Patienten im Alter 18-60 Jahre die an einer akuten myeloischen Leukämie (AML) erkrankt sind, ein zytogentisches Standardrisiko aufweisen, nach 1-2 Chemotherapiezyklen (Induktionstherapie) eine komplette Remission erreicht haben (<5% Blasten im Knochenmark) und für die ein Stammzellspender verfügbar ist, werden entweder mit Chemotherapie (Konsolidierungstherapie) weiterbehandelt oder erhalten eine Stammzelltransplantation. Die Zuteilung zu einem der beiden Behandlungsarme erfolgt per Zufall.

Randomisierte Studie zur allogenen hämatopoetischen Stammzelltransplantation im Vergleich zur Standardchemotherapie bei Patienten in erster kompletter Remission im Alter von <=60 Jahren mit AML intermediären Risikos (Standardrisiko) und HLA-kompatiblem Geschwister- oder Fremdspender - ETAL-1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019377-15-DE

Enrollment

356

Registered

2010-04-14

Start date

2010-11-04

Completion date

Unknown

Last updated

2020-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic stem cell transplantation in patients with newly diagnoses AML =60 years of age in intermediate risk, after first complete response in comparison to standard consolidation chemotherapy MedDRA version: 17.1 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 100000004864

Interventions

Trade Name: no trade name

Allogeneic Hematopoietic Stem Cells for Transplantation Product Name: no trade name

hematopoietic stem cells Product Code: - Pharmaceutical Form: Infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • AML in first remission • cytological standard risk, i.e. karyotype not listed under exclusion criteria • Identification of HLA-identical sibling or HLA-compatible related or unrelated donor (9/10 HLA-alleles matched, high resolution typing for HLA-A, B, Cw, DRB1 and DQB1) • age: 18 - 60 years • medically fit for allogeneic stem cell transplantation • CR / CRi after induction therapy Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 356 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: • core-binding factor leukemia (t(8;21), inv16) • acute promyelocytic leukemia (t(15;17) • complex aberrant karyotype • karyotypes: -7; -5; del5q; t(3;3); t(6;11), t(6;9), 11q aberrations, trisomy 8 ± one single additional aberration, t(9;11) • pregnancy / nursing • non-compliance

Design outcomes

Primary

Measure	Time frame
Main Objective: To define the role of allogeneic stem cell transplantation in patients =60 years with intermediate-risk acute myeloid leukemia in first complete remission. According to the primary hypothesis, four years after randomisation, a 15% survival advantage of allogeneic stem cell transplantation (60% vs. 45%) compared to conventional postremission therapy is assumed.;Secondary Objective: - Disease-free survival - Cumulative incidence of relapse - Cumulative incidence of non-relapse mortality - Quality of life ;Primary end point(s): The primary efficacy end-point is overall survival from first complete remission (CR) 4 years after randomisation evaluated for each study arm in accordance with intention-to-treat.;Timepoint(s) of evaluation of this end point: year 1+2: every 3 months year 3+4: every 6 months	—

Measure

Time frame

Main Objective: To define the role of allogeneic stem cell transplantation in patients =60 years with intermediate-risk acute myeloid leukemia in first complete remission. According to the primary hypothesis, four years after randomisation, a 15% survival advantage of allogeneic stem cell transplantation (60% vs. 45%) compared to conventional postremission therapy is assumed.;Secondary Objective: - Disease-free survival - Cumulative incidence of relapse - Cumulative incidence of non-relapse mortality - Quality of life ;Primary end point(s): The primary efficacy end-point is overall survival from first complete remission (CR) 4 years after randomisation evaluated for each study arm in accordance with intention-to-treat.;Timepoint(s) of evaluation of this end point: year 1+2: every 3 months year 3+4: every 6 months

—

Secondary

Measure	Time frame
Secondary end point(s): Event-free survival Cumulative incidence of relapse Cumulative incidence of non-relapse mortality Quality of Life;Timepoint(s) of evaluation of this end point: year 1+2: every 3 months year 3+4: every 6 months	—

Countries

Germany

Contacts

Public ContactMK1, Bereich Klinische Studien

Universitätsklinikum Dresden

christoph.roellig@uniklinikum-dresden.de+4903514583775

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026