Trial document




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  DRKS00011932

Trial Description

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Title

Age-adjusted high-dose chemotherapy and autologous stem cell transplant in elderly and fit primary CNS lymphoma patients

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Trial Acronym

MARTA

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URL of the Trial

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Brief Summary in Lay Language

The planned trial investigates the tolerability and efficacy of a highdose chemotherapy and autologous stemcell transplantation in fit and elderly patients with newly diagnosed primary central nervous system lymphoma, which is an aggressive non-Hodgkin lymphoma, which exclusively invades the central nervous system
compartment. All medication used in this study has market authorization and is being applied for the treatment of this disease for many years for patients < 70 years of age. However, patients older than 60 years account for more than 50% of all PCNSL cases. For this reason this trial plans to use these drugs in an adjusted form for the treatment of patients > 70 years of age.

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Brief Summary in Scientific Language

Primary central nervous system lymphoma (PCNSL) is an aggressive Non-Hodgkin Lymphoma (NHL) mostly of B-cell origin, which exclusively invades the central nervous system compartment. The incidence of PCNSL in immunocompetent patients has been steadily increasing over the last 30 years. Patients older than 60years account for more than 50% of all PCNSL cases.

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Organizational Data

  •   DRKS00011932
  •   2017/08/18
  •   [---]*
  •   yes
  •   Approved
  •   174/17, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   2016-001628-72 
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Health Condition or Problem studied

  •   C85.1 -  B-cell lymphoma, unspecified
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Interventions/Observational Groups

  •   Induction treatment:
    2 cycles (every 3 weeks), stem-cell harvest after first cycle:
    - Rituximab 375 mg/m²/d i.v. (d0,4)
    - MTX 3,5 g/m² i.v. (d1)
    - AraC 2x2 g/m²/d i.v. (d2-3)

    Consolidation:
    High-dose chemotherapy:
    - Rituximab 375 mg/m² i.v. (d-8)
    - Busulfan 3,2 mg/kg/d i.v. (d-7 and d-6)
    - Thiotepa 5 mg/kg/d i.v. (d-5 and d-4)
    - ASCT (d0)
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
  •   No
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Primary Outcome

Primary endpoint: progression free survival (PFS) at 1 year: time from start of treatment until disease progression or death from any cause, whichever occurs first.

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Secondary Outcome

•Rate of complete responses (CR) on day +30 after HDT-ASCT
•Progression-free survival (PFS) as time from start of treatment until progression, relapse or death from any cause, whatever happens first
•Overall survival (OS) as time from start of treatment until death from any cause
•Rate of neurotoxicity on day + 30 after HDT-ASCT and continuously thereafter
•Non relapse mortality (NRM)
•(Serious) adverse events ([S]AEs): from the first administration of the study medication until day 30 after HDT-ASCT

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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

  •   Actual
  •   2017/11/29
  •   51
  •   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

Key inclusion criteria:
1. Immunocompetent patients with newly-diagnosed primary central nervous system B-cell lymphoma.
2. Age > 65 years plus patients between 65-70 years, who are not eligible for treatment within the MATRix/IELSG43 trial.
3. Histologically or cytologically assessed diagnosis of B-cell lymphoma by local pathologist.
4. Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy.
5. Disease exclusively located in the CNS.
6. At least one measurable lesion.
7. ECOG-Performance Status ≤ 2.
8. Patients eligible for intensive treatment according to physician´s choice.
9. Written informed consent obtained according to international guidelines and local laws by patient or authorized legal representative in case patient is temporarily legally not competent due to his or her disease.

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Exclusion Criteria

Key exclusion criteria:
1. Congenital or acquired immunodeficiency.
2. Systemic lymphoma manifestation (outside the CNS).
3. Isolated ocular lymphoma without manifestation in the brain parenchyma or spinal cord.
4. Previous or concurrent malignancies with the exception of surgically cured carcinoma in-situ of the cervix, carcinoma of the skin or other kinds of cancer without evidence of disease for at least 5 years.
5. Previous systemic Non-Hodgkin lymphoma at any time.
6. Inadequate renal function (creatinine clearance <60 ml/min).
7. Inadequate hepatic, cardiac or pulmonary function according to physician`s decision.
8. Active hepatitis B or C disease.
9. HIV infection, previous organ transplantation or other clinical evident form of immunodeficiency.
10. Concurrent treatment with other experimental drugs or participation in a clinical trial within the last thirty days before the start of this study.
11. Third space fluid accumulation >500 ml.
12. Hypersensitivity to study treatment or any component of the formulation.
13. Taking any medications likely to cause interactions with the study medication.
14. Known or persistent abuse of medication, drugs or alcohol.
15. Patient without legal capacity and who is unable to understand the nature, significance and consequences of the study and without designated legal representative.
16. Persons who are in a relationship of dependency/employment to the sponsor and/ or investigator.
17. Any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

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Addresses

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    • Universitätsklinikum FreiburgMedizinische Klinik IHämatologie, Onkologie und Stammzelltransplantation
    • Ms.  Dr. med.  Elisabeth  Schorb 
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
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    • Klinikum Stuttgart; Klinik für Hämatologie, Onkologie und Palliativmedizin; Stuttgart Cancer Center / Tumorzentrum Eva Mayr-Stihl
    • Mr.  Prof.Dr.med.  Gerald  Illerhaus 
    • Kriegsbergstr.60
    • 70174  Stuttgart
    • Germany
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    • Universitätsklinikum FreiburgMedizinische Klinik IHämatologie, Onkologie und Stammzelltransplantation
    • Ms.  Dr.med.  Elisabeth  Schorb 
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgStudienzentrum
    • Ms.  Elvira  Burger 
    • Elsässer Straße 2
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Else Kröner Fresenius-Stiftung
    • Am Pilgerrain 15
    • 61352  Bad Homburg v.d.Höhe
    • Germany
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    • Riemser Pharma GmbHvertreten durch die Geschäftsführung und/ oder Prokuristen
    • An der Wiek 7
    • 17493  Greifswald-Insel Riems
    • Germany
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Status

  •   Recruiting suspended on temporary hold
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Trial Publications, Results and other Documents

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