Status:
UNKNOWN
A Phase II Trail of Chidamide ,Rituximab and Methotrexate in Lymphoma Patients
Lead Sponsor:
Fudan University
Conditions:
Central Nervous System Lymphoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This study will evaluate the efficacy, safety and patient reported outcomes of chidamide 20 mg biw PO day1-14 and rituximab 375 mg/m2 IV given on day 1 and methotrexate 3.5g/m2 IV given on day 2 of ev...
Eligibility Criteria
Inclusion
- ECOG Performance Status of 0, 1, or 2
- Previously untreated patients with primary central nervous system lymphoma with pathologically confirm
- At least one bi-dimensionally measurable lesion, defined as \>1.0 cm in its longest dimension as measured by MRI
- Signed written Informed Consent Form
- hematologic function,defined as follows:
- Hemoglobin ³ 9.0 g/dL without packed RBC transfusion during 14 days before first treatment
- ANC ³ 1,000/µL
- Platelet count ³ 80,000/µL
- Adequate liver and kidney function function,defined as follows:
- Serum AST and ALT≤ 2.5 \*ULN ，Total bilirubin ≤ 1.5 \* ULN Serum creatinine clearance ≥ 50 mL/min (using Cockcroft-Gault formula)
Exclusion
- Evidence of extracranial involvement (such as testis and breast) and secondary CNS involvement
- Evidence of pleural fluid, ascites and pericardial effusion
- History or presence of prolonged QTc interval in ECG, QTc interval\>470ms in female and \>450ms in male
- History of other malignancy in 5 years
- Positive test results for hepatitis C, HIV and RPR.
- Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \[HBsAg\] serology) Patients with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) DNA is less than 10E4 at the time of screening.
- Pregnancy or lactation or intending to become pregnant during study
- Prior organ transplantation
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment or significant infections within 2 weeks before the start of Cycle 1.
- Evidence of significant, uncontrolled, epilepsy
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2023
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04516655
Start Date
September 1 2020
End Date
August 30 2023
Last Update
August 18 2020
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