NCT03961919

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2009

Completed
10.3 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 23, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

10.9 years

First QC Date

May 22, 2019

Last Update Submit

November 17, 2023

Conditions

Acute Myeloid LeukemiaMyelodysplastic SyndromesTransplant-Related Hematologic Malignancy

Outcome Measures

Primary Outcomes (1)

  • Evaluation of disease free survival from first Complete Remission (CR)

    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).

    2 years after transplantation

Study Arms (1)

FLAT-Auto

EXPERIMENTAL

Treosulfan in a combination regimen with ARA-C and fludarabine as conditioning therapy prior to autologous PBSCT

Drug: FludarabineDrug: ARA-CDrug: TreosulfanProcedure: Peripheral Blood Stem Cell Transplant

Interventions

FludarabineDRUG

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

FLAT-Auto
ARA-CDRUG

Cytarabine i.v. 2 g/m²/d day -6 to -2

FLAT-Auto
TreosulfanDRUG

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

FLAT-Auto
Peripheral Blood Stem Cell TransplantPROCEDURE

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

FLAT-Auto

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

Location

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic Syndromes

Interventions

fludarabineCytarabinetreosulfanPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Fabio Ciceri, MD

    San Raffaele Hospital IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Hematology and Translplant Unit

Study Record Dates

First Submitted

May 22, 2019

First Posted

May 23, 2019

Study Start

February 10, 2009

Primary Completion

December 31, 2019

Study Completion

December 31, 2021

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations

IT(1)