Acute Myeloid LeukemiaPhase 2FLAT-AutoNCT03961919
Phase II Trial in Elderly Patients With AML or MDS in Complete Remission Not Eligible for Allogenic Transplant
A Phase 2 study testing Fludarabine, ARA-C and Treosulfan in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Ciceri Fabio at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndromes, Transplant-Related Hematologic Malignancy
- What is being tested?
- Fludarabine, ARA-C and Treosulfan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 10 Feb 2009to 31 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes, Transplant-Related Hematologic Malignancy
- Being tested
- Fludarabine, ARA-C, Treosulfan, Peripheral Blood Stem Cell Transplant
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
Fludarabine i.v. 30 mg/m²/d day -6 to -2
ARA-CDrug
Cytarabine i.v. 2 g/m²/d day -6 to -2
TreosulfanDrug
Treosulfan i.v. 10 g/m²/d day -6 to -4
Peripheral Blood Stem Cell TransplantProcedure or surgery
Autologous stem-cell transplantation i.v.: day 0 (source: peripheral blood)
Pegylated-Filgrastim s.c. 6 mg day +3
| Study group | Role | What they receive |
|---|---|---|
| FLAT-Auto | Experimental | Treosulfan in a combination regimen with ARA-C and fludarabine as conditioning therapy prior to autologous PBSCT Receives: Drug: Fludarabine; Drug: ARA-C; Drug: Treosulfan; Procedure: Peripheral Blood Stem Cell Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start10 Feb 2009
- Primary completion31 Dec 2019
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciceri Fabio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ciceri Fabio, IRCCS San Raffaele
- Investigators
- Fabio Ciceri, MD, Principal investigator, San Raffaele Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03961919
- Sponsor's protocol ID
- 2008-000664-16
- Other IDs
- 2008
- Acronym
- FLAT-Auto
- Status last verified
- Nov 2023
- First submitted
- 22 May 2019
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03961919
- Acronym / sponsor ID
- FLAT-Auto / 2008-000664-16
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes, Transplant-Related Hematologic Malignancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ciceri FabioUniversity, hospital or other
- Study start
- 10 Feb 2009 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLAT-Auto | Experimental | Drug: Fludarabine, Drug: ARA-C, Drug: Treosulfan, Procedure: Peripheral Blood Stem Cell TransplantTreosulfan in a combination regimen with ARA-C and fludarabine as conditioning therapy prior to autologous PBSCT |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FludarabineFludarabine i.v. 30 mg/m²/d day -6 to -2 | Drug | FLAT-Auto |
| ARA-CCytarabine i.v. 2 g/m²/d day -6 to -2 | Drug | FLAT-Auto |
| TreosulfanTreosulfan i.v. 10 g/m²/d day -6 to -4 | Drug | FLAT-Auto |
| Peripheral Blood Stem Cell TransplantAutologous stem-cell transplantation i.v.: day 0 (source: peripheral blood) Pegylated-Filgrastim s.c. 6 mg day +3 | Procedure or surgery | FLAT-Auto |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio Ciceri, MD principal investigator
San Raffaele Hospital IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fludarabine, ARA-C and Treosulfan in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Ciceri Fabio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of disease free survival from first Complete Remission (CR) (time frame: 2 years after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.