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

Acute Myeloid Leukemia Clinical Trial

— FLAT-Auto  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03961919
• Other study ID #: 2008-000664-16
• Status: Completed
• Phase: Phase 2
• Start date: February 10, 2009
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2023
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Hematologic Neoplasms
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Preleukemia
• Transplant-Related Hematologic Malignancy

Intervention

Drug:
• Fludarabine
Fludarabine i.v. 30 mg/m²/d day -6 to -2
• ARA-C
Cytarabine i.v. 2 g/m²/d day -6 to -2
• Treosulfan
Treosulfan i.v. 10 g/m²/d day -6 to -4

Procedure:
• Peripheral Blood Stem Cell Transplant
Autologous stem-cell transplantation i.v.: day 0 (source: peripheral blood) Pegylated-Filgrastim s.c. 6 mg day +3

Locations

Country	Name	City	State
Italy	Ospedale San Raffaele	Milano	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
Ciceri Fabio

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of disease free survival from first Complete Remission (CR)	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).	2 years after transplantation