UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II trial of biweekly THP-COP therapy for patients with peripheral T-cell lymphomas.
Title of the study (Brief title)	Biweekly THP-COP therapy for peripheral T-cell lymphomas
Region	Japan

Condition
Condition	Peripheral T-cell lymphomas (PTCL,nos, AITL, ALK-negative ALCL)
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Phase II trial to evaluate the efficacy and toxicity of biweekly THP-COP therapy for patients with newly-diagnosed peripheral T-cell lymphomas
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	3-year progression-free survival rate
Key secondary outcomes	Complete remission rate, Overall survival rate, Toxicity

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Biweekly THP-COP
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	15 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Histologically confirmed PTCL,nos, AITL, or ALCL, ALK-negative according to the 2008 WHO classification (2) Age: 15 to 70 years old (3) PS (ECOG): 0-2 (4) No clinical symptoms of CNS involvement (lumbar puncture/head imaging study are not mandatory) (5) Measureable lesion present (6) No prior chemotherapy or radiotherapy for PTCLs. Prior steroid monotherapy for any disease is eligible. Patients with steroid administration for disease except for lymphoma must stop steroid at registration. Short-term steroid administration for lymphoma-associated symptoms such as B symptoms is eligible. (7) The name of disease and prognosis are informed. (8) 1. AST equal or lower than 2.5 UNL 2. ALT equal or lower than 2.5 UNL 3. T-bil equal or lower than 2.0 mg/dL 4. Cr equal or lower than 1.5 mg/dL 5. WBC equal or higher than 3,500 /mm3 6. Hb equal or higher than 10 g/dl 7. Plt equal or higher than 100,000 /mm3 Cases not meeting for above criteria because of lymphoma involvement are eligible. (9) Ejection fraction of left ventricle equal or higher than 50% by echocardiogram. (10) Without arrhythmia or abnormal electrocardiogram needing therapeutic intervention (11) PaO2 equal or higher than 60 mmHg (12) Written informed consent of patient (and parents in minor)
Key exclusion criteria	(1) Severe infection, active tuberculosis, uncontrollable diabetes mellitus under insulin treatment, or liver cirrhosis (2) Other active malignancy (except for in situ carcinoma in uterine cervix or basal cell carcinoma) (3) CNS involvement (4) Pregnant or breastfeeding women (5) Severe psychosis (6) HBs antigen positive (7) HBc antibody positive or HBs antibody positive, with HBV-DNA positive (8) HIV antibody positive or HTLV-1 antibody positive (9) Patients with difficult situation for study such as high-risk of gastrointestinal perforation/bleeding or surgical indication
Target sample size	40

Research contact person
Name of lead principal investigator	Naoto Tomita
Organization	St. Marianna University School of Medicine
Division name	Division of Hematology and Oncology, Department of Internal Medicine
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki 216-8511, Japan
TEL	044-977-8111
Email	cavalier@ch-yamate.dlenet.com

Public contact
Name of contact person	Naoto Tomita
Organization	St. Marianna University School of Medicine
Division name	Division of Hematology and Oncology, Department of Internal Medicine
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki 216-8511, Japan
TEL	044-977-8111
Homepage URL
Email	cavalier@ch-yamate.dlenet.com

Sponsor
Institute	Kanagawa Clinical Oncology study Group
Institute
Department

Funding Source
Organization	St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	横浜市立大学大学院医学研究科病態免疫制御内科学　　 東海大学医学部医学科内科学系血液腫瘍内科学　　　　 聖マリアンナ医科大学血液腫瘍内科　　　　　　　　　 北里大学医学部血液内科学　　　　　　　　　　　　　 横浜市立大学附属市民総合医療センター血液内科　　　 神奈川県立がんセンター腫瘍内科　　　 藤沢市民病院血液膠原病科　　　　　　　　　　　　　 横須賀市立市民病院血液科　　　　　　　　　　　　　 大和市立病院血液腫瘍内科　　　　　　　　　　　　　 済生会横浜市南部病院血液内科　　　　　　　　　　　 静岡赤十字病院血液内科　　　　　　　　　　　　　　 横浜市民病院血液内科 海老名総合病院血液内科 聖マリアンナ医科大学横浜市西部病院

Other administrative information
Date of disclosure of the study information	2015 Year 09 Month 05 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 05 Month 26 Day
Anticipated trial start date	2015 Year 06 Month 01 Day
Last follow-up date	2023 Year 05 Month 31 Day
Date of closure to data entry	2023 Year 05 Month 31 Day
Date trial data considered complete	2023 Year 05 Month 31 Day
Date analysis concluded	2023 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 09 Month 05 Day
Last modified on	2018 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021856