Actively Recruiting
The Study of the Combination of Thiotepa and Pomalidomide for the Treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma Patients.
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2023-07-05
28
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this study is to evaluate the efficacy and safety of the combination of thiotepa and pomalidomide in the treatment of relapsed/refractory (R/R) primary central nervous system lymphoma (PCNSL).
CONDITIONS
Official Title
The Study of the Combination of Thiotepa and Pomalidomide for the Treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed primary central nervous system lymphoma diagnosed by 2016 WHO criteria
- Previously treated with at least one chemotherapy course and disease progression or recurrence
- Aged 18 to 75 years
- ECOG performance score of 0 to 4
- Expected survival time of more than 3 months
- At least one measurable lesion on PET/CT and head MRI within 28 days before enrollment or abnormal cerebrospinal fluid or ocular examination confirming lesions
- Adequate liver function (total bilirubin 1.5 times upper limit of normal, ALT and AST 2.5 times upper limit of normal)
- Adequate kidney function (creatinine 1 times upper limit of normal or creatinine clearance rate 90 mL/min)
- Cardiac function grade III or less by NYHA standards and ejection fraction 50%
- Coagulation function within specified limits (INR 1.5 ULN, APTT 10s, PT 3s)
- Normal thyroid function or no symptoms with abnormal TSH but normal T3/T4
- Women of childbearing age must use contraception or have a negative pregnancy test before and during the study and for 90 days after last dose
- Men must use contraception during the study and for 90 days after last dose or have had surgical sterilization
- Voluntary informed consent, good compliance, and willingness to cooperate with follow-up
You will not qualify if you...
- Pregnant or lactating women
- Involvement of sites outside the central nervous system
- Bone marrow failure (ANC <1.5 x 10^9/L, platelets <75 x 10^9/L, hemoglobin <70 g/L)
- Other malignant tumors except lymphoma unless disease-free for 5 years after curative treatment or treated basal cell carcinoma or cervical intraepithelial neoplasia with no disease evidence
- Known allergy to investigational drug components
- History of allogeneic organ or hematopoietic stem cell transplantation
- Receiving other systemic anti-tumor therapy during the study
- HIV positive, active hepatitis, or uncontrolled infections
- History of clear neurological or psychiatric disorders
- Drug abuse or medical, psychological, or social conditions interfering with study participation or evaluation
- Investigator deems participant unsuitable for enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Jiangsu Province People's Hospital.
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
W
Wei Xu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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