Phase II Trial in Elderly Patients With AML or MDS in Complete Remission Not Eligible for Allogenic Transplant

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ciceri Fabio
• Treatments: Busulfan; Cytarabine; Fludarabine; Fludarabine phosphate; Treosulfan; Vidarabine

Criteria

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