Trial document




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  DRKS00005126

Trial Description

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Title

Thiotepa- Fludarabine- Treosulfan (TFT) conditioning for 2nd allogeneic PBSCT
from unrelated donors in patients with AML relapsing from prior allogeneic
HSCT

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Trial Acronym

TFT 2 Tx

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URL of the Trial

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Brief Summary in Lay Language

Main purpose of the study is to assess the probability of disease-free survival, defined as being alive and free of relapse at 1 year after 2nd allogeneic PBSCT from unrelated donors after a reduced intensity conditioning with the chemotherapeutic agents Thiotepa, Fludarabine and Treosulfan and defined GvHD prophylaxis . So far, no standard conditioning for this clinical situation has been established. Study participants are patients aged 18 - 65 years with relapse in leukemia after allogeneic HSCT. Aim of the current trial is to decrease the relapse rate below 40% and the non-relapse mortality below 20% at 1 year.

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Brief Summary in Scientific Language

Main purpose of the study is to test a specific dose combination of the three agents Thiotepa, Fludarabine and Treosulfan in 2nd allogeneic PBSCT for patients with relapse of AML s/t-AML after 1st allogeneic PBSCT. Aim of the current trial is to decrease the relapse rate below 40% and the non-relapse mortality below 20% at 1 year (leading to a disease free survival rate above 40% at 1 year) after 2nd allogeneic HSCT from unrelated donors after a uniform "intensive-RIC" conditioning with thiotepa, fludarabin and treosulfan and GvHD prophylaxis with cyclosporine, MPA and ATG-F.

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Organizational Data

  •   DRKS00005126
  •   2014/03/31
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  •   yes
  •   Approved
  •   426/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   2012-005414-18 
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Health Condition or Problem studied

  •   C92.0 -  Acute myeloblastic leukaemia [AML]
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Interventions/Observational Groups

  •   single-arm study, conditioning with Thiotepa, Fludarabine and Treosulfan
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
  •   Yes
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Primary Outcome

To assess the probability of disease-free survival, defined as being alive and free of relapse at 1 year after 2nd allogeneic PBSCT from unrelated donors after a uniform "intensive-RIC" conditioning with the TFT regimen and defined GvHD prophylaxis

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Secondary Outcome

•To assess the probability of disease-free survival (DFS) over time
•To assess the probability of relapse and non-relapse mortality over time
•To assess the probability of overall survival (OS) over time
•To assess the probability and severity of acute and chronic GvHD over time
•To assess the safety of the regimen

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/03/26
  •   50
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

1.Written informed consent obtained according to international guidelines and local laws;
2.Male of female patients aged 18-65 years;
3.Patients with AML including secondary and therapy-related AML;
4.Patients with hematological relapse > 6 months after prior allogeneic HSCT;
5.Patients designated to undergo second PBSCT from unrelated donor different from the previous donor;
6.Patients with a HLA-A, -B, -C and HLA-DRB1 matched (6 out of 8 alleles; high DNA-based resolution) unrelated donor;
7.ECOG performance status of ≤ 2 at study entry;
8.Ability to understand the nature of the trial and the trial related procedures and to comply with them;

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Exclusion Criteria

1.Patients with congestive heart failure NYHA Class III and IV, cardiac arrhythmias (except atrioventricular block type I and II, atrial fibrillation/flutter, bundle brunch block) or other signs and symptoms of relevant cardiovascular disease;
2.Known HIV infection, infectious hepatitis (type A, B or C) or another uncontrolled infection;
3.Known hypersensitivity to the active substances or any of the excipients;
4.Renally impaired patients with creatinine clearance < 30 ml/min (Cockcroft-Gault Equation);
5.Decompensated haemolytic anaemia;
6.Any condition, including laboratory abnormalities, which places the subject at unacceptable risk in the study or confounds the ability to interpret data from the study;
7.Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed;
8.Participation in a clinical trial within the last 30 days before the start of this trial (except for registry and diagnostic trials);
9.Known or persistent abuse of medication, drugs or alcohol;
10.Female patients who are pregnant or breast feeding;
11.Fertile patients refusing to use safe contraceptive methods during the study (for details see clinical trial protocol section 4.3);

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg
    • Mr.  Prof. Dr med.  Jürgen  Finke 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg
    • Ms.  Irmgard  Matt 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Riemser Pharma GmbH
    • An der Wiek 7
    • 17493  Greifswald – Insel Riems
    • Germany
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    • Neovii Biotech GmbH
    • Am Haag 6+7
    • 82166  Gräfeling
    • Germany
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    • Medac Gesellschaft für klinische Spezialpräparate mbH
    • Theaterstraße 6
    • 22880  Wedel
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.