Phase II Trial in Elderly Patients With AML or MDS in Complete Remission Not Eligible for Allogenic Transplant (FLAT-Auto)

Ciceri Fabio

Status and phase

Completed

Phase 2

Conditions

Transplant-Related Hematologic Malignancy

Myelodysplastic Syndromes

Acute Myeloid Leukemia

Treatments

Drug: ARA-C

Procedure: Peripheral Blood Stem Cell Transplant

Drug: Fludarabine

Drug: Treosulfan

Study type

Interventional

Funder types

Other

Identifiers

NCT03961919

2008-000664-16

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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