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Completed

NCT Number: NCT00606723

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

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.

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Key information

Conditions

Acute Myeloid Leukemia (AML) Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Graz University Hospital, Graz, Austria

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About this study

Target variables:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hematopoietic stem cells from bone marrow or peripheral blood

Biological

> = 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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2021
Study completion
2021
First posted
Feb 4, 2008
Registry last updated
Mar 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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