Trial document




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  DRKS00004300

Trial Description

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Title

Reduced Relapse risk in patients with AML and NHL after HCMV-replication post haematopoietic stem cell transplantation

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Trial Acronym

[---]*

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URL of the Trial

http://keine

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Brief Summary in Lay Language

The detection of a cytomegalovirus (CMV) replication in patients after transplant was associated with a worse outcome of transplant up to date. But since the detection and therapy of CMV has improved markedly recently, the outcome of a CMV replication has improved, too and is no more associated with a worse outcome. Moreover, we have found that the occurrence of a CMV replication is associated with a reduced relapse risk of leukemia after transplant. Here we aimed to investigate in a new prospective study if a HCMV replication in patients with acute leukemia or lymphoma also shows an anti-tumor effect by reducing the relapse risk or progression of disease after allogeneic transplant and improves the outcome.

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Brief Summary in Scientific Language

The detection of HCMV replication in patients with AML or NHL has been associated with a reduced relapse risk or progression of disease after allogeneic transplant and have therefore improved outcome of transplant in retrospective analysed studies. In the light of these data and given the unmet medical need to reduce the rate of relapse of AML or relapse or progression of NHL after alloSCT, there is a rationale to examine in a prospective study the efficacy of an HCMV replication after alloSCT on these endpoints.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00004300
  •   2012/08/07
  •   [---]*
  •   yes
  •   Approved
  •   12-5086-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

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

  •   C92 -  Myeloid leukaemia
  •   C85 -  Other and unspecified types of non-Hodgkin's lymphoma
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Interventions/Observational Groups

  •   patients with NHL or AML in whom a CMV replication is documented after transplant
  •   Patients with AML or NHL in whom a CMV replication is not documented after transplant
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prognosis
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

relapse rate, disease free survival at 24 months post transplant

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Secondary Outcome

overall survival, incidence of GVHD, none-relapse-mortality at 24 months post transplant

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2012/08/15
  •   200
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• Patient's informed consent
• No application of prophylactic ganciclovir or other CMV specific drugs or immunoglobuline preparations in the entire posttransplant course
• regular at least once weekly monitoring of CMV pp65-antigenemia or CMV copy by PCR until day 120 after

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Exclusion Criteria

• Relapsed or progressive malignant disease (other than minimal residual disease diagnosed by molecular methods) within 90 days after transplant
• Severe uncontrolled infections

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Addresses

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    • Uniklinik Essen, Klinik für KMT
    • Mr.  Prof. Dr. med  Ahmet  Elmaagacli 
    • Hufelandstr
    • 45147  Essen
    • Germany
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    • Klinik für KMT Uniklinik Essen
    • Mr.  Prof. Dr.  Ahmet  Elmaagacli 
    • Hufelandstr.55
    • 45147  Essen
    • Germany
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    • Uniklinik Essen Klinik für KMT
    • Mr.  Prof. Dr.  Ahmet  Elmaagacli 
    • Hufelandstr.55
    • 45147  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik Essen
    • Mr.  Prof Dr  Ahmet  Elmaagacli 
    • Hufelandstr 55
    • 45147  Esseb
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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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.