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

Central Nervous System Lymphoma Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04516655
• Other study ID #: C-R-HDMTX
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 1, 2020
• Est. completion date: August 30, 2023

Study information

• Verified date: August 2020
• Source: Fudan University
• Contact: Fangfang Lv
• Phone: +86-18018312613
• Email: lvff80[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 51
• Est. completion date: August 30, 2023
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Lymphoma
• Lymphoma

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

References & Publications (25)

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Batchelor TT. Primary central nervous system lymphoma: A curable disease. Hematol Oncol. 2019 Jun;37 Suppl 1:15-18. doi: 10.1002/hon.2598. Review. — View Citation

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Thiel E, Korfel A, Martus P, Kanz L, Griesinger F, Rauch M, Röth A, Hertenstein B, von Toll T, Hundsberger T, Mergenthaler HG, Leithäuser M, Birnbaum T, Fischer L, Jahnke K, Herrlinger U, Plasswilm L, Nägele T, Pietsch T, Bamberg M, Weller M. High-dose me — View Citation

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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