High-dose Chemotherapy and Stem Cell Transplantation for Central Nervous System (CNS) Relapse of Aggressive Lymphomas

• Status: Unknown status
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Central nervous system (CNS) relapses of aggressive lymphomas are a rare but devastating complication. There is no therapy standard, conventional approaches are palliative. This study investigates an intensive chemotherapy with CNS penetrating drugs followed by high-dose chemotherapy and autologous stem cell transplantation as a potentially curative approach.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Treatments: Ifosfamide

Criteria

Inclusion Criteria:

• highly-malignant non-Hodgkins-Lymphoma, mantle-cell lymphoma or follicular lymphoma 3°

• CNS relapse (meningeal or/and intraparenchymal) with or without systemic lymphoma manifestations

• ECOG performance score ≤2

• no active infection

• negative HIV-serology

• adequate renal function (creatinine clearance > 50 ml/min)

• adequate bone marrow function (granulocytes >1500/μl, platelets > 80000/μl)

• normal bilirubin, AST < 3 x UNL

• negative pregnancy test

Exclusion Criteria:

• newly diagnosed NHL with primary CNS involvement

• indolent NHL, lymphoblastic NHL or Burkitt lymphoma

• preceding CNS irradiation

• pretreatment of CNS relapse other than corticosteroids

• immunosuppression, concomitant immunosuppressive therapy, status after organ transplantation or allogenous stem cell transplantation

• second cancer other than basalioma or cervical carcinoma in situ within the last 5 years

• unfit to receive an intensive chemotherapy

• pregnancy or breastfeeding

• known intolerance to MTX, ifosfamide, Depocyte, cytarabine, thiotepa, carmustine or etoposide