Allogeneic stem cell transplantation for children, adolescents and young adults with acute myeloid leukemia

Phase 1

• Conditions: To evaluate whether stem cell transplantation from a matched sibling donor is equivalent to a matched unrelated donor in a second complete remission; to evaluate whether stem cell transplantation after FLAMSA increases survival compared to a threshold derived from historical data (1-year pSurvival 10%); to evaluate whether stem cell transplantation from haploidentical donors for children having no matched donor will result in better survival with acceptable toxicity.; MedDRA version: 18.1Level: LLTClassification code 10067859Term: Allogenic stem cell transplantationSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2007-004517-34-CZ
• Lead Sponsor: Hannover Clinical Trial Center GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-10
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 153

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
*AML is defined according to the WHO criteria in Tumours of Haematopoietic and Lymphoid Tissues, edited by ES Jaffe, NL Harris, H Stein, and JW Vardiman, page 75, IARC press,
Lyon 2001 (see also AML-BFM 2004 page 36 and current MRC 15 trial).
**As defined by the following aberrations: 12p, monosomy 7, t(4;11), t(5;11), t(6;11), t(6;9), t(7;12), t(9;22), t(8;16), t(10;11), and complex karyotype or WT1mut/FLT-ITD or AML as secondary malignancy (not MDS-related)

Are the trial subjects under 18? yes
Number of subjects for this age range: 145
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product
• Study Design: Not specified