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

NCT04516655 | Unknown Phase 2

• 1 other identifier: C-R-HDMTX
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• CR rate

  CR rate of the lesion of previously untreated patients with primary central nervous system lymphoma according to the international collaborative evaluation criteria for central nervous system lymphoma （2005）with Enhanced MRI every 2 cycles

  up to 18 weeks

Study Arms (1)

C-R-MTX

EXPERIMENTAL

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

Drug: chidamide combined with rituximab and high-dose methotrexate

Interventions

chidamide combined with rituximab and high-dose methotrexate 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

C-R-MTX

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

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MeSH Terms

Interventions

Rituximab; Methotrexate

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Fangfang Lv

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fangfang Lv

CONTACT

+86-18018312613; lvff80@163.com

Jia Jin

CONTACT

+86-18017317721; jinjia195@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 18, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: August 30, 2023
• Last Updated: August 18, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share