MT-R Followed by Autologous Stem Cells Transplantation in Newly-diagnosed Primary Central Nervous System Lymphoma
Phase 2
- Conditions
- Primary Central Nervous System Lymphoma
- Interventions
- Drug: R-MT followed by auto-HSCT
- Registration Number
- NCT02399189
- Lead Sponsor
- Jun Zhu
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 39
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description R-MT followed by auto-HSCT R-MT followed by auto-HSCT 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
- Primary Outcome Measures
Name Time Method progression-free survival 2 years
- Secondary Outcome Measures
Name Time Method overall survival 2 years overall response rate 2 years event-free survival 2 years
Trial Locations
- Locations (1)
Lijuan Deng
🇨🇳Beijing, Beijing, China