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

Charité University Medicine Berlin

Status and phase

Unknown

Phase 2

Conditions

Lymphoma, Non-Hodgkin

Treatments

Drug: Combined systemic and intrathecal chemotherapy followed by HD-ASCT

Study type

Interventional

Funder types

Other

Identifiers

NCT01148173

NHL-ZNS-Rezidiv

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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