Primary CNS Lymphoma (PCNSL)
Conditions
Keywords
primary CNS lymphoma, chemotherapy, RR, PFS, OS
Brief summary
The purpose of this study is to evaluate the efficacy and safety of FTD regiment (fotemustine, temozolomide and dexamethasone ) for patients with primary CNS lymphoma.
Detailed description
Primary CNS lymphoma (PCNSL) is a rare B-cell variant of non-Hodgkin lymphoma that is confined to the brain, leptomeninges, spinal cord, and eyes. The optimum treatment for patients with PCNSL remains challenging and at present there is no universally accepted therapeutic approach for patients with newly diagnosed disease. The purpose of this study is to evaluate the efficacy and safety of FTD regiment(fotemustine, temozolomide and dexamethasone)contrast with HD-MTX-Ara-C program for patients with primary CNS lymphoma.
Interventions
HD-MTX-Ara-C regimen high-does metrotrexate 3.5g/m2 d1 ivgtt 6h,cytarabine 1g/m2 bid d2-3.Continued use to the end of chemotherapy .Every 21 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles
DRUGFTD regimen
FTD regimen(fotemustine, temozolomide and dexamethasone),fotemustine 100mg/m2 d1 ivgtt,temozolomide 150mg/m2 d1-5 po,dexamethasone 40mg d1-5 ivgtt.Continued use to the end of chemotherapy .Every 28 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles
Sponsors
Zhengzhou University
Mingzhi Zhang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
Age range 14-69 years old;KPS performance status≥60 or ECOG performance status 0-2; Estimated survival time \> 3 months; Histological confirmed PCNSL; None of chemotherapy contraindication;At least one measurable lesion according to RECIST;None of other serious diseases;Patients could be followed up;None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments. volunteers who signed informed consent.
Exclusion criteria
Currently undergoing chemotherapy, radiotherapy and targeted therapy (received chemotherapy within 3 weeks, received radiotherapy within 2 weeks, or has not recovered from any previous treatment of acute toxicity);Patients with uncontrolled medical problems (including active infection, uncontrolled diabetes, severe heart, liver, kidney dysfunction and interstitial pneumonia, etc.); Pregnant or lactating women;Serious medical illness likely to interfere with participation;Chemotherapy contraindication such as cachexia; patients with other malignancies previously;Serious infection;The evidence of peripheral nervous disorder or dysphrenia; patients estimated to be unsuitable by investigato
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | up to end of follow-up-phase(approximately 24 months) | Progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| response rate | every 6 weeks,up to completion of treatment(approximately 18 weeks ) | response rate |
| overall survival | up to the date of death (approximately 5 years) | overall survival |
| median survival time | 24 months | median survival time |
Countries
China
Outcome results
None listed