Trial document





This trial has been registered retrospectively.
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  DRKS00009037

Trial Description

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Title

High-dose chemotherapy and autologous stem cell transplantation in elderly primary CNS lymphoma patients - retrospective chart review

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Trial Acronym

HDT-ASCT in elderly PCNSL

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URL of the Trial

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Brief Summary in Lay Language

Primary central nervous system lymphoma (PCNSL) is an aggressive Non-Hodgkin Lymphoma, which exclusively invades the central nervous system compartment at diagnosis. It accounts for 3% to 4% of all primary brain tumors and 4% to 6% of extra-nodal lymphomas. The incidence of PCNSL in immunocompetent patients has been steadily increasing over the last 30 years. Despite treatment improvement, the prognosis of PCNSL patients is still poor compared to systemic Non-Hodgkin Lymphoma. Patients older than 60 years account for 50% of all PCNSL cases. Although elderly patients are able to tolerate aggressive chemotherapy, they have an inferior prognosis compared to younger patients and are more seriously affected by iatrogenic toxicity; therefore they represent a unique treatment subgroup. High-dose chemotherapy followed by autologous stem cell transplantation has been shown to be feasible and highly effective in newly diagnosed eligible patients, but also in the salvage situation. Usually, this aggressive treatment approach is only offered to patients younger than 65 years of age. However, age alone may not be the only criterion to select patients for this effective treatment approach. In the present study, we plan to summarize feasibility, safety, and outcome of HCT-ASCT followed by ASCT in elderly PCNSL patients (> 65 years) treated at four different centers (Germany and United Kingdom) experienced in treating PCNSL patients.

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Brief Summary in Scientific Language

Primary central nervous system lymphoma (PCNSL) is an aggressive Non-Hodgkin Lymphoma mostly of B-cell origin, which exclusively invades the central nervous system compartment at diagnosis. It accounts for 3% to 4% of all primary brain tumors and 4% to 6% of extra-nodal lymphomas. The incidence of PCNSL in immunocompetent patients has been steadily increasing over the last 30 years. High-dose methotrexate (HD-MTX) in combination with HD-cytarabine (HD-AraC) is the backbone of current treatment. A recent randomized controlled trial investigated the role of whole brain radiotherapy (WBRT) as consolidation therapy compared to no consolidation therapy, suggesting that WBRT does not prolong survival but enhances disease control. However, despite treatment improvement, the prognosis of PCNSL patients is still poor compared to systemic Non-Hodgkin Lymphoma. Patients older than 60 years account for 50% of all PCNSL cases. Although elderly patients are able to tolerate aggressive systemic chemotherapy, they have an inferior prognosis compared to younger patients and are more seriously affected by iatrogenic toxicity, especially neurotoxicity following WBRT; therefore they represent a unique treatment subgroup. An US registry study of 579 elderly patients diagnosed with PCNSL in the 1990s revealed that the median survival was only 7 months and WBRT alone was the most common treatment modality (46%). High-dose chemotherapy with carmustine (BCNU) and thiotepa followed by autologous stem cell transplantation (ASCT) has been shown to be feasible and highly effective in newly diagnosed eligible patients, but also in the salvage situation. Usually, this aggressive treatment approach is only offered to patients younger than 65 years of age. However, age alone may not be the only criterion to select patients for this effective treatment approach. In the present study, we plan to summarize feasibility, safety, and outcome of HCT-ASCT followed by ASCT in elderly PCNSL patients (> 65 years) treated at four different centers (Germany and United Kingdom) experienced in treating PCNSL patients.

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Organizational Data

  •   DRKS00009037
  •   2015/08/17
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  •   yes
  •   Approved
  •   12/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   C85.9 -  Non-Hodgkin lymphoma, unspecified
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Interventions/Observational Groups

  •   Investigation of outcome and feasibility of high-dose chemotherapy followed by autologous stem cell transplantation in elderly PCNSL patients.
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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)
  •   N/A
  •   No
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Primary Outcome

Progression Free Survival (PFS)

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Secondary Outcome

Remission status before HCT-ASCT
Adverse events during HCT-ASCT
Remission status after HCT-ASCT
Overall Survival (OS)

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Countries of Recruitment

  •   Germany
  •   United Kingdom
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Locations of Recruitment

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

  •   Actual
  •   2015/03/01
  •   24
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

Immunocompetent patients with biopsy proven PCNSL who underwent HDT-ASCT, age at diagnosis >/=65 years

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Exclusion Criteria

Congenital or acquired immunodeficiency, age < 65 years

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
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    • Klinikum Stuttgart
    • Mr.  Dr.  Benjamin  Kasenda 
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    • Universitätsklinikum Freiburg
    • Ms.  Dr.  Elisabeth  Schorb 
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
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    • Innere Medizin I, Universitätsklinikum Freiburg
    • Ms.  Dr.  Elisabeth  Schorb 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinik Freiburg, Klinik für Innere Medizin I
    • Hugstetter Straße 55
    • 79106  Freiburg
    • 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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