Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00606723
Recruitment Status : Active, not recruiting
First Posted : February 4, 2008
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Hannover Medical School

Tracking Information
First Submitted Date  ICMJE January 21, 2008
First Posted Date  ICMJE February 4, 2008
Last Update Posted Date June 7, 2019
Actual Study Start Date  ICMJE April 2010
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2008)
  • 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 ]
  • To evaluate whether "FLAMSA" increases leukemia free survival (LFS) and overall survival (OS) as compared to a historic control group [ Time Frame: 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2008)
  • Prospective evaluation of event free survival (EFS), LFS, and OS after SCT from either a MSD or a MUD [ Time Frame: 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 ]
  • Decrease of transplantation associated mortality by standardized donor selection criteria [ Time Frame: 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 ]
  • Prospective evaluation of late toxicities [ Time Frame: day 100 and year 5 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Allogenic Stem Cell Transplantation for Children, Adolescents and Young Adults With Relapsed or Refractory AML
Official Title  ICMJE Allogenic Stem Cell Transplantation for Children, Adolescents and Young Adults With Relapsed or Refractory AML; Multi Center Therapy Concept
Brief 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.
Detailed Description

Target variables:

  • Treatment response
  • Event Free Survival
  • Leukemia Free Survival
  • Graft Versus Host Disease
  • Regimen related toxicity
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myeloid Leukemia (AML)
Intervention  ICMJE 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.
Study Arms  ICMJE 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.

Intervention: Biological: Hematopoietic stem cells from bone marrow or peripheral blood
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 1, 2016)
154
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2008)
140
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Czechia,   Germany
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00606723
Other Study ID Numbers  ICMJE AML SCT-BFM 2007
2007-004517-34 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hannover Medical School
Study Sponsor  ICMJE Hannover Medical School
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Martin Sauer, Prof. Dr. Hannover Medical School
PRS Account Hannover Medical School
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP