Stem cell transplantation for young people with severe blood cancer

Phase 1

• Conditions: Relapsed or refractory Acute Myeloid Leukemia (AML); MedDRA version: 20.0 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 100000004864; MedDRA version: 20.0 Level: LLT Classification code 10067859 Term: Allogenic stem cell transplantation System Organ Class: 100000004865; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-004517-34-DE
• Lead Sponsor: Hannover Medical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-04-10
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 153

Inclusion Criteria

• Aged between 0-21 years
• Patients suffering from either refractory de novo AML or relapsed AML or patients with high risk AML in CR1 (As defined by AML as secondary malignancy (not MDS-related) or with high-risk cytogenetic aberrations like the following: 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), complex karyotype or WT1mut/FLT-ITD).
• 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

Are the trial subjects under 18? yes
Number of subjects for this age range: 150
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3
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