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Completed

NCT Number: NCT05274139

Treatment of Primary CNS Lymphoma ( FTD )

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.

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Key information

Age range

14 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oncology Department of The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HD-MTX-Ara-C regimen

Drug

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

Other names: high-does metrotrexate and cytarabine

FTD regimen

Drug

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

Other names: fotemustine, temozolomide and dexamethasone

Primary outcomes

  1. Progression-free survival

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

    Progression-free survival

Secondary outcomes

  1. response rate

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

    response rate

  2. overall survival

    Time frame: up to the date of death (approximately 5 years)

    overall survival

  3. median survival time

    Time frame: 24 months

    median survival time

Sponsors and collaborators

Lead sponsor

Mingzhi Zhang

Other

Collaborators

  • Zhengzhou University

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 10, 2022
Registry last updated
Mar 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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