Trial document





This trial has been registered retrospectively.
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  DRKS00008900

Trial Description

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Title

Pilot study for a phase II trial to evaluate high-dose chemotherapy and autologous stem cell transplant in primary CNS lymphoma patients > 65 years - MARiTA -

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Trial Acronym

MARiTA

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URL of the Trial

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Brief Summary in Lay Language

Primary central nervous system lymphoma is an aggressive Non-Hodgkin
Lymphoma, which exclusively invades the central nervous system
compartment.

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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. It accounts for 3% to 4% of all primary brain tumours and 4% to 6% of extra-nodal lymphomas. The incidence of PCNSL in immunocompetent patients has been steadily increasing over the last 30 years. Patients older than 60 years account for more than 50% of all PCNSL cases.

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Organizational Data

  •   DRKS00008900
  •   2016/02/03
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  •   yes
  •   Approved
  •   344/15(FF-MC), Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   2015-002305-11 
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Health Condition or Problem studied

  •   C83.3 -  Diffuse large B-cell lymphoma
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Interventions/Observational Groups

  •   Induction treatment:
    2 cycles (every 3 weeks), stem-cell harvest after first cycle:
    - Rituximab 375 mg/m² i.v. (d-0,4)
    - MTX 3,5 g/m² i.v. (d1)
    - AraC 2x2 g/m²/d i.v. (d2-3)

    Consolidation:
    High-dose chemotherapy:
    - Busulfan 3,2 mg/kg/d i.v. (d-7-(-6))
    - Thiotepa 5 mg/kg/d i.v. (d-5-(-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)
  •   N/A
  •   No
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Primary Outcome

Evaluation of feasibility of the study procedures.
Progression-free survival (PFS) as time from start of treatment until progression, relapse or death from any cause, whatever happens first

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Secondary Outcome

Key secondary endpoint(s):
•Recruitment rate
•Rate of complete responses (CR) on day +30 after HDT-ASCT
•Progression-free survival (PFS) from start of treatment until progression, relapse or death from any cause
•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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2015/12/04
  •   15
  •   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 or relapsed primary central nervous system B-cell lymphoma
2. Age > = 65 years as well as patients between 65 and 70 years years old, that are not eligible for treatment within the MATRix/IELSG43
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, liquor or cranial nerves
6. At least one measurable lesion
7. Cumulative Illness Rating Scale-Geriatric (CIRS-G) <6
8. ECOG-Performance Status ≤ 2
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 bone marrow (platelet count decreased ≥CTC grade 1, anemia ≥CTC grade 1, neutrophil count decreased ≥CTC grade 1), renal (creatinine clearance <60 ml/min), cardiac (ejection fraction decreased ≥CTC grade 2), or hepatic function (blood bilirubin increased ≥CTC grade 2, alanine aminotransferase increased ≥CTC grade 2, aspartate aminotransferase increased ≥CTC grade 2 or gamma-GT increased ≥CTC grade 2)
7. HBsAg, anti-HBc or HCV positivity
8. HIV infection, previous organ transplantation or other clinical evident form of immunodeficiency
9. Concurrent treatment with other experimental drugs or participation in a clinical trial within the last thirty days before the start of this study
10.Symptomatic coronary artery disease, cardiac arrhythmias uncontrolled with medication or myocardial infarction within the last 6 months (New York Heart Association Class III or IV heart disease)
11. Severe non-compensated pulmonary disease (IVC <55%, DLCO <40%)
12.Third space fluid accumulation >500 ml
13.Hypersensitivity to study treatment or any component of the formulation
14.Taking any medications likely to cause interactions with the study medication
15.Known or persistent abuse of medication, drugs or alcohol
16.Patient without legal capacity and who is unable to understand the nature, significance and consequences of the study and without designated legal representative
17.Persons who are in a relationship of dependency/employment to the sponsor and/ or investigator
18.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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    • Albert-Ludwigs-Universität Freiburg Medizinische Fakultät, Dekanat
    • Elsässer Strasse 2m
    • 79110  Freiburg im Breisgau
    • Germany
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    • Studienzentrum Universitätsklinikum Freiburg
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    • Universitätsklinikum Freiburg Medizinische Klinik Hämatologie, Onkologie und Stammzelltransplantation
    • Ms.  Dr.med.  Elisabeth  Schorb 
    • Hugstetter Straße 55
    • 79106  Freiburg
    • 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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Sources of Monetary or Material Support

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    • Ministerium für Wissenschaft, Forschung und Kunst, Baden-Württemberg
    • Königstraße 46
    • 70173  Stuttgart
    • Germany
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    • Universitätsklinikum Freiburg
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/02/04
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Trial Publications, Results and other Documents

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