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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 : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Hannover Medical School

Study Description
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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.

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

Detailed Description:

Target variables:

  • Treatment response
  • Event Free Survival
  • Leukemia Free Survival
  • Graft Versus Host Disease
  • Regimen related toxicity
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : April 2010
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. To evaluate whether "FLAMSA" increases leukemia free survival (LFS) and overall survival (OS) as compared to a historic control group [ Time Frame: day 100 ]
  3. 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 Measures :
  1. Prospective evaluation of event free survival (EFS), LFS, and OS after SCT from either a MSD or a MUD [ Time Frame: day 100 ]
  2. 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 ]
  3. Decrease of transplantation associated mortality by standardized donor selection criteria [ Time Frame: day 100 ]
  4. To further evaluate the contribution of immunomediated effects for the treatment of children suffering from very high risk AML [ Time Frame: day 100 ]
  5. Prospective evaluation of late toxicities [ Time Frame: day 100 and year 5 ]

Eligibility Criteria
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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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 (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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606723


Locations
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Sponsors and Collaborators
Hannover Medical School
Investigators
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Principal Investigator: Martin Sauer, Prof. Dr. Hannover Medical School
More Information
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Responsible Party: Hannover Medical School
ClinicalTrials.gov Identifier: NCT00606723    
Other Study ID Numbers: AML SCT-BFM 2007
2007-004517-34 ( EudraCT Number )
First Posted: February 4, 2008    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Keywords provided by Hannover Medical School:
relapsed or refractory AML
in children, adolescents and young adults
Additional relevant MeSH terms:
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Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms