A Phase II Trail of Chidamide ,Rituximab and Methotrexate in Lymphoma Patients

NCT ID: NCT04516655

Last Updated: 2020-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2023-08-30

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 every 21-day cycle for 6 cycles in untreated patients with primary central nervous system lymphoma.

The primary study endpoint will be complete response (CR) rate as assessed by the investigator. The hypothesis is previously untreated patients with primary central nervous system lymphoma could achieve a CR rate of 80% with C-R-HDMTX.

Conditions

Central Nervous System Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

C-R-MTX

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 every 21-day cycle for 6 cycles

Group Type: EXPERIMENTAL

chidamide combined with rituximab and high-dose methotrexate

Intervention Type: DRUG

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 every 21-day cycle for 6 cycles in untreated patients with primary central nervous system lymphoma

Interventions

chidamide combined with rituximab and high-dose methotrexate

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 every 21-day cycle for 6 cycles in untreated patients with primary central nervous system lymphoma

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. ECOG Performance Status of 0, 1, or 2

2. Previously untreated patients with primary central nervous system lymphoma with pathologically confirm

3. At least one bi-dimensionally measurable lesion, defined as >1.0 cm in its longest dimension as measured by MRI

4. Signed written Informed Consent Form

5. 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

6. 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 Criteria

1. Evidence of extracranial involvement (such as testis and breast) and secondary CNS involvement

2. Evidence of pleural fluid, ascites and pericardial effusion

3. History or presence of prolonged QTc interval in ECG, QTc interval>470ms in female and >450ms in male

4. History of other malignancy in 5 years

5. Positive test results for hepatitis C, HIV and RPR.

6. 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.

7. Pregnancy or lactation or intending to become pregnant during study

8. Prior organ transplantation

9. 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.

10. Evidence of significant, uncontrolled, epilepsy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Fangfang Lv, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fangfang Lv

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Central Contacts

Fangfang Lv

Role: CONTACT

lvff80@163.com

+86-18018312613

Jia Jin

Role: CONTACT

jinjia195@126.com

+86-18017317721

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Other Identifiers

C-R-HDMTX

Identifier Type: -

Identifier Source: org_study_id