A Phase II Trail of Chidamide ,Rituximab and Methotrexate in Lymphoma Patients (C-R-HDMTX)

August 14, 2020 updated by: Fangfang Lv, MD, Fudan University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

51

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fangfang Lv
  • Phone Number: +86-18018312613
  • Email: lvff80@163.com

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CR rate
Time Frame: up to 18 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Fangfang Lv, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2020

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

August 30, 2023

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 14, 2020

First Posted (Actual)

August 18, 2020

Study Record Updates

Last Update Posted (Actual)

August 18, 2020

Last Update Submitted That Met QC Criteria

August 14, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-R-HDMTX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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