NCT03902665CompletedPhase 2
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 · Last updated 23 Jul 2024
Brief summary (registry, in English)
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%.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 19 (actual)
- First submitted
- 2 Apr 2019
- Start date
- 15 Mar 2019
- Primary completion date
- 31 Mar 2024
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT03902665
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 19
- From 15 Mar 2019 to the primary completion date, 31 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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 .
Other
- Acute Myeloid Leukemia good risk according to European LeukemiaNet 2017
- Positive serology for Human Immunodeficiency Virus.
- Life expectancy less than 30 days.
- Frail patients by geriatric scale assessment
Who the study is looking for
- 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.
Age in the registry: 65 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.