Trial document




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  DRKS00000582

Trial Description

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Title

Methotrexate-based Chemo-immunotherapy Followed by Maintenance Therapy for Patients > 65 Years With Central Nervous System (CNS)-Lymphoma (PRIMAIN)

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Trial Acronym

PRIMAIN-Studie

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The most important part of the treatment of primary cns lymphoma (PCNSL) is highdose methotrexate (MTX). MTX is given either alone or in combination with different cytostatic drugs, which can reach the brain. In up to 80% of the patients the lymphoma disappears under treatment. But in most of the patients it appears again. Radiation therapy of the brain after chemotherapy reduces the risk of relapse. But, especially in patients older than 60 years, it can reduce the function of the brain as a side effect. In this study the efficacy of a MTX-based therapy in patients with PCNSL older than 65 years is analyzed. High dose MTX is combined with two cytostatics, procarbacine and lomustine. These drugs can reach the cns and are given orally. In addition to the cytostatic treatment the antibody rituximab is given which recognizes typical proteins at the surface of the lymphoma cells. Following the treatment, a 6-month consolidation therapy with procarbacine orally is added for 5 days every 4 weeks.

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Brief Summary in Scientific Language

The most important part of the treatment of primary cns lymphoma (PCNSL) is highdose methotrexate (MTX). It is given either alone of in combination with other cytostatics which can reach the cns compartment. Although remission rates up to 80 % are reached, most of the patients relapse. Subsequent whole brain radiation therapy (WBRT) can elevate remission rates but it also, especially in patients older than 60 years, can cause severe leukencephalopathy. In this study the efficacy of a MTX-based immuno-chemotherapy in patients older than 5 years with newly diagnosed PCNSL is analysed. Highdose MTX is combined with the oral lipophilic alkylating agents lomustine and procarbacine. In addition the the cytostatic therapy the monoclonal antibody rituximab is added for all patients with CD 20 positive PCNSL. Subsequently, a 6 months consolidation therapy with oral procarbacine for 5 days every 4 weeks is given.

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Organizational Data

  •   DRKS00000582
  •   2010/10/29
  •   2009/10/30
  •   yes
  •   Approved
  •   081/09, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   2008-007645-31 
  •   UKF001935  (Register klinischer Studien des Universitätsklinikums Freiburg)
  •   4035099 
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Health Condition or Problem studied

  •   primär cerebrales Lymphom
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   day -6: Rituximab 375mg/m²

    R-MPL
    - day 1, 15, 29 Rituximab 375mg/m²
    - day 2, 16, 30 MTX 3000 mg/m² 4h i.v.
    - Leukovorinrescue 24h after start of MTX
    - day 2: Lomustin 110 mg/m² p.o.
    - day 2 - 11: Procarbazin 60 mg/m² p.o.
    repeat day 43, in total 3 cycles

    maintenance:
    - from day 43 after the last cycle of R-MPL
    - Tag 1-5 Procarbazin 100mg abs. p.o./day
    repeat day 29
    in total 6 cycles
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Historical
  •   Treatment
  •   Single (group)
  •   II
  •   [---]*
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Primary Outcome

Complete remission rate [ Time Frame: 30 days after end of immuno-chemotherapy ]

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Secondary Outcome

1. Duration of response [ Time Frame: within 5 years ] [ Designated as safety issue: No ]
2.Overall survival time [ Time Frame: within 5 years ] [ Designated as safety issue: No ]
3. Neuropsychological state (according to Mini-Mental State and IPCG testing) [ Time Frame: within 5 years ] [ Designated as safety issue: Yes ]
4. (Serious) adverse events ([S]AEs) [ Time Frame: within 30 days after treatment ] [ Designated as safety issue: Yes ]

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/10/09
  •   112
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

-first diagnosis of PCNSL, histologically confirmed
-age > 65 years
-written signed and dated informed consent of the legal representative and - if possible - of the patient

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Exclusion Criteria

* manifestations of further lymphoma outside the CNS
* sero-positive for HIV
* severe pulmonary, cardiac, hepatic, renal impairment
* uncontrolled infection
* neutrophil count < 1.500/µl, platelet count < 100.000/µl
* pulmonary disease with IVC < 55%, DLCO < 40%
* cardiac ejection fraction < 50%, uncontrolled malign arrhythmia
* creatinine > 1,5 mg% or creatinine-clearance < 50ml/min
* bilirubin > 2mg/dl
* ascites or pleural effusion (> 500ml)
* known hypersensitivity against methotrexate, lomustine, procarbazine, rituximab, leukovorin, or dexamethasone
* participation in another clinical trial within the last 30 days prior to the begin or parallel to this study
* known or current drug or alcohol abuse

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Addresses

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    • Universitätsklinikum Freiburg - vertreten durch: Leitenden Ärztlichen Direktor
    • Hugstetter Strasse 49
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Innere Medizin - Hämatologie / Onkologie
    • Mr.  Prof. Dr. med.  Gerald  Illerhaus 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Innere Medizin - Hämatologie / Onkologie
    • Mr.  Prof. Dr. med.  Gerald  Illerhaus 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg Innere Medizin - Hämatologie / Onkologie
    • Mr.  Prof. Dr. med.  Gerald  Illerhaus 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/05/06
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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.