Combination of rituximab and methotrexate followed by rituximab and cytarabine in elderly patients with primary CNS lymphoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0003146

Enrollment

Registered

2018-08-29

Start date

2018-07-01

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

eliminated ? After Induction therapy (Rituximab-Methotrexate) was added 3 times (total 5 times), 2nd evaluation •Complete response -&gt

Drug : Drug: Rituximab 500 mg/m2 + 5&#37

DW 500 mL IVF Begin with 50 mg/hr (increase by 50 mg/hr per 30 min until 400 mg/hr is reached) Drug: Methotrexate 500 mg/m2 + 5&#37

DW 200 mL IV over 15 minutes 3000 mg/m2 + 5&#37

DW 500 mL IVF over 3 hrs Concurrent hydration and subsequent leucovorin rescue is mandatory Drug: Cytarabine 3000 mg/m2 + 5&#37

DW 200 mL IVF over 2 hrs steroid eye drop 0.1&#37

, 2 drops q 6hrs, on days 1-9 Experimental: Induction+Consolidation chemotherapy [Induction phase] ? After induction therapy (Rituximab-Methotrexate) 2 times, first evaluation •Complete, partial r

next step •Progressive disease-&gt

consolidation therapy(Rituximab-Cytarabine) progress •Partial response or stable disease-&gt

Rituximab-Methotrexate 2 additional administrations •Progressive disease-&gt

eliminated ? After Induction therapy (Rituximab-Methotrexate) was added twice (7 times in total), 3rd evaluation •Complete, partial response or stable disease-&gt

consolidation therapy(Rituximab-Cytarabine) •Progressive disease-&gt

eliminated

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: <Inclusion criteria> 1. Histologically proven diagnosis of B-cell non-Hodgkin’s lymphoma, exclusively localized in the central nervous system, cranial nerves, and/or eyes 2. No previous treatment; A tumorectomy on diagnostic purpose and/or use of glucocorticoids is allowed 3. Measurable lesion(s) 4. Age = 60 years 5. Unfit patients for high-dose chemotherapy followed by autologous stem cell transplantation 6. Adequate organ functions - Absolute Neutrophil Count (ANC) = 1.0 x 109/L - Platelets = 50 x 109/L - Hemoglobin = 8.0 g/dL - Serum Creatinine = 1.5 x upper limit normal (ULN) - Serum Bilirubin = 1.5 x ULN - AST and ALT = 3 x ULN 7. Patients with adequately controlled HBV, HCV or HIV are allowed. In case of HBV (+), adequate anti-viral prophylaxis should be incorporated. In case of HIV (+), highly active anti-retroviral therapy should be incorporated. 8. Written informed consent 9. ECOG performance scale 0, 1 or 2 10. Life expectancy > 3 months

Exclusion criteria

Exclusion criteria: <Exclusion criteria> 1. T-cell or NK/T cell lymphoma 2. Any evidence of systemic non-Hodgkin’s lymphoma as demonstrated by computed tomography scan of the neck, chest, abdomen, and pelvis and bone marrow examinations 3. Young and fit patients who are suitable for high-dose chemotherapy followed by autologous stem cell transplantation 4. Prior radiation therapy on target CNS lesion(s) 5. Concurrent severe or uncontrolled medical conditions, laboratory abnormalities or psychiatric disorders that would preclude the participants in the study by the discretion of attending physicians 6. Metachronous malignancy other than adequately treated basal cell or squamous cell carcinoma of the skin, or CIN of uterine cervix, or prostate cancer that can be observed without treatment 7. Known hypersensitivity to the investigational agent(s)

Design outcomes

Primary

Measure	Time frame
2-year progression free survival rate	—

Secondary

Measure	Time frame
overall response rate;time to treatment failure;progression free survival;overall survival;safety profiles	—

Countries

Korea, Republic of

Contacts

Public ContactKaeun Park

Samsung Medical Center

kaeun.park@samsung.com+82-70-7014-4162

Outcome results