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

Study Overview
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Brief Summary
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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.

Official Title
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Combined Systemic and Intrathecal Chemotherapy Followed by High-dose Chemotherapy and Autologous Stem Cell Transplantation for CNS Relapse of Aggressive Lymphomas

Conditions
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Lymphoma, Non-Hodgkin

Intervention / Treatment
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* Drug: Combined systemic and intrathecal chemotherapy followed by HD-ASCT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systemic and intrathecal chemotherapy<br> | Drug: Combined systemic and intrathecal chemotherapy followed by HD-ASCT<br>* Methotrexate Ifosfamide Cytarabine Thiotepa Liposomal cytarabine (intrathecal) Carmustine Etoposide Autologous stem cell transplantation<br>* Other names: BCNU;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to treatment failure |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 2 years | 
| Remission rate |  | 3 months | 
| Toxicity |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CNS relapse, aggressive lymphoma, HD-ASCT