Primary Central Nervous System Lymphoma
Conditions
Keywords
Primary Central Nervous System Lymphoma, RL-MT
Brief summary
This is a prospective single arm, multi-center, phase II clinical trial to observe the efficacy and safety of Rituximab, Lenalidomide combined with high-dose Methotrexate and Temozolomide (RL-MT) in the first-line treatment for patients with primary central nervous system lymphoma.
Interventions
DRUGMethotrexate
Induction Chemotherapy: 3mg/m2, Intravenous administration (pumping for 3h) on day 1 of each 3-week cycle until disease progression/stable disease or unacceptable toxicity develops, up to 6 cycles.
DRUGTemozolomide
Induction Chemotherapy: 150mg/m2/d oral administration on day 1 to 10 of each 3-week cycle until disease progression/stable disease or unacceptable toxicity develops, up to 6 cycles.
DRUGRituximab
Induction Chemotherapy: 375mg/m2, Intravenous administration on day 0 of each 3-week cycle until disease progression/stable disease or unacceptable toxicity develops, up to 6 cycles.
DRUGLenalidomide
Induction Chemotherapy: 25mg, oral administration on day 1 to 10 of each 3-week cycle until disease progression/stable disease or unacceptable toxicity develops, up to 6 cycles. Maintenance Treatment: 10mg oral administration on day 1 to 21 repeated every 4 weeks until disease progression or unacceptable toxicity develops, up to 12 cycles.
Sponsors
Henan Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 to 70 years old (including 18 and 70) 2. Diagnosed as primary central nervous system lymphoma (limited to the brain, spinal cord, meninges and eyeballs, without involvement of other parts) 3. Having not received anti-tumor therapy before enrollment (except for tumor resection and biopsy and the use of glucocorticoids to reduce central nervous system symptoms) 4. Having at least one measurable lesions 5. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2 ( ECOG 3 due to tumors can be included after being fully assessed by the investigator) 6. Life expectancy no less than 1 month 7. enough main organ function 8. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study 9. Agreeing to sign the written informed consents
Exclusion criteria
1. Diagnosed as secondary central nervous system lymphoma 2. Diagnosed as CD20 negative large B cell primary central nervous system lymphoma 3. Active malignant tumor need be treated at the same time 4. Other malignant tumor history 5. Serious surgery and trauma less than two weeks 6. Patients with active tuberculosis 7. Systemic therapy for serious acute/chronic infection 8. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months 9. HIV-positive, AIDS patients and untreated active hepatitis 10. Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months 11. Patients with a history of mental illness or drug abuse 12. Poor compliance during the trial and/or follow-up phase 13. Allergies or people who are known to be allergic to any active ingredients, excipients, mouse-derived products or heterologous protein contained in this trial 14. Researchers determine unsuited to participate in this trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year progression-free survival | from the day of the first cycle of treatment to the date of confirmed progressive disease or death, whichever occurs first, up to 2 years after last patient's enrollment (each cycle is 21 days) | the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurs first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate | every 6 weeks from the day of the first cycle of induction chemotherapy treatment and every 8 weeks from the day of the first cycle of maintenance treatment to 18 months after last patient's enrollment (each cycle is 21 days) | the total proportion of patients with complete response (CR) and partial response (PR) |
| overall survival | from date of the first cycle of treatment to the date of death from any cause, assessed up to 5 years (each cycle is 21 days) | from date of first day of treatment to the date of death by any cause |
| incidence and relationship with study drugs of grade 3-4 adverse events | from the date of the first cycle of treatment to 18 months after last patient's enrollment (each cycle is 21 days) | the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v4.03) |
Countries
China
Contacts
Primary ContactZhihua Yao, M.D. Ph.D
Backup ContactYanyan Liu, M.D. Ph.D
Outcome results
None listed