Up-front Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia Patients Aged 65-75

• Status: Unknown status
• Trial end date: 2021-03-30
• Target enrollment: 0
• Participant gender: All

Summary

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%.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Policlinico Universitario Agostino Gemelli
• Collaborator: Associazione Italiana per la Ricerca sul Cancro

Criteria

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