Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): decreased recrucial rate as the likelihood of achieving the envisioned patient number in a realistic time-frame was very low.
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC) | Drug | — | UNRESOLVED |
| Human Stem Cell Transplantation | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Human Stem Cell Transplantation
- description
- Patients receive an allogenic stem cell transplantation from an HLA-matched unrelated or related donor
- interventionNames
- Biological: Human Stem Cell Transplantation
- type
- ACTIVE_COMPARATOR
- label
- Consolidating Chemotherapy
- description
- Patients receive a standard chemotherapy as consolidation therapy
- interventionNames
- Drug: Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC)
Primary outcomes (1)
- measure
- Percent of Patients alive after 4 years (Overall Survival)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBornhauser M, Schliemann C, Schetelig J, Rollig C, Kramer M, Glass B, Platzbecker U, Burchert A, Hanel M, Muller LP, Klein S, Bug G, Beelen D, Rosler W, Schafer-Eckart K, Schmid C, Jost E, Lenz G, Tischer J, Spiekermann K, Pfirrmann M, Serve H, Stolzel F, Alakel N, Middeke JM, Thiede C, Ehninger G, Berdel WE, Stelljes M. Allogeneic Hematopoietic Cell Transplantation vs Standard Consolidation Chemotherapy in Patients With Intermediate-Risk Acute Myeloid Leukemia: A Randomized Clinical Trial. JAMA Oncol. 2023 Apr 1;9(4):519-526. doi: 10.1001/jamaoncol.2022.7605. PMID 36757706