Trial document




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  DRKS00004581

Trial Description

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Title

ATG Fresenius observational study on the prevention of GvHD in allogeneic stem cell transplant patients

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Trial Acronym

ATOS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study will capture the use of ATG-Fresenius in day to day clinical practice and investigate the patients’ benefit resulting from GvHD (Graft versus host disease) prophylaxis with ATG-Fresenius in the context of stem cell transplantation (SCT).

Patients designated to undergo allogeneic bone marrow or peripheral
blood stem cell transplantation from matched unrelated donors who will
receive GvHD prevention according to ATG-Fresenius S could be enrolled.

Enrolled patients will be evaluated and treated according to summary of
Product Characteristics (SPC-Fachinformation) and physicians’ decision.

Patients data will be collected related to:

Quality of life (questionnaire)
GvHD related endpoints (eg survival)

Effects of ATG-Fresenius S with regard to
terms of safety and tolerability, freedom from GvHD, freedom from relapse, survival, and quality of life will be analysed.

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Brief Summary in Scientific Language

This study will capture the use of ATG-Fresenius in day to day clinical practice and investigate the patients’ benefit resulting from GvHD prophylaxis with ATG-Fresenius in the context of allogeneic hematopoietic stem cell transplantation (SCT), in terms of safety and tolerability, freedom from GvHD, freedom from relapse, survival, and quality of life.

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Organizational Data

  •   DRKS00004581
  •   2013/01/17
  •   [---]*
  •   no
  •   Approved
  •   503/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   10018651: GVHD
  •   T86.01 -  [generalization T86.0: Bone-marrow transplant rejection]
  •   T86.02 -  [generalization T86.0: Bone-marrow transplant rejection]
  •   T86.03 -  [generalization T86.0: Bone-marrow transplant rejection]
  •   T86.04 -  [generalization T86.0: Bone-marrow transplant rejection]
  •   T86.09 -  [generalization T86.0: Bone-marrow transplant rejection]
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Interventions/Observational Groups

  •   Adult Patients with haematological malignancies receiving stem cell transplantation from matched unrelated donors which are in therapy for prevention of graft-versus-host disease (GvHD) in combination with standard Cyclosporine A (CyA) / Methotrexate prophylaxis.

    Quality of life and medical data will be collected.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

GvHD and relapse- free survival, defined as survival free of severe GvHD and free of relapse within 12 months

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Secondary Outcome

• Engraftment until months 12
• aGvHD (acute GvHD) until months 12
• cGvHD (chronic GvHD) until months 12
• Relapse until months 12
• Relapse mortality until months 12
• Non-relapse mortality until months 12
• Disease-free survival until months 12
• Overall survival until months 12
• New malignancies until months 12
• Immunosuppressive therapy until months 12
• Quality-of-life (EQ-5d questionnaire at day 100 and months 12)
• Resource consumption until months 12
• Safety: Adverse Drug reactions (ADR), serious ADR (SADR), severe infections until months 12

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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

  •   Actual
  •   2013/05/17
  •   150
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

• Written informed consent
• Patients suffering from hematological malignancies
• Patients designated to undergo allogeneic bone marrow or peripheral blood stem cell transplantation from matched unrelated donors who will receive GvHD prevention according to ATG-F SPC
• Physician’s therapy decision is independent from inclusion

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Exclusion Criteria

• Patients who formerly underwent transplantation including previous autologous transplantation

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Neovii Biotech GmbH
    • Ms.  Dr.   Elisabeth  Schulze 
    • Am Haag 6+7
    • 82166  Gräfelfing
    • 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
    • Mr.  Ralf  Tostmann 
    • Elsässer Str. 2
    • 79110  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Neovii Biotech GmbH
    • Ms.  Elisabeth  Schulze 
    • Am Haag 6+7
    • 82166  Gräfelfing
    • 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.