recruiting
Kiel, Schleswig-Holstein, Germany, 24105
University Children's Hospital Jena Recruiting
Jena, Thuringia, Germany, 07724
Charité Campus Rudolf Virchow Hospital Not yet recruiting
Berlin, Germany, 13353
Hamburg-Eppendorf University Hospital Recruiting
Hamburg, Germany, 20246
Sponsors and Collaborators
Hannover Clinical Trial Center GmbH
Investigators
Principal Investigator: Martin Sauer, Prof. Dr. Hannover Medical School
  More Information

No publications provided

Responsible Party: Hannover Clinical Trial Center GmbH
ClinicalTrials.gov Identifier: NCT00606723     History of Changes
Other Study ID Numbers: AML SCT-BFM 2007, 2007-004517-34
Study First Received: January 21, 2008
Last Updated: December 17, 2012
Health Authority: Germany: Paul-Ehrlich-Institut
Czech Republic: Ethics Committee
Austria: Ethikkommission
Switzerland: Ethikkommission

Keywords provided by Hannover Clinical Trial Center GmbH:
relapsed or refractory AML
in children, adolescents and young adults

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 25, 2014