Chemotherapy-free salvage therapy with rituximab, lenalidomide, and poseltinib for the treatment of relapsed or refractory primary central nervous system lymphoma
- Conditions
- Neoplasms
- Registration Number
- KCT0008105
- Lead Sponsor
- Chonnam National University Hospital Hwasun Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 29
1) Subjects who were histopathologically diagnosed with CD20-positive primary central nervous system lymphoma and whose disease progression or treatment failure was confirmed after chemotherapy or radiation therapy or autologous transplant for the purpose of inducing remission
? However, cases where primary central nervous system lymphoma was diagnosed with imaging only and treatment was started were excluded.
? Cases in which autologous transplantation is planned after salvage cytotoxic anti-cancer treatment are excluded.
? Subjects diagnosed with CD20-negative primary central nervous system lymphoma were also excluded.
2) Subjects with at least one measurable and evaluable lesion with a size of 1.5 cm or more in Brain MRI or (or) when leptomeningeal seeding is confirmed in cerebrospinal fluid examination
3) Proper functioning of the bone marrow, kidneys and liver
(Inspection values after correction through blood transfusion and hematopoiesis promoter are also possible.)
? Absolute neutrophil count =1000/µL
? Platelets = 50,000/µL
? Erythrocytes = 9.0 g/dL
? Serum calcium = 12.0 mg/dL
? Serum creatinine = 1.5 x upper limit of normal
? (Creatinine clearance = 50 mL/min (based on Cockcroft-Gault formula)
? AST/ALT = 2.5 X upper limit of normal
? Total bilirubin =1.5 x upper limit of normal
4) Healthy hepatitis B carriers can participate only if they can receive prophylactic antiviral treatment at the same time.
5) ECOG PS 0-2
6) Those who can take oral medication
7) Non-fertile female subjects who have undergone natural menopause or hysterectomy or bilateral oophorectomy for at least 24 months prior to study enrollment
8) Male subjects who are able to comply with the following even if they are surgically sterile (i.e., have undergone vasectomy)
? Males must use effective contraception during the clinical trial participation period and for 4 weeks after completion of the medication; The partner is a woman of childbearing potential and is not using adequate contraception.
? Even if male subjects have undergone vasectomy, they must agree to use condoms while receiving the investigational drug, while temporarily discontinuing the dose, and for 4 weeks after completing the administration.
? Semen should not be donated during the administration of investigational drugs and for 4 weeks after discontinuation of administration.
9) The lenalidomide risk management plan must be followed (Appendixes 5, 6, 7).
10) Subjects who can use stored tumor tissue samples for target sequencing
1) First diagnosed primary central nervous system lymphoma and metastatic central nervous system lymphoma (with systemic disease: Secondary CNS lymphoma)
2) Symptomatic or uncontrolled angina and congestive heart failure, arrhythmia requiring medication (however, it is allowed if controlled by medication), clinically significant myocardial infarction that occurred within 6 months prior to participation in this clinical trial Subjects who are predicted to be at significant risk due to
3) Occurrence of thrombosis or embolism within 6 months before the start of screening
4) Serious gastrointestinal bleeding greater than or equal to grade 2 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 within 30 days prior to the start of screening.
5) In case of ongoing infection exceeding grade 2 according to the Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version within 30 days before the start of screening
6) Chronic hepatitis accompanied by liver cirrhosis and HBV reactivation (However, even if hepatitis B surface antigen is positive, if it is observed asymptomatic and does not require treatment, it can be registered at the discretion of the researcher)
7) Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at the time of screening (HCV RNA positive if HBV surface antigen positive or anti-HCV antibody positive in screening test)
8) Those who cannot take oral medication
9) Subjects with a history of malignant tumors other than the target disease, except for the following cases
? If you have not received treatment for the tumor for at least 5 years or are disease-free
? At least 1 year has passed since complete resection of basal cell carcinoma/squamous cell carcinoma or successful treatment of cervical carcinoma in situ
10) Women of childbearing age are excluded.
? Women who are pregnant, lactating or planning to become pregnant
? If you have not undergone hysterectomy or bilateral oophorectomy, or have not reached natural menopause (amenorrhea after chemotherapy is not excluded from fertility) for at least 24 consecutive months. (i.e. menstruated at any time within the previous 24 months).
11) Subjects with hypersensitivity reactions to the components of the provided clinical trial drugs (rituximab, lenalidomide, poseltinib) (e.g., angioedema, Stevens-Jones syndrome, toxic epidermal necrolysis, eosinophilia and systemic symptoms Subjects with accompanying drug reactions (DRESS syndrome)
12) Subjects with genetic problems such as galactose intolerance, Lapp lactase difeciency or glucose-galactose malabsorption
13) Substance abuse, medical, mental or social illness that may interfere with the subject's participation in the clinical trial or evaluation of the clinical trial results.
14) Subjects who cannot understand or comply with the instructions and requirements of clinical trials or who have a history of non-compliance with medical therapy
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To confirm the efficacy and safety of a combination therapy of three drugs, rituximab, lenalidomide, and poseltinib (BTKi), for relapsed and refractory lymphocytic malignancies of the central nervous system.
- Secondary Outcome Measures
Name Time Method safety