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Treatment of Primary CNS Lymphoma ( FTD )

Primary Purpose

Primary CNS Lymphoma (PCNSL)

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HD-MTX-Ara-C regimen
FTD regimen
Sponsored by
Mingzhi Zhang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary CNS Lymphoma (PCNSL) focused on measuring primary CNS lymphoma, chemotherapy, RR, PFS, OS

Eligibility Criteria

14 Years - 69 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age range 14-69 years old;KPS performance status≥60 or ECOG performance status 0-2; Estimated survival time > 3 months; Histological confirmed PCNSL; None of chemotherapy contraindication;At least one measurable lesion according to RECIST;None of other serious diseases;Patients could be followed up;None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments.

volunteers who signed informed consent.

Exclusion Criteria:

Currently undergoing chemotherapy, radiotherapy and targeted therapy (received chemotherapy within 3 weeks, received radiotherapy within 2 weeks, or has not recovered from any previous treatment of acute toxicity);Patients with uncontrolled medical problems (including active infection, uncontrolled diabetes, severe heart, liver, kidney dysfunction and interstitial pneumonia, etc.); Pregnant or lactating women;Serious medical illness likely to interfere with participation;Chemotherapy contraindication such as cachexia; patients with other malignancies previously;Serious infection;The evidence of peripheral nervous disorder or dysphrenia; patients estimated to be unsuitable by investigato

Sites / Locations

  • Oncology Department of The First Affiliated Hospital of Zhengzhou University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

FTD regimen

HD-MTX-Ara-C regimen

Arm Description

FTD regimen(fotemustine, temozolomide and dexamethasone),fotemustine 100mg/m2 d1 ivgtt, temozolomide 150mg/m2 d1-5 po,dexamethasone 40mg d1-5 ivgtt.Continued use to the end of chemotherapy .Every 28 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles.

high-does metrotrexate 3.5g/m2 d1 ivgtt 6h,cytarabine 1g/m2 bid d2-3.Continued use to the end of chemotherapy .Every 21 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles.

Outcomes

Primary Outcome Measures

Progression-free survival
Progression-free survival

Secondary Outcome Measures

response rate
response rate
overall survival
overall survival
median survival time
median survival time

Full Information

First Posted
March 10, 2017
Last Updated
March 2, 2022
Sponsor
Mingzhi Zhang
Collaborators
Zhengzhou University
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1. Study Identification

Unique Protocol Identification Number
NCT05274139
Brief Title
Treatment of Primary CNS Lymphoma ( FTD )
Official Title
The Prospective Study of FTD Program and HD-MTX-Ara-C Program Contrast in the Treatment of PCNSL Lymphoma.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 2, 2017 (Actual)
Primary Completion Date
March 2, 2019 (Actual)
Study Completion Date
March 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mingzhi Zhang
Collaborators
Zhengzhou University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of FTD regiment (fotemustine, temozolomide and dexamethasone ) for patients with primary CNS lymphoma.
Detailed Description
Primary CNS lymphoma (PCNSL) is a rare B-cell variant of non-Hodgkin lymphoma that is confined to the brain, leptomeninges, spinal cord, and eyes. The optimum treatment for patients with PCNSL remains challenging and at present there is no universally accepted therapeutic approach for patients with newly diagnosed disease. The purpose of this study is to evaluate the efficacy and safety of FTD regiment(fotemustine, temozolomide and dexamethasone)contrast with HD-MTX-Ara-C program for patients with primary CNS lymphoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary CNS Lymphoma (PCNSL)
Keywords
primary CNS lymphoma, chemotherapy, RR, PFS, OS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FTD regimen
Arm Type
Experimental
Arm Description
FTD regimen(fotemustine, temozolomide and dexamethasone),fotemustine 100mg/m2 d1 ivgtt, temozolomide 150mg/m2 d1-5 po,dexamethasone 40mg d1-5 ivgtt.Continued use to the end of chemotherapy .Every 28 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles.
Arm Title
HD-MTX-Ara-C regimen
Arm Type
Experimental
Arm Description
high-does metrotrexate 3.5g/m2 d1 ivgtt 6h,cytarabine 1g/m2 bid d2-3.Continued use to the end of chemotherapy .Every 21 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles.
Intervention Type
Drug
Intervention Name(s)
HD-MTX-Ara-C regimen
Other Intervention Name(s)
high-does metrotrexate and cytarabine
Intervention Description
HD-MTX-Ara-C regimen high-does metrotrexate 3.5g/m2 d1 ivgtt 6h,cytarabine 1g/m2 bid d2-3.Continued use to the end of chemotherapy .Every 21 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles
Intervention Type
Drug
Intervention Name(s)
FTD regimen
Other Intervention Name(s)
fotemustine, temozolomide and dexamethasone
Intervention Description
FTD regimen(fotemustine, temozolomide and dexamethasone),fotemustine 100mg/m2 d1 ivgtt,temozolomide 150mg/m2 d1-5 po,dexamethasone 40mg d1-5 ivgtt.Continued use to the end of chemotherapy .Every 28 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles
Primary Outcome Measure Information:
Title
Progression-free survival
Description
Progression-free survival
Time Frame
up to end of follow-up-phase(approximately 24 months)
Secondary Outcome Measure Information:
Title
response rate
Description
response rate
Time Frame
every 6 weeks,up to completion of treatment(approximately 18 weeks )
Title
overall survival
Description
overall survival
Time Frame
up to the date of death (approximately 5 years)
Title
median survival time
Description
median survival time
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age range 14-69 years old;KPS performance status≥60 or ECOG performance status 0-2; Estimated survival time > 3 months; Histological confirmed PCNSL; None of chemotherapy contraindication;At least one measurable lesion according to RECIST;None of other serious diseases;Patients could be followed up;None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments. volunteers who signed informed consent. Exclusion Criteria: Currently undergoing chemotherapy, radiotherapy and targeted therapy (received chemotherapy within 3 weeks, received radiotherapy within 2 weeks, or has not recovered from any previous treatment of acute toxicity);Patients with uncontrolled medical problems (including active infection, uncontrolled diabetes, severe heart, liver, kidney dysfunction and interstitial pneumonia, etc.); Pregnant or lactating women;Serious medical illness likely to interfere with participation;Chemotherapy contraindication such as cachexia; patients with other malignancies previously;Serious infection;The evidence of peripheral nervous disorder or dysphrenia; patients estimated to be unsuitable by investigato
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mingzhi zhang
Organizational Affiliation
The First Affiliated Hospital of Zhengzhou University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oncology Department of The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China

12. IPD Sharing Statement

Learn more about this trial

Treatment of Primary CNS Lymphoma ( FTD )

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