Phase II Trial in Elderly Patients With AML or MDS in Complete Remission Not Eligible for Allogen… (NCT03961919) | Clinical Trial Compass
CompletedPhase 2
Phase II Trial in Elderly Patients With AML or MDS in Complete Remission Not Eligible for Allogenic Transplant
Italy15 participantsStarted 2009-02-10
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of disease free survival from first Complete Remission (CR)