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

NCT ID: NCT00606723

Last Updated: 2021-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2021-02-24

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

Conditions

Acute Myeloid Leukemia (AML)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Hematopoietic stem cells from bone marrow or peripheral blood

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

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)

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hannover Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Sauer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Locations

Graz University Hospital

Graz, , Austria

Innsbruck University Hospital

Innsbruck, , Austria

St. Anna Children Hospital

Vienna, , Austria

Teaching Hospital Motol

Prague, , Czechia

University Hospital Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Heidelberg University Hospital

Heidelberg, Baden-Wurttemberg, Germany

University Children's Hospital Tübingen

Tübingen, Baden-Wurttemberg, Germany

University Children's Hospital Ulm

Ulm, Baden-Wurttemberg, Germany

University Children's Hospital Erlangen-Nürnberg

Erlangen, Bavaria, Germany

Dr. von Haunersches Kinderspital

München, Bavaria, Germany

University Hospital Würzburg

Würzburg, Bavaria, Germany

J.W. Goethe University Hospital and Faculty of Medicine

Frankfurt am Main, Hesse, Germany

Gießen University Hospital

Giessen, Hesse, Germany

Hannover Medical School, Department of Paediatrics, Paediatric Hematology and Oncology

Hanover, Lower Saxony, Germany

University Hospital Greifswald

Greifswald, Mecklenburg-West Pomerania, Germany

Düsseldorf University Hospital

Düsseldorf, North Rhine-Westphalia, Germany

University Hospital Essen

Essen, North Rhine-Westphalia, Germany

Münster University Hospital

Münster, North Rhine-Westphalia, Germany

Carl Gustav Carus University Children's Hospital Dresden

Dresden, Saxony, Germany

University Children's Hospital Halle

Halle, Saxony-Anhalt, Germany

University Hospital Kiel

Kiel, Schleswig-Holstein, Germany

University Children's Hospital Jena

Jena, Thuringia, Germany

Charité Campus Rudolf Virchow Hospital

Berlin, , Germany

Hamburg-Eppendorf University Hospital

Hamburg, , Germany

Countries

Austria; Czechia; Germany

Other Identifiers

2007-004517-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AML SCT-BFM 2007

Identifier Type: -

Identifier Source: org_study_id