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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-10

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Myeloid Leukemia Myelodysplastic Syndromes Transplant-Related Hematologic Malignancy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FLAT-Auto

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

Group Type EXPERIMENTAL

Fludarabine

Intervention Type DRUG

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

ARA-C

Intervention Type DRUG

Cytarabine i.v. 2 g/m²/d day -6 to -2

Treosulfan

Intervention Type DRUG

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

Peripheral Blood Stem Cell Transplant

Intervention Type PROCEDURE

Autologous stem-cell transplantation i.v.: day 0 (source: peripheral blood)

Pegylated-Filgrastim s.c. 6 mg day +3

Interventions

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Fludarabine

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

Intervention Type DRUG

ARA-C

Cytarabine i.v. 2 g/m²/d day -6 to -2

Intervention Type DRUG

Treosulfan

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

Intervention Type DRUG

Peripheral Blood Stem Cell Transplant

Autologous stem-cell transplantation i.v.: day 0 (source: peripheral blood)

Pegylated-Filgrastim s.c. 6 mg day +3

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No