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

Phase 3

Completed

• Conditions: Acute Myeloid Leukemia (AML)

• Registration Number: NCT00606723
• Lead Sponsor: Hannover Medical School

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 Timeline

• Study First Submitted: 2008-01-21
• Study First Submitted QC: 2008-02-01
• Study First Posted: 2008-02-04
• Study Start: 2010-04
• Primary Completion: 2021-02-24
• Study Completion: 2021-02-24
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-19
• Last Update Posted: 2021-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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).	day 100
To evaluate whether "FLAMSA" increases leukemia free survival (LFS) and overall survival (OS) as compared to a historic control group	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.	day 100

Secondary Outcome Measures

Name	Time	Method
Prospective evaluation of event free survival (EFS), LFS, and OS after SCT from either a MSD or a MUD	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	day 100
Prospective evaluation of late toxicities	day 100 and year 5
Decrease of transplantation associated mortality by standardized donor selection criteria	day 100
To further evaluate the contribution of immunomediated effects for the treatment of children suffering from very high risk AML	day 100

Trial Locations

Locations (24)

Graz University Hospital; 🇦🇹 Graz, Austria

Innsbruck University Hospital; 🇦🇹 Innsbruck, Austria

St. Anna Children Hospital; 🇦🇹 Wien, Austria

Teaching Hospital Motol; 🇨🇿 Prag, Czechia

University Hospital Freiburg; 🇩🇪 Freiburg, Baden-Württemberg, Germany

Heidelberg University Hospital; 🇩🇪 Heidelberg, Baden-Württemberg, Germany

University Children's Hospital Tübingen; 🇩🇪 Tübingen, Baden-Württemberg, Germany

University Children's Hospital Ulm; 🇩🇪 Ulm, Baden-Württemberg, Germany

University Children's Hospital Erlangen-Nürnberg; 🇩🇪 Erlangen, Bavaria, Germany

Dr. von Haunersches Kinderspital; 🇩🇪 München, Bavaria, Germany

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