search
Back to results

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

Primary Purpose

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

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
thiotepa combined with pomalidomide
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed or Refractory (R/R) Primary Central Nervous System Lymphoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jiangsu Province People's Hospital.Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

thiotepa+pomalidomide

Arm 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.

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR)
The proportion of subjects who achieves a best overall response of CR or PR.
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

Secondary Outcome Measures

2-year Progression-free Survival (PFS) rate
The proportion of patients who did not experience disease progression at 2 years.
2-year Overall Survival(OS)rate
The proportion of patients who survived at 2 years.
Duration of Response(DOR)
From the date that CR or PR are first occurred to the date of objective disease progression or death, whichever occurs first.

Full Information

First Posted
June 27, 2023
Last Updated
June 27, 2023
Sponsor
The First Affiliated Hospital with Nanjing Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT05931328
Brief Title
The Study of the Combination of Thiotepa and Pomalidomide for the Treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma Patients.
Official Title
A Single-arm, Prospective, Multicenter Clinical Trial of the Combination of Thiotepa and Pomalidomide for the Treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory (R/R) Primary Central Nervous System Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
thiotepa+pomalidomide
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
thiotepa combined with pomalidomide
Intervention 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.
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
The proportion of subjects who achieves a best overall response of CR or PR.
Time Frame
Baseline up to 2 years.
Title
Adverse event rate
Description
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Time Frame
Baseline up to 3 years.
Secondary Outcome Measure Information:
Title
2-year Progression-free Survival (PFS) rate
Description
The proportion of patients who did not experience disease progression at 2 years.
Time Frame
Baseline up to 2 years.
Title
2-year Overall Survival(OS)rate
Description
The proportion of patients who survived at 2 years.
Time Frame
Baseline up to 3 years.
Title
Duration of Response(DOR)
Description
From the date that CR or PR are first occurred to the date of objective disease progression or death, whichever occurs first.
Time Frame
Baseline up to 2 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Xu, PhD
Phone
13951699449
Email
xuwei10000@hotmail.com
Facility Information:
Facility Name
Jiangsu Province People's Hospital.
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiazhu Wu, phD
Phone
13851795723
Email
wujiazhu09@sina.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs