Clinical trial NCT05274139: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary CNS Lymphoma (PCNSL)
Keywords: primary CNS lymphoma
chemotherapy
RR
PFS
OS
Lead sponsor: Zhengzhou University
Sponsor class: OTHER
Collaborators: name: Zhengzhou University
First posted: 2022-03-10
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Maximum age (years): 69
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression-free survival
timeFrame: up to end of follow-up-phase(approximately 24 months)
Secondary outcomes:
measure: response rate
timeFrame: every 6 weeks,up to completion of treatment(approximately 18 weeks )
measure: overall survival
timeFrame: up to the date of death (approximately 5 years)
measure: median survival time
timeFrame: 24 months
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Oncology Department of The First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Mingzhi zhang
role: PRINCIPAL_INVESTIGATOR
References: