Treatment of Primary CNS Lymphoma - Clinical Trial for Primary CNS Lymphoma (PCNSL) | NCT01960192

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Primary Purpose

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

HD-MTX-Ara-C regimen

FVD regimen

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 - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:Age range 14-60 years old; ECOG performance status 0-2; Estimated survival time > 3 months Histological confirmed PCNSL None of chemotherapy or radiotherapy has been previously used None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤ 1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L, serum plasminogen is normal (Inclusion Criteria of 1,3,6 groups ) At least one measurable lesion None of other serious diseases, cardiopulmonary function is normal Pregnancy test of women at reproductive age must be negative 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:Disagreement on blood sample collection Patients allergic of any of drug in this regimen or with metabolic disorder Pregnant or lactating women Serious medical illness likely to interfere with participation Serious infection Primitive or secondary tumors of central nervous system Chemotherapy or radiotherapy contraindication The evidence of peripheral nervous disorder or dysphrenia patients participating in other clinical trials patients taking other antitumor drugs patients estimated to be unsuitable by investigato

-

Sites / Locations

Oncology Department of The First Affiliated Hospital of Zhengzhou UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

FVD regimen

HD-MTX-Ara-C regimen

Arm Description

FVD regimen(fotemustine, teniposide and dexamethasone),fotemustine 100mg/m2 d1 ivgtt,teniposide 60mg/m2 d2-4 ivgtt,dexamethasone 40mg d1-5 ivgtt.Continued use to the end of chemotherapy .Every 21 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

Secondary Outcome Measures

response rate

overall survival

median survival time

Full Information

NCT ID

NCT01960192

First Posted

October 8, 2013

Last Updated

July 19, 2015

Sponsor

Mingzhi Zhang

Collaborators

Zhengzhou University

1. Study Identification

Unique Protocol Identification Number

NCT01960192

Brief Title

Treatment of Primary CNS Lymphoma

Acronym

FVD

Official Title

The Prospective Study of FVD Program and HD-MTX-Ara-C Program Contrast in the Treatment of PCNSL Lymphoma.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Unknown status

Study Start Date

June 2012 (undefined)

Primary Completion Date

June 2016 (Anticipated)

Study Completion Date

June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mingzhi Zhang

Collaborators

Zhengzhou University

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of FVD regiment (fotemustine, teniposide 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 FVD regiment(fotemustine, teniposide 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 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FVD regimen

Arm Type

Experimental

Arm Description

FVD regimen(fotemustine, teniposide and dexamethasone),fotemustine 100mg/m2 d1 ivgtt,teniposide 60mg/m2 d2-4 ivgtt,dexamethasone 40mg d1-5 ivgtt.Continued use to the end of chemotherapy .Every 21 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

Intervention 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)

FVD regimen

Intervention Description

FVD regimen(fotemustine, teniposide and dexamethasone),fotemustine 100mg/m2 d1 ivgtt,teniposide 60mg/m2 d2-4 ivgtt,dexamethasone 40mg d1-5 ivgtt.Continued use to the end of chemotherapy .Every 21 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles

Primary Outcome Measure Information:

Title

Progression-free survival

Time Frame

up to end of follow-up-phase (approximately 24 months)

Secondary Outcome Measure Information:

Title

response rate

Time Frame

every 6 weeks,up to completion of treatment(approximately 18 weeks )

Title

overall survival

Time Frame

up to the date of death (approximately 5 years)

Title

median survival time

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:Age range 14-60 years old; ECOG performance status 0-2; Estimated survival time > 3 months Histological confirmed PCNSL None of chemotherapy or radiotherapy has been previously used None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤ 1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L, serum plasminogen is normal (Inclusion Criteria of 1,3,6 groups ) At least one measurable lesion None of other serious diseases, cardiopulmonary function is normal Pregnancy test of women at reproductive age must be negative 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:Disagreement on blood sample collection Patients allergic of any of drug in this regimen or with metabolic disorder Pregnant or lactating women Serious medical illness likely to interfere with participation Serious infection Primitive or secondary tumors of central nervous system Chemotherapy or radiotherapy contraindication The evidence of peripheral nervous disorder or dysphrenia patients participating in other clinical trials patients taking other antitumor drugs patients estimated to be unsuitable by investigato -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mingzhi zhang, Pro，Dr

Phone

13838565629

Email

Mingzhi_zhang@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mingzhi Zhang, Pro,Dr

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

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mingzhi Zhang, Pro,Dr

Phone

13838565629

Email

mingzhi_zhang@126.com

Treatment of Primary CNS Lymphoma (FVD)

Primary CNS Lymphoma (PCNSL)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial