W-JHS NHL02 study

JRCT ID: jRCT2071210101

Registered date:24/12/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Peripheral T-cell lymphoma (including extranodal NK/T-cell lymphoma)
• Date of first enrollment: 25/04/2019
• Target sample size: 20
• Study type: Interventional

Intervention(s)

The administration of nivolumab is conducted for 14 days as 1 course and infused 240mg in day 1 of every cycle. The dose of nivolumab is not increase or reduced in this study.
The treatment can be repeated if patients meet all administration criteria of investigational drug and do not meet one of discontinuation criteria. Among all patients receiving investigational drug, the investigators evaluate in the subject corresponding to one of discontinuation criteria of investigational drug (at discontinuation), and patients are shifted for post treatment period.

Outcome(s)

• Primary Outcome: Overall response rate: ORR

Secondary Outcome

[Efficacy]
(1) Progression-free survival (PFS)
(2) Overall survival (OS)
(3) Time to response
(4) Complete response rate (CR)
(5) Comparison of evaluation among Cheson 2007, Cheson LUGANO 2014 and RECIL 2017

[Safety]
(1) Adverse events
(2) Laboratory test
(3) Vital sign, body weight, SpO2
(4) 12-lead electrocardiogram
(5) Chest X-ray
(6) Performance Status (ECOG)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients who was histopathologically diagnosed as the following T cell lymphoma (TCL) (including extranodal NK/T-cell lymphoma)
/Peripheral T-cell lymphoma, not otherwise specified
/Angioimmunoblastic TCL
/ALK positive systemic anaplastic large cell lymphoma (ALCL)
/ALK negative ALCL
/Enteropathy-associated TCL
/Hepatosplenic TCL
/Subcutaneous panniculitis-like TCL
/Extranodal NK/T-cell lymphoma, nasal type
(2) Patients with skin lesions less than 10% of body surface area due to PTCL
(3) Patients with measurable legion.
Meet all following criteria of lesion in patients with peripheral T cell lymphoma.
Lymph node as lymphoma lesion or nodal mass of extranodal organ diagnosed by CT imaging.
Clearly measurable the size in 2 perpendicular dimensions with a CT section image
longer axis >= 1.5cm in CT section image, or if longer axis is <1.5cm, short axis is > 1.0cm.
(4) Patients with more than 2 regimens history by systemic anticancer drug (excluding adrenocortical hormone monotherapy, interferon and retinoid).
(5) Patients who have pre-treatment history by brentuximab vedotin or the drug is inappropriate about CD30-positive systemic anaplastic large cell lymphoma.
(6) Patients who were not provided PD or response (CR or PR) during with systemic antineoplastic treatment, or patients who recurred or aggravated again after systemic antineoplastic treatment.
(7) Patients who can provide tumor tissue sample for central pathological diagnosis.
(8) ECOG PS 0-1
(9) Patients with more than 3 months survival.
(10) Patients with sufficient renal function.
- Creatinine <=1.5x ULN or creatinine clearance >=40 mL/min (actual value or Cockcroft/Gault calculation)
(11) Patients with sufficient hepatic function.
- Total bilirubin <=1.5 x ULN
- Serum albumin >=3.0 g/dL (confirmed 2 weeks later after the administration of albumin preparation)
- AST and ALT <=3 x ULN
(12) Patients with sufficient bone marrow function. (confirmed 2 weeks later after the administration of G-CSF and blood transfusion)
- Neutrophil >=1.5 x 103/microL (1.5 x 109/L)
- Platelets >=7.5 x 104/microL
- Hemoglobin >=8.0g/dL
(13) Female childbearing patients (including patients without menstruation by medical reasons such as chemical menopause) agree to the double contraception at least seven months after informed consent and at least five months after nivolumab administration completion. In addition, patient who can agree to not nursing after informed consent and at least five months after nivolumab administration completion.
(14) Male patients who can agree to the double contraception at least seven months after nivolumab administration start and at least seven months after nivolumab administration completion.
(15) Patients providing written informed consent.

Exclude criteria

(1) Patients with central nervous system lymphoma, intracerebral infiltration or bone marrow infiltration.
(2) Patients with autoimmune disease or history of chronic or recurrent auto immune disease.
(3) Patients with or history interstitial lung disease or pulmonary fibrosis diagnosed by imaging or clinical findings. Patients with radiation pneumonia are eligible if stabilization by fibrosis is confirmed and its recurrence is not concerned.
(4) Patients with diverticulitis or symptomatic gastrointestinal ulcer disease to need treatment.
(5) Patients who received auto-HSCT within 90 days before initiation of nivolumab administration.
(6) Patients who received anticancer therapy such as chemotherapy and immunotherapy within 28 days before initiation of nivolumab administration.
(7) Patients who received mogamulizumab administration within 28 days before initiation of nivolumab administration.
(8) Patients who received other investigational new drugs administration within 28 days or within less than 5 times of elimination half-time (either long one) before initiation of nivolumab administration.
(9) Patients who received radiotherapy within 28 days before initiation of nivolumab administration (as for the local radiotherapy of symptom reduction purpose within 14 days). But chest radiotherapy shall be within 168 days.
(10) Patients who received systemic adrenal cortical hormone more than 10 mg/day doses by prednisolone conversion (except test or temporary use for the purpose of prophylaxis for allergic reaction) or immunosuppressant within 28 days before initiation of nivolumab administration.
(11) Patients who received all other investigational new drug (including the administration by clinical study, combination medicine of investigational new drug, new formulation medicine) within 28 days before initiation of nivolumab administration (in the case of antibody preparation within 90 days)
(12) Patients who received local or surface anesthesia, or operative treatment associated with general anesthesia within 14 days before initiation of nivolumab administration
(13) Patients with active double cancer. However, it is eligible if patients have basal cell cancer completely removed surgically, stage I spinocellular carcinoma, cancer in situ, intramucosal carcinoma or superficial bladder cancer or other cancers has which are not recognized recurrence more than 5years.
(14) Patients with anamnesis of transient cerebral ischemic attack, cerebrovascular attack, thrombosis or the thromboembolism (pulmonary artery embolism or deep vein thrombosis) within 180 days before enrollment to this clinical trial
(15) Patients with remained influence of side effect of pre-treatment or operative treatmen if principal investigator or sub investigator judge that they influence on the safety evaluation of nivolumab.
(16) Patients with the following uncontrollable or severe cardiovascular diseases.
a) Myocardial infarction within 180 days before enrollment to this clinical trial
b) Uncontrollable angina pectoris within 180 days before enrollment to this clinical trial
c) Congestive heart failure of the New York Heart Association (NYHA) classification grade III or IV
d) Uncontrollable hypertension in spite of appropriate treatment (eg. SBP>=150mmHg or DBP >= 90mmHg last more than 24 hours)
e) Arrhythmia to need treatment
(17) Patients with systemic infection need for treatment.
(18) Patients with either HIV antibody positive, HTLV-1 antibody positive, HBs antigen positive or HCV antibody positive. In addition, patient that HBs antigen test is negative, but one of HBs antibody test or HBc antibody test is positive and HBV-DNA assay is more than detection sensitivity.
(19) Patients with history of severe allergic reaction.
(20) Patients with history of organ allotransplantation or allogeneic hematopoietic stem cell transplantation.
(21) Patients with uncontrollable diabetes mellitus.
(22) Pregnant or lactating women or possibility of pregnancy.
(23) Patients whom it is judged to lack in ability for agreement by complication of such as dementia.
(24) Any other patients who are regarded as unsuitable for study enrollment by the investigators

Related Information

• Primary Sponsor: Akashi Koichi
• Secondary ID(s): UMIN000034499