Clinical trial · Interventional
Phase II Trial in Elderly Patients With AML or MDS in Complete Remission Not Eligible for Allogenic Transplant
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Transplant-Related Hematologic Malignancy | Transplant-Related Hematologic Malignancy | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ARA-C | Drug | Cytarabine | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Peripheral Blood Stem Cell Transplant | Procedure | — | UNRESOLVED |
| Treosulfan | Drug | Treosulfan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FLAT-Auto
- description
- Treosulfan in a combination regimen with ARA-C and fludarabine as conditioning therapy prior to autologous PBSCT
- interventionNames
- Drug: Fludarabine
- Drug: ARA-C
- Drug: Treosulfan
- Procedure: Peripheral Blood Stem Cell Transplant
Primary outcomes (1)
- measure
- Evaluation of disease free survival from first Complete Remission (CR)
- timeFrame
- 2 years after transplantation
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available