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

Study Overview
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Brief Summary
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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

Official Title
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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)

Conditions
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Leukemia, Myeloid, Acute

Intervention / Treatment
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* Biological: Human Stem Cell Transplantation
* Drug: Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC)


Participation Criteria
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Eligibility Criteria
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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 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 pregnancy / nursing non-compliance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Human Stem Cell Transplantation<br>Patients receive an allogenic stem cell transplantation from an HLA-matched unrelated or related donor | Biological: Human Stem Cell Transplantation<br>* Human allogenic stem cells<br>|
| Active Comparator: Consolidating Chemotherapy<br>Patients receive a standard chemotherapy as consolidation therapy | Drug: Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC)<br>* Consolidation chemotherapy, recommended regimen: HiDAC = 3 x 2g/sqm BID on days 1,3,5<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Patients alive after 4 years (Overall Survival) | 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. | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Scores assessed by validated questionnaires (8 subscales: physical function, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health) | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AML, Leukemia, Acute Myeloid Leukemia, HSCT, Stem Cell Transplantation, Tx, Chemotherapy