Atezolixumab in patients with relapsed/refractory NK/T-cell lymphoma
- Conditions
- extranodal NK/T-cell lymphoma, nasal type (ENKL)ENKLD054391ENK
- Registration Number
- JPRN-jRCT2031190177
- Lead Sponsor
- Izutsu Koji
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
1) Histologically diagnosed as extranodal NK/T-cell lymphoma, nasal type (ENKL) in WHO classification
2) Recurrence or treatment resistance
3) Age at the time of registration is 12 years or older
4) ECOG performance status (PS) is 0-2
5) In whole body CT or MRI scanning within 14 days prior to registration, one or more measurable lesions
6) One or more prior chemotherapy for ENKL
7) Patients with a history of treatment with SMILE regimen (dexamethasone + methotrexate + ifosfamide + L-asparaginase + etoposide), or patients who do not have an indication of SMILE regimen
8) No history of allogeneic hematopoietic stem cell transplantation within 6 months prior to registration
9) No central nervous system invasion with symptoms
10) Not receiving cancer drug therapy within 14 days prior to registration (but allows the administration of corticosteroid drugs which is equivalent to 60 mg/day or less prednisolone for relieving symptoms caused by tumors)
11) Not receiving radiation therapy within 14 days prior to registration
12) Clinical tests conducted within 14 days prior to registration meet the followings:
A) Neutrophil count >= 1500 /mm(3) (allowing the use of G-CSF as supportive therapy)
B) Platelet count >= 7.5x10(4) /mm(3) (allow platelet transfusion as supportive therapy)
C) Hemoglobin >= 8.0 g/dL (allowing red blood cell transfusion as a supportive therapy)
D) AST <= 150 U/L
E) ALT <= 210 U/L (male) / <= 115 U/L (female)
F) Creatinine <=1.5 mg/dL or creatinine clearance >=45 mL/min or higher (measured with 24h urine collection or estimated by Cockcroft/Gault)
13) Transdermal oxygen saturation (SpO2) is 92% or more under room air within 14 days prior to registration
14) For women who is capable to be pregnant, they have agreed to contraception after obtaining consent until at least five months after the final administration of the investigational drug. For lactating patients, it has been agreed not to breastfeed after the first administration of the study drug until at least 5 months after the final administration of the investigational drug.
15) Written consent has been obtained by the patient himself or his/her substitute
1) Have another active malignancy which needs treatment
2) Have an infection that requires systemic treatment (but allows preventive administration of antibiotic/antiviral/antifungal drugs)
3) Patients with interstitial pulmonary disease or pulmonary fibrosis diagnosed by imaging or clinical findings
4) Have a history of autoimmune diseases excepting for the following:
A) Patients with autoimmune-related hypothyroidism who use thyroid hormone drugs
B) Patients with type 1 diabetes controlled by insulin
C) Eczema, psoriasis, chronic simple lichen scleromy or vitiligo vulgaris, which symptoms are limited only to the skin
5) Having a graft-versus-host disease (GVHD) requiring immunosuppressive drugs
6) Patients with active tuberculosis
7) Significant cardiovascular disease (history of the following diseases within 3 months prior to registration); New York Heart Association Class II or higher heart failure, myocardial infarction, cerebral infarction/cerebral hemorrhage, arrhythmia/angina difficult to be managed with medication)
8) Prior administration of immune checkpoint inhibitors such as CD137 agonists, anti-CTLA-4, anti-PD-1 or anti-PD-L1 antibody drugs
9) Have history of allergies to any chimeric antibodies, humanized antibodies, fusion proteins, Chinese hamster ovarian cell-derived products or any components of Atezolizumab formulations
10) HIV antibody, HBs antigen, or HCV antibody is positive (but does not exclude patients whose HCV-RNA is not detected, even if the HCV antibody is positive)
11) In HBs antigen-negative patients, HBs antibody or HBc antibody is positive with measurable HBV-DNA level
12) Pregnant, lactating, and possibly pregnant women
13) Patients who is difficult to participate because of mental illness or mental symptoms that interfere with daily life
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method objective response rate (indipendent review)
- Secondary Outcome Measures
Name Time Method complete response rate, metabolic complete response rate at end of cycle 4, objective response rate, progression free survival, overall survival, duration of response, time to treatment failure, toxicity