The Study of the Combination of Thiotepa and Pomalidomide for the Treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma Patients.

Trial Title: The Study of the Combination of Thiotepa and Pomalidomide for the Treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma Patients.

NCT ID: NCT05931328

Condition: Relapsed or Refractory (R/R) Primary Central Nervous System Lymphoma

Conditions: Official terms:
Lymphoma
Pomalidomide
Thiotepa

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: thiotepa combined with pomalidomide
Description: thiotepa combined with pomalidomide: thiotepa 30mg/m2,intravenously guttae, on day 1; pomalidomide 12mg orally daily for 2 weeks. A chemotherapy cycle lasts for 3 weeks.
Arm group label: thiotepa+pomalidomide

Summary: 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).

Criteria for eligibility:
Criteria:
Inclusion Criteria: Pathologically confirmed PCNSL, diagnosed according to the 2016 WHO diagnostic criteria. Previously treated with at least one course of chemotherapy, with disease progression or recurrence. Aged 18 to 75 years old; ECOG PS score of 0 to 4 points; Expected survival time of more than 3 months; A whole-body PET/CT and head MR (plain scan + enhancement) performed within 28 days before study enrollment should show at least one measurable lesion in two perpendicular directions (based on the 2014 Lugano criteria), or abnormal findings in cerebrospinal fluid examination (including cerebrospinal fluid cells, NGS), or ocular examination confirming lesions in the retina or vitreous body; Adequate organ function, defined as follows: Liver function: serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Renal function: serum creatinine (Cr) ≤ 1 × ULN or creatinine clearance rate (CCR) ≥ 90 mL/min; Cardiac function: cardiac function grade of III or less (NYHA standard); echocardiography shows an ejection fraction of ≥50%; Coagulation function: international normalized ratio (INR) ≤ 1.5 × ULN, activated partial thromboplastin time (APTT) ≤ 10s, and prothrombin time (PT) ≤ 3s; Thyroid function: baseline thyroid-stimulating hormone (TSH) level is normal or baseline TSH is abnormal, but T3/T4 is normal and there are no symptoms; Women of childbearing age must take contraceptive measures or undergo a pregnancy test with a negative result before enrollment, and take contraceptive measures during the trial and within 90 days after the last dose of the drug; for men, contraceptive measures must be taken during the trial and within 90 days after the last dose of the drug, or they must have undergone surgical sterilization; The subject voluntarily agrees to participate in the study, signs an informed consent form, has good compliance, and cooperates with follow-up. Exclusion Criteria: Pregnant or lactating women; Patients with involvement of sites other than the central nervous system; Patients with bone marrow failure, specifically defined as absolute neutrophil count (ANC) <1.5 x 109/L, platelets <75 x 109/L, and hemoglobin <70 g/L; Patients diagnosed with malignant tumors other than lymphoma or currently undergoing treatment, with the following exceptions: - Patients who have received curative treatment and have not had any known active malignant tumors for ≥5 years prior to enrollment; ② Patients with adequately treated basal cell carcinoma of the skin without evidence of disease (excluding melanoma); ③ Patients with adequately treated cervical intraepithelial neoplasia without evidence of disease. Known allergy to any component of the investigational drug; Patients who have undergone allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; Patients who may receive other systemic anti-tumor therapy during the study period; Patients with human immunodeficiency virus (HIV) antibodies, active hepatitis, or other uncontrolled infectious diseases; Patients with a history of clear neurological or psychiatric disorders; Patients who may interfere with the participation of the subject in the study or the evaluation of study results due to drug abuse, medical, psychological or social conditions; Patients deemed unsuitable for enrollment by the investigator.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Jiangsu Province People's Hospital.

Address:
City: Nanjing
Country: China

Status: Recruiting

Contact:
Last name: Jiazhu Wu, phD

Phone: 13851795723
Email: wujiazhu09@sina.com

Start date: October 15, 2022

Completion date: October 2026

Lead sponsor:
Agency: The First Affiliated Hospital with Nanjing Medical University
Agency class: Other

Source: The First Affiliated Hospital with Nanjing Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05931328