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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03961919

Acronym

FLAT-Auto

Enrollment

Registered

2019-05-23

Start date

2009-02-10

Completion date

2021-12-31

Last updated

2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

DRUGFludarabine

Fludarabine i.v. 30 mg/m²/d day -6 to -2

DRUGARA-C

Cytarabine i.v. 2 g/m²/d day -6 to -2

DRUGTreosulfan

Treosulfan i.v. 10 g/m²/d day -6 to -4

PROCEDUREPeripheral Blood Stem Cell Transplant

Autologous stem-cell transplantation i.v.: day 0 (source: peripheral blood) Pegylated-Filgrastim s.c. 6 mg day +3

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

* Pts with de novo or secondary AML or with Int 2 or High risk MDS according to IPSS. * Pts unable or unfit to receive SCT from an HLA (human leukocyte antigen)-identical related (SIB) or unrelated (MUD), or HLA-haploidentical related (HAPLO) donor. * Hematologic CR (Appendix D) after 1 or 2 cycles of induction standard chemotherapy. * Successful collection of autologous PBSC: ≥ 5.0x10e6 /kg patient bodyweight (BW) * Age ≥ 65 years. * Performance status 0-2 ECOG (Eastern Cooperative Oncology Group), 60-100% Karnofsky (Appendix E). * Written informed consent.

Exclusion criteria

* Diagnosis of AML M3. * Second concomitant malignancies. * Severe concomitant illnesses/medical conditions (e.g. impaired respiratory and/or cardiac function). * Known and manifested malignant involvement of the central nervous system (CNS) * Active infectious disease * HIV- positivity or active hepatitis infection * Impaired liver function (bilirubin \> 1.5 x upper normal limit; transaminases \> 3.0 x upper normal limit) * Impaired renal function (creatinine-clearance \< 60 ml/min; serum creatinine \> 1.5 x upper normal limit). * Known hypersensitivity to treosulfan and/or cytarabine and/or fludarabine * Participation in another experimental drug trial within 4 weeks before day -6 * Non-cooperative behaviour or non-compliance * Psychiatric diseases or conditions that might impair the ability to give informed consent

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of disease free survival from first Complete Remission (CR)	2 years after transplantation	Evaluation of disease-free survival (DFS) duration from documented first CR of AML or MDS with intermediate 2 or high IPSS (International Prognostic Score System).

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026