MT-R Followed by Autologous Stem Cells Transplantation in Newly-diagnosed Primary Central Nervous System Lymphoma

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of chemotherapy with MT-R followed by autologous stem cells transplantation in newly-diagnosed primary central nervous system lymphoma.

Detailed Description
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It's a single center, single arm, prospective clinical trial. Patients younger than 65 years old with primary central nervous system lymphoma will received four cycles of chemotherapy with rituximab plus high-dose methotrexate and temozolomide as induction therapy, and then received consolidation therapy with autologous stem cell transplant for which the conditioning regimen is Carmustine plus thiotepa.

Official Title
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MT-R Followed by Autologous Stem Cells Transplantation in Newly-diagnosed Primary Central Nervous System Lymphoma

Conditions
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Primary Central Nervous System Lymphoma

Intervention / Treatment
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* Drug: R-MT followed by auto-HSCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary central nervous system diffuse large B-cell lymphoma histologically confirmed by brain biopsy ECOG 0-2 Absence of systemic disease as evaluated by chest-abdomen-pelvis CT scan Leucocytes>3.500/mm3, platelets>130.000/mm3, Bilirubin < 2 mg, transaminases < 2.5 N), creatinine < 150 μM/l, creatinine clearance > 50 ml/min/1.73m2 Age 18-65 years Negative HIV test Signature of informed consent Exclusion Criteria: prior chemotherapy for primary central nervous system lymphoma presence of another cancer (excepting basal cell carcinoma of the skin and cervical carcinoma in situ ) systemic lymphoma (outside the CNS) Isolated ocular lymphoma Immunosuppressed patients (HIV , use of immunosuppressors) Other uncontrolled or progressive disease compromising shot-term survival Severe renal or hepatic disease Patients not legally covered by the French Social Security Inability to swallow the medication

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: R-MT followed by auto-HSCT<br>R-MT followed by auto-HSCT Rituximab 375 mg/m2 d1 MTX 3.5g/m2 d2(0.5g/m2 15min,3g/m2 3h） TMZ 100 mg/m2 d2-6 Q21d*4cycles Auto-HSCT conditioning regimen: BCNU 400mg/m2 d1; Thiotepa 5mg/kg q12h，d2-3 | Drug: R-MT followed by auto-HSCT<br>* Four cycles of Induction therapy: Rituximab 375mg/m2 d1; Methotrexate 3.5g/m2 d2;Temozolomide 100mg/m2 d2-6; for patients who reach a CR, PR, or SD, will proceed to autologous stem cell transplantation: Carmustine 400mg/m2 d1; Thiotepa 5mg/kg q12h, d2-3.<br>* Other names: Rituximab(R);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate |  | 2 years | 
| overall survival |  | 2 years | 
| event-free survival |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary central nervous system lymphoma, rituximab, Methotrexate and Temozolomide, autologous stem cell transplantation, Carmustine and thiotepa