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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-MT followed by auto-HSCT | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R-MT followed by auto-HSCT | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate | 2 years | |
| overall survival | 2 years | |
| event-free survival |
| Measure | Description | Time Frame |
|---|---|---|
| neurotoxicity | using a battery of cognitive and quality-of-life (QoL) measures | 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| lijuan deng, MD | Contact | 1099196109 | lijuan_deng@hotmail.com | |
| Yuqin Song, MD | Contact | 1088196109 | songyuqin622@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Zhu, MD | Peking University Cancer Hospital & Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lijuan Deng | Recruiting | Beijing | Beijing Municipality | 100142 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17284616 | Result | Correa DD, Maron L, Harder H, Klein M, Armstrong CL, Calabrese P, Bromberg JE, Abrey LE, Batchelor TT, Schiff D. Cognitive functions in primary central nervous system lymphoma: literature review and assessment guidelines. Ann Oncol. 2007 Jul;18(7):1145-51. doi: 10.1093/annonc/mdl464. Epub 2007 Feb 6. |
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| 2 years |