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

Phase 2

Completed

• Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndromes; Transplant-Related Hematologic Malignancy
• Interventions: Drug: Fludarabine; Drug: ARA-C; Drug: Treosulfan; Procedure: Peripheral Blood Stem Cell Transplant

• Registration Number: NCT03961919
• Lead Sponsor: Ciceri Fabio

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-10
• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-05-22
• Study First Posted: 2019-05-23
• Primary Completion: 2019-12-31
• Study Completion: 2021-12-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-17
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FLAT-Auto	Peripheral Blood Stem Cell Transplant	Treosulfan in a combination regimen with ARA-C and fludarabine as conditioning therapy prior to autologous PBSCT
FLAT-Auto	Fludarabine	Treosulfan in a combination regimen with ARA-C and fludarabine as conditioning therapy prior to autologous PBSCT
FLAT-Auto	Treosulfan	Treosulfan in a combination regimen with ARA-C and fludarabine as conditioning therapy prior to autologous PBSCT
FLAT-Auto	ARA-C	Treosulfan in a combination regimen with ARA-C and fludarabine as conditioning therapy prior to autologous PBSCT

Primary Outcome Measures

Name	Time	Method
Evaluation of disease free survival from first Complete Remission (CR)	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).

Trial Locations

Locations (1)

Ospedale San Raffaele; 🇮🇹 Milano, Lombardia, Italy