Trial document





This trial has been registered retrospectively.
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  DRKS00005719

Trial Description

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Title

Thiotepa in autologous stem cell transplantation (ASCT):
A non-interventional, prospective study to assess safety and efficacy of Thiotepa-based high dose chemotherapy (HDCT) prior to autologous stem cell transplantation in adults with B- or T-cell lymphoma (non-Hodgkin lymphoma or Hodgkin lymphoma) with or without CNS involvement or with primary CNS lymphoma.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Assessment of safety and efficacy of Thiotepa in high dose chemotherapy prior to autologous stem cell transplantation.
study population:
Patients with B- or T-cell lymphoma (non-Hodgkin lymphoma or Hodgkin lymphoma) with or without CNS involvement or with primary CNS lymphoma.
- age ≥ 18 years
- first autologous stem cell transplantation (ASCT)
- Thiotepa-based high dose chemotherapy prior to ASCT
therapy:
Thiotepa-based high dose chemotherapy prior to ASCT:
- Thiotepa + BCNU +/- Etoposid
- Thiotepa + Etoposid + AraC + Melphalan (TEAM)
- Thiotepa + other

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Brief Summary in Scientific Language

study population:
Patients with B- or T-cell lymphoma (non-Hodgkin lymphoma or Hodgkin lymphoma) with or without CNS involvement or with primary CNS lymphoma.
Primary inclusion criteria:
- signed informed consent form
- age ≥ 18 years
- patients with a documented B- or T-cell lymphoma (non-Hodgkin lymphoma or Hodgkin lymphoma) with or without CNS involvement or with primary CNS lymphoma
- first autologous stem cell transplantation (ASCT)
- Thiotepa-based high dose chemotherapy prior to ASCT
therapy:
Thiotepa-based high dose chemotherapy prior to ASCT:
- Thiotepa + BCNU +/- Etoposid
- Thiotepa + Etoposid + AraC + Melphalan (TEAM)
- Thiotepa + other

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Organizational Data

  •   DRKS00005719
  •   2014/02/24
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  •   no
  •   Approved
  •   3933-11/13, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

  •   082G 
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Health Condition or Problem studied

  •   B- or T-cell lymphoma (non-Hodgkin lymphoma or Hodgkin lymphoma) with or without CNS involvement or with primary CNS lymphoma
  •   C81 -  Hodgkin lymphoma
  •   C82 -  Follicular lymphoma
  •   C83 -  Non-follicular lymphoma
  •   C84 -  Mature T/NK-cell lymphomas
  •   C85 -  Other and unspecified types of non-Hodgkin lymphoma
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Interventions/Observational Groups

  •   - Thiotepa + BCNU +/- Etoposid
    - Thiotepa + Etoposid + AraC + Melphalan (TEAM)
    - Thiotepa + other
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IV
  •   No
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Primary Outcome

Therapy associated organ toxicity up to day 30 and day 100 after ASCT.

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Secondary Outcome

Safety criteria:

- occurrence of AEs from day 1 of high dose chemotherapy until day 100 after ASCT
- occurrence of ADRs and SAEs from day 1 of high dose chemotherapy until 1 year after ASCT
- duration of hospitalization
- Recovery A (1st day granulocytes ≥ 500/μL or 1st day leucocytes ≥ 1.000/μL) and Recovery B (1st day thrombocytes ≥ 20.000/μL)
- transplantation related mortality (TRM) at day 30 and day 100 after ASCT
- cumulative incidence of mortality without recurrence (NRM) 1 year after ASCT
Efficacy criteria:
- Overall response rate (ORR) at day 100 und after 1 year (CCR, CR, PR, SD, PD, Switchrate PR=>CR)
- progression free survival (PFS) 1 year after ASCT
- cumulative incidence of recurrence 1 year after ASCT
- overall survival (OS) 1 year after ASCT

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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

  •   Actual
  •   2013/12/04
  •   150
  •   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

- signed informed consent form
- age ≥ 18 years
- patients with a documented B- or T-cell lymphoma (non-Hodgkin lymphoma or Hodgkin lymphoma) with or without CNS involvement or with primary CNS lymphoma
- first autologous stem cell transplantation (ASCT)
- Thiotepa-based high dose chemotherapy prior to ASCT

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Exclusion Criteria

Contraindications:

Hypersensitivity to the active substance.
Pregnancy and lactation
Concomitant use with yellow fever vaccine and with live virus and bacterial vaccines

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Addresses

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    • RIEMSER Pharma GmbH
    • An der Wiek 7
    • 17493  Greifswald - Insel Riems
    • Germany
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    • RIEMSER Pharma GmbH
    • Ms.  Dr.  Janka  Schössow 
    • An der Wiek 7
    • 17493  Greifswald
    • Germany
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    • RIEMSER Pharma GmbH
    • Mr.  Dr.  Dietmar  Schröder 
    • An der Wiek 7
    • 17493  Greifswald
    • 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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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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