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

NCT03961919 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-11-18

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Ciceri Fabio

    lead OTHER

Principal Investigators

  • Fabio Ciceri, MD · San Raffaele Hospital IRCCS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-10
Primary Completion
2019-12-31
Completion
2021-12-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03961919 on ClinicalTrials.gov