Clinical Trial: Maintenance Treatment Versus Observation in Elderly Patients With PCNS Lymphoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase III Trial Evaluating Maintenance Treatment Versus Observation in Elderly Patients Suffering From Primary Central Nervous System Lymphoma in Complete Remission After

Brief Summary:

Hypothesis

Our hypothesis is that maintenance chemotherapy will prolong complete remission obtained after a standard induction chemotherapy with an acceptable toxicity in the elderly.

Rationale

  • Treatment of the elderly is challenging, indeed age over 60 is associated both with a poor prognosis and a high risk of treatment induced neurotoxicity with devastating consequences on quality of life. Therefore it has become standard practice to treat elderly in first line with high-dose methotrexate (MTX) based polychemotherapy alone, avoiding whole brain radiotherapy (WBRT) or deferring it for recurrence.
  • There is a clear need to improve disease control after induction chemotherapy. Since consolidation with WBRT or intensive chemotherapy with autologous stem cell rescue are either poorly effective and/or too toxic in the elderly population, maintenance chemotherapy is an interesting alternative approach. Several agents, such as high-dose MTX, temozolomide (TMZ), rituximab, with a reported activity in PCNSL and acceptable safety profile, as single agent or combined, are good candidates for maintenance

Detailed Summary:

Objectives

  • The primary objective is to evaluate the benefit estimated by the PFS associated with maintenance chemotherapy compared to observation in patients ≥ 60 years having achieved a complete response after a high-dose MTX based induction chemotherapy

  • The secondary objectives are to assess:

    • Overall survival
    • Safety of maintenance chemotherapy
    • Neurocognitive outcome
    • Quality of life of the patients

Inclusion and exclusion criteria

At registration

  • Inclusion criteria

    • Newly diagnosed primary cerebral lymphoma
    • Age >60 years
    • Pathology proven diagnosis
    • Positive cytology of the CSF or vitreous
    • Karnofsky Performance Status >40
    • No evidence of systemic NHL (body CT scan, bone marrow biopsy)
    • Adequate haematological, renal and hepatic function
    • Calculated creatinine clearance > 40 ml/min

  • Non inclusion criteria

    • Positive HIV serology

      • Sponsor: Assistance Publique - Hôpitaux de Paris

      Current Primary Outcome: progression free survival [ Time Frame: 6 years ]

      Original Primary Outcome: Same as current

      Current Secondary Outcome:

      • overall survival [ Time Frame: 6 years ]
      • Toxicity graded according to the NCI-CTCAE [ Time Frame: 6 years ]
        Toxicity graded according to the NCI-CTCAE
      • Cognitive functions evaluated by a standardized and validated test battery exploring 5 cognitive domains [ Time Frame: 6 years ]
        Cognitive functions evaluated by a standardized and validated test battery exploring 5 cognitive domains
      • Quality of life [ Time Frame: 6 years ]
        Quality of life assessed by the EORTC QLC-C30 questionnaire and the brain cancer module (BCM20)


      Original Secondary Outcome: Same as current

      Information By: Assistance Publique - Hôpitaux de Paris

      Dates:
      Date Received: December 5, 2014
      Date Started: September 2015
      Date Completion: June 2021
      Last Updated: November 4, 2016
      Last Verified: November 2016