NCT03961919

Phase II Trial in Elderly Patients With AML or MDS in Complete Remission Not Eligible for Allogenic Transplant

Evaluation of Safety and Efficacy of Treosulfan-cytarabine-fludarabine (FLAT) Combination Prior to Autologous Stem Cell Transplant (HSCT) in Elderly Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Ciceri Fabio · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

FLAT-Auto is a phase II trial. fludarabine and ARA-C will be combined with the alkylating agent treosulfan (FLAT), to investigate the feasibility and the efficacy of a new regimen, supported with autologous peripheral blood SCT (PBSCT), as final postremission consolidation in AML/MDS elderly patients.

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndromes
• Transplant-Related Hematologic Malignancy

Interventions

Type	Name	Description
DRUG	Fludarabine	Fludarabine i.v. 30 mg/m²/d day -6 to -2
DRUG	ARA-C	Cytarabine i.v. 2 g/m²/d day -6 to -2
DRUG	Treosulfan	Treosulfan i.v. 10 g/m²/d day -6 to -4
PROCEDURE	Peripheral Blood Stem Cell Transplant	Autologous stem-cell transplantation i.v.: day 0 (source: peripheral blood) Pegylated-Filgrastim s.c. 6 mg day +3

Timeline

• Start date: 2009-02-10
• Primary completion: 2019-12-31
• Completion: 2021-12-31
• First posted: 2019-05-23
• Last updated: 2023-11-18

Locations

1 site across 1 country: Italy