- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03961919
Phase II Trial in Elderly Patients With AML or MDS in Complete Remission Not Eligible for Allogenic Transplant (FLAT-Auto)
November 17, 2023 updated by: Ciceri Fabio
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Lombardia
-
Milano, Lombardia, Italy, 20132
- Ospedale San Raffaele
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FLAT-Auto
Treosulfan in a combination regimen with ARA-C and fludarabine as conditioning therapy prior to autologous PBSCT
|
Fludarabine i.v.
30 mg/m²/d day -6 to -2
Cytarabine i.v. 2 g/m²/d day -6 to -2
Treosulfan i.v. 10 g/m²/d day -6 to -4
Autologous stem-cell transplantation i.v.: day 0 (source: peripheral blood) Pegylated-Filgrastim s.c. 6 mg day +3 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of disease free survival from first Complete Remission (CR)
Time Frame: 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).
|
2 years after transplantation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fabio Ciceri, MD, San Raffaele Hospital IRCCS
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 10, 2009
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
May 22, 2019
First Submitted That Met QC Criteria
May 22, 2019
First Posted (Actual)
May 23, 2019
Study Record Updates
Last Update Posted (Actual)
November 18, 2023
Last Update Submitted That Met QC Criteria
November 17, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Bone Marrow Diseases
- Hematologic Diseases
- Precancerous Conditions
- Myelodysplastic Syndromes
- Hematologic Neoplasms
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Preleukemia
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Fludarabine
- Treosulfan
Other Study ID Numbers
- 2008-000664-16
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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