Status:
TERMINATED
Central Nervous System (CNS) Involvement in Acute Myeloid Leukemia (AML)
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Brief Summary
The present study aims at evaluating the prognostic factors at diagnosis predicting Central Nervous System (CNS) relapse in order to identify a group of patients with higher risk of CNS involvement in...
Detailed Description
CNS involvement in AML is a rare event, poorly detailed in literature. Few data are available in pediatric cases, and less frequent in adult cases. Predisposing factors for AML adult patients with CNS...
Eligibility Criteria
Inclusion
- Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable).
- Patients aged ≥18 years affected by AML according to the FAB criteria, previously enrolled in GIMEMA Studies for AML treatment. AML patients with CNS involvement defined by the confirmation of leukemic blast cells in the centrifuged cerebrospinal fluid (CSF) with the presence of more than five WBCs in the CSF or the detection of a CNS granulocytic sarcoma using computed tomography or magnetic resonance imaging.
Exclusion
- Patients with acute promyelocytic leukemia (FAB M3 subtype), antecedent haematological diseases or therapy-related AML.
Key Trial Info
Start Date :
March 19 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 5 2020
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03410407
Start Date
March 19 2019
End Date
June 5 2020
Last Update
October 26 2022
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia
Alessandria, Italy
2
Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica
Ancona, Italy
3
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
Bari, Italy
4
Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo
Cagliari, Italy