A Phase II Trail of Chidamide ,Rituximab and Methotrexate in Lymphoma Patients (C-R-HDMTX)
Primary Purpose
Central Nervous System Lymphoma
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
chidamide combined with rituximab and high-dose methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Central Nervous System Lymphoma
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
C-R-MTX
Arm Description
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04516655
Brief Title
A Phase II Trail of Chidamide ,Rituximab and Methotrexate in Lymphoma Patients
Acronym
C-R-HDMTX
Official Title
A Phase II, Single-arm Trail of Chidamide Combined With Rituximab and High-dose Methotrexate in Previously Untreated Patients With Primary Central Nervous System Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Nervous System Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
C-R-MTX
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
chidamide combined with rituximab and high-dose methotrexate
Intervention Description
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
Primary Outcome Measure Information:
Title
CR rate
Description
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
Time Frame
up to 18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fangfang Lv
Phone
+86-18018312613
Email
lvff80@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Jin
Phone
+86-18017317721
Email
jinjia195@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fangfang Lv
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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A Phase II Trail of Chidamide ,Rituximab and Methotrexate in Lymphoma Patients
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