NHOH-PTCL-GDPR

JRCT ID: jRCTs031180445

Registered date:29/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: peripheral T-cell lymphoma
• Date of first enrollment: 29/03/2019
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Gemcitabine, dexamethasone, and cisplatin (GDP) therapy will administered every 3 weeks, from 2 to 4 cycles, and complete response / partial response / stable disease is found in the judgment after GDP. Romidepsin will be administered every 4 weeks until 12 cycles.

Outcome(s)

• Primary Outcome: The primary endpoint will be a 2-year progression-free survival rate.
• Secondary Outcome: The secondary endpoints are as follows: GDP+romidepsin therapy complete response (CR) rate; response (CR+ partial response (PR)) rate; adverse events; OS; time to achieve a response (defined as the period from the registration day until the day on which a response (PR and higher) is first confirmed); the best response to GDP therapy; the best response to romidepsin therapy; the best response to treatment according to disease risks (e.g. international prognostic index, prognostic index for T-cell lymphoma); quality of life (QOL); inpatient-outpatient period; necessary expenses; and pathology centered diagnosis.

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) The patient is 65 years old or older at the time of registration.
2) The patient is diagnosed with peripheral T-cell lymphoma (PTCL-NOS or AITL according to the 2016 WHO classification), has previously undergone more than one treatment regimen, are not eligible for autologous and allogeneic stem-cell transplantation, and their condition has relapsed or is refractory.
3) The patient has a lesion that is measurable.
4) The patient's Eastern Cooperative Oncology Group Performance Status at the time of registration is 0-2.
This can be after a previous PSL dose (approx. one-week PSL administration is permissible).
5) The patient satisfies the following criteria and the major organ functions have been maintained.
5-a) The patient has a neutrophil count of 1,000/mm^3L and above.
5-b) The patient has a platelet count of 50,000/mm^3L and above.
5-c) The patient's cardiac function has an ejection fraction of over 50% (echocardiogram or myocardial scintigraphy).
5-d) The patient's arterial blood gas analysis shows a PaO2 of over 60 mmHg, or the percutaneous oxygen saturation measurement shows an SpO2 of over 93% (room air).
5-E) The patient's serum AST or ATL is less than 5 times the maximum value of the facility standard.
5-F) The patient's creatinine clearance is over 30 ml/min (Cockcroft-Gault).
6) The patient has received a notification and the content of the trial has been adequately explained to the patient by the facility investigator (assigned) using the designated consent form and explanatory materials, and the patient has provided written informed consent of voluntary participation in the trial.

Exclude criteria

1) The patient has been clinically diagnosed with testis or central nervous system (brain, spinal cord, medullary cavity).
(An examination of the cerebrospinal fluid or an MRI of the brain is not mandatory)
2) The patient has uncontrolled hepatic, renal, cardiac, or pulmonary dysfunction, diabetes, or hypertension.
3) The patient has interstitial pneumonia or pulmonary fibrosis. (If either is determined by a plain X-ray image of the chest, the patient shall not be able to register. Mild cases indicated for the first time on a chest CT scan shall not be excluded. Patients whose lungs have been previously exposed to radiation shall be excluded, as they are at a high risk of developing interstitial pneumonia.)
4) The patient presents with a QTc interval that measures over 500 ms on an electrocardiogram.
5) The patient has a tubercular disease, herpetic simplex keratitis, systemic mycoses, or any other active infection.
6) The patient has had, within the past 6 months, an acute myocardial infarction, deep vein thrombosis, or a pulmonary embolism.
7) The patient has an active and advanced stage double cancer (synchronous double cancer and metachronous double cancer with a disease-free interval of less than 5 years. However, lesions that correspond to carcinoma in situ of the uterine cervix, the stomach, or the colon that are deemed to have been cured by local treatment are not considered as active double cancers).
8) The patient is HBs antigen positive, HCV antigen positive, HTLV-1 antigen positive, or HIV antigen positive. (HBs antibody and HBc antibody positive patients shall not be excluded. If HBV-DNA is detected, the patient shall be excluded. An HIV antibody test is not mandatory).
9) The patient has a history of severe drug hypersensitivity.
10) The patient lacks the ability to give consent, suffering from symptoms such as dementia.
11) The patient has undergone local radiotherapy less than 2 weeks prior to the trial.
12) The representative doctor of the facility or investigator deems the patient to be unfit to participate in the trial.

Related Information

• Primary Sponsor: IWASAKI Hiromi