Overview
MT-R Followed by Autologous Stem Cells Transplantation in Newly-diagnosed Primary Central Nervous System Lymphoma
Status:
Unknown status
Unknown status
Trial end date:
2019-04-01
2019-04-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Jun ZhuTreatments:
Carmustine
Methotrexate
Rituximab
Temozolomide
Thiotepa
Criteria
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