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出境医 / 临床实验 / Phase II Trial in Elderly Patients With AML or MDS in Complete Remission Not Eligible for Allogenic Transplant (FLAT-Auto)

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

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Myelodysplastic Syndromes Transplant-Related Hematologic Malignancy Drug: Fludarabine Drug: ARA-C Drug: Treosulfan Procedure: Peripheral Blood Stem Cell Transplant Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : February 10, 2009
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: FLAT-Auto
Treosulfan in a combination regimen with ARA-C and fludarabine as conditioning therapy prior to autologous PBSCT
 Drug: Fludarabine
Fludarabine i.v. 30 mg/m²/d day -6 to -2

Drug: ARA-C
Cytarabine i.v. 2 g/m²/d day -6 to -2

Drug: 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
Outcome Measures
Primary Outcome Measures :
  1. Evaluation of disease free survival from first Complete Remission (CR) [ Time Frame: 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).


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
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Italy
Ospedale San Raffaele
Milano, Lombardia, Italy, 20132
Sponsors and Collaborators
Ciceri Fabio
Tracking Information
First Submitted Date  ICMJE May 22, 2019
First Posted Date  ICMJE May 23, 2019
Last Update Posted Date July 12, 2019
Actual Study Start Date  ICMJE February 10, 2009
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2019) 		Evaluation of disease free survival from first Complete Remission (CR) [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2019) 		Evaluation of disease free survival from first CR [ Time Frame: 2 years after transplantation ]
evaluation of DFS duration from documented first CR of AML or MDS with intermediate 2 or high IPSS.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Trial in Elderly Patients With AML or MDS in Complete Remission Not Eligible for Allogenic Transplant
Official Title  ICMJE 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)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndromes
  • Transplant-Related Hematologic Malignancy
Intervention  ICMJE
  • Drug: Fludarabine
    Fludarabine i.v. 30 mg/m²/d day -6 to -2
  • Drug: ARA-C
    Cytarabine i.v. 2 g/m²/d day -6 to -2
  • Drug: 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
Study Arms  ICMJE Experimental: FLAT-Auto
Treosulfan in a combination regimen with ARA-C and fludarabine as conditioning therapy prior to autologous PBSCT
Interventions:
  • Drug: Fludarabine
  • Drug: ARA-C
  • Drug: Treosulfan
  • Procedure: Peripheral Blood Stem Cell Transplant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 22, 2019) 		15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03961919
Other Study ID Numbers  ICMJE 2008-000664-16
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ciceri Fabio, IRCCS San Raffaele
Study Sponsor  ICMJE Ciceri Fabio
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account IRCCS San Raffaele
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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