NCT05274139

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2019

Completed
3 years until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

March 10, 2017

Last Update Submit

March 2, 2022

Conditions

Primary CNS Lymphoma (PCNSL)

Keywords

primary CNS lymphomachemotherapyRRPFSOS

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    Progression-free survival

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

Secondary Outcomes (3)

  • response rate

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

  • overall survival

    up to the date of death (approximately 5 years)

  • median survival time

    24 months

Study Arms (2)

FTD regimen

EXPERIMENTAL

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.

Drug: FTD regimen

HD-MTX-Ara-C regimen

EXPERIMENTAL

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.

Drug: HD-MTX-Ara-C regimen

Interventions

HD-MTX-Ara-C regimenDRUG

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

Also known as: high-does metrotrexate and cytarabine
HD-MTX-Ara-C regimen
FTD regimenDRUG

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

Also known as: fotemustine, temozolomide and dexamethasone
FTD regimen

Eligibility Criteria

Age14 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncology Department of The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

MeSH Terms

Interventions

CytarabinefotemustineTemozolomideDexamethasone

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDacarbazineTriazenesOrganic ChemicalsImidazolesAzolesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Mingzhi zhang

    The First Affiliated Hospital of Zhengzhou University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
the director of oncology department of the first affiliated hospital

Study Record Dates

First Submitted

March 10, 2017

First Posted

March 10, 2022

Study Start

March 2, 2017

Primary Completion

March 2, 2019

Study Completion

March 2, 2019

Last Updated

March 10, 2022

Record last verified: 2022-03

Locations

CN(1)