Clinical trial · Interventional
Up-front Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia Patients Aged 65-75
Up-front Hematopoietic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia Aged 65-75
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients with acute myeloid leukemia aged 65-75 have a very poor prognosis, irrespective of the treatment strategy, including demethylating agents or conventional chemotherapy. With these approaches, remission rates do not exceed 40%, and overall disease-free survival at 1 year is in the order of 15%. The hypothesis is that up-front allogeneic hematopoietic stem cell transplant will produce a complete remission rate of 60% on day +56-70, and disease-free survival at 1 year of 30%. This is a single arm phase II study of upfront allogeneic stem cell transplantation, for patients with acute myeloid leukemia aged 65-75: the primary endpoint is a complete remission rate on day +56-70. The secondary endpoint is a 1-year overall disease-free survival of 30%.
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, Adult | Adult Acute Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Up-front allogeneic hematopoietic stem cell transplantation (HSCT) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Allogeneic hematopoietic stem cell transplantation
- description
- Day -6, -5 Thiotepa 5 mg/kg/day . Day -4 to -3 Busulfan i. v 3,2 mg/kg/day and fludarabine i.v. 50 mg/m2 /day Day -2 fludarabine i.v. 50 mg/m2 Day -1 Rest Day 0 Begin cyclosporine; Infusion of T cell replete bone marrow transplant Day 1 Begin mycophenolate mofetil Day 3 and 5 Cyclophosphamide 50 mg/kg IV and Mesna Day 6 G-colony stimulating factor
- interventionNames
- Drug: Up-front allogeneic hematopoietic stem cell transplantation (HSCT)
Primary outcomes (1)
- measure
- Rate of complete remission equal or higher than 60%
- timeFrame
- From day 56 to day +70 post-transplant
- description
- As a primary outcome measure, the rate of complete remission in treated patients will be evaluated. Complete remission will be assessed from days +56 to days +70 after transplant. A complete remission rate equal to or higher than 60% is expected.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 65-75 * Patients with de novo or secondary acute myeloid leukemia (AML) - intermediate or high risk according to European LeukemiaNet (ELN) recommendations 2017 * Untreated patients at diagnosis of acute myeloid leukemia - patients may have received treatment for high-risk myelodysplastic syndromes with hypomethylating agents (HMA). They should not have received a course of induction chemotherapy to be eligible for this study * Haploidentical family stem cell donor or other suitable donors available * Fit and unfit patients by geriatric scale assessment * Signed informed consent. Exclusion Criteria: * Acute Myeloid Leukemia good risk according to European LeukemiaNet 2017 * Positive serology for Human Immunodeficiency Virus. * Serious organ dysfunction: left ventricular ejection fraction \< 40%, forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and diffusing capacity of the lung for carbon monoxide (DLCO) \<50% of predicted, Liver Function Tests \> 5 x the upper limit of normal, or creatinine clearance \<30 ml/min . * Life expectancy less than 30 days. * Frail patients by geriatric scale assessment
References
Publications (0)
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