Haematopoietic Stem Cell Transplantation (HSCT) in Comparison to Conventional Consolidation Therapy for Patients With Acute Myeloid Leukemia (AML) (Intermediate Risk) </= 60y. After First CR

Randomised Trial on Allogeneic Haematopoietic Stem Cell Transplantation in Patients Under the Age of 60 Years With Acute Myeloid Leukemia of Intermediate Risk in First Complete Remission and a Matched Sibling or Unrelated Donor (ETAL-1)

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01246752

Acronym

AML

Enrollment

143

Registered

2010-11-23

Start date

2011-02-10

Completion date

2020-04-30

Last updated

2021-10-29

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

Conditions

Leukemia, Myeloid, Acute

Keywords

AML, Leukemia, Acute Myeloid Leukemia, HSCT, Stem Cell Transplantation, Tx, Chemotherapy

Brief summary

Hematopoietic stem cell transplantation in patients with newly diagnosed AML ≤60 years of age in intermediate risk, after first complete response in comparison to standard consolidation chemotherapy

Interventions

BIOLOGICALHuman Stem Cell Transplantation

Human allogenic stem cells

DRUGConsolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC)

Consolidation chemotherapy, recommended regimen: HiDAC = 3 x 2g/sqm BID on days 1,3,5

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Percent of Patients alive after 4 years (Overall Survival)	4 years	The status of each patient alive/not alive is surveyed every 3 months in year 1+2 and every 6 months in year 3+4 after randomisation.

Secondary

Measure	Time frame	Description
Disease-free survival	4 years	—
Cumulative incidence of relapse	4 years	—
Cumulative incidence of non-relapse mortality	4 years	—
Quality of life assessed by questionnaires	4 years	Scores assessed by validated questionnaires (8 subscales: physical function, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026