Clinical trial · Interventional
HCT Versus CT in Elderly AML
Randomized Phase III Study Comparing Conventional Chemotherapy to Low Dose Total Body Irradiation-Based Conditioning and HCT From Related and Unrelated Donors as Consolidation Therapy for Older Patients With AML in 1st Complete Remission
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recommendation of DMC
Summary
Brief summary (as posted)
A study comparing conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors as consolidation therapy for older Patients with AML in first Complete Remission.
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 |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hematopoietic cell transplantation | Procedure | — | UNRESOLVED |
| Non-Transplant treatment approach for consolidation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Transplant Arm
- description
- Hematopoietic cell transplantation after Reduced Intensity Conditioning
- interventionNames
- Procedure: hematopoietic cell transplantation
- type
- ACTIVE_COMPARATOR
- label
- Conventional Chemotherapy
- description
- The non-transplant treatment approach for consolidation
- interventionNames
- Drug: Non-Transplant treatment approach for consolidation
Primary outcomes (1)
- measure
- To evaluate Leukaemia Free Survival (LFS) after allo HCT in AML/RAEB in complete remission using matched or unrelated donors in comparison to conventional chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 60years and ≤ 75 years * primary or secondary AML as defined by WHO or refractory anemia with excess of blasts (RAEB) * First complete remission following one or two cycles of induction chemotherapy * Chemotherapy was administered according to current participating cooperative group protocols * Karnofsky score ≥ 70 * Written informed consent Exclusion Criteria: * AML FAB M3 * HIV positivity * Participation in another clinical trial without prior consent of the coordinating investigator, patients may exceptionally take part in a further study only if * The second study exclusively concerns induction therapy * Consolidation cycle one and two are given according to the accredited study group policy * No investigational drugs are used post registration for the HCT vs CT in eldery AML study. * Documentation for the HCT vs CT in eldery AML study is not compromised. Second hand data from foreign study is not accepted
References
Publications (0)
Data not yet available