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

Primary Purpose

Acute Myeloid Leukemia, Myelodysplastic Syndromes, Transplant-Related Hematologic Malignancy

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Fludarabine

ARA-C

Treosulfan

Peripheral Blood Stem Cell Transplant

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

Ospedale San Raffaele

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FLAT-Auto

Arm Description

Treosulfan in a combination regimen with ARA-C and fludarabine as conditioning therapy prior to autologous PBSCT

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT03961919

First Posted

May 22, 2019

Last Updated

July 18, 2022

Sponsor

Ciceri Fabio

1. Study Identification

Unique Protocol Identification Number

NCT03961919

Brief Title

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

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

February 10, 2009 (Actual)

Primary Completion Date

December 31, 2019 (Actual)

Study Completion Date

December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Ciceri Fabio

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia, Myelodysplastic Syndromes, Transplant-Related Hematologic Malignancy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FLAT-Auto

Arm Type

Experimental

Arm Description

Treosulfan in a combination regimen with ARA-C and fludarabine as conditioning therapy prior to autologous PBSCT

Intervention Type

Drug

Intervention Name(s)

Fludarabine

Intervention Description

Fludarabine i.v. 30 mg/m²/d day -6 to -2

Intervention Type

Drug

Intervention Name(s)

ARA-C

Intervention Description

Cytarabine i.v. 2 g/m²/d day -6 to -2

Intervention Type

Drug

Intervention Name(s)

Treosulfan

Intervention Description

Treosulfan i.v. 10 g/m²/d day -6 to -4

Intervention Type

Procedure

Intervention Name(s)

Peripheral Blood Stem Cell Transplant

Intervention Description

Autologous stem-cell transplantation i.v.: day 0 (source: peripheral blood) Pegylated-Filgrastim s.c. 6 mg day +3

Primary Outcome Measure Information:

Title

Evaluation of disease free survival from first Complete Remission (CR)

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).

Time Frame

2 years after transplantation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Ospedale San Raffaele

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20132

Country

Italy

12. IPD Sharing Statement

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

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