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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018919
Receipt No. R000021856
Scientific Title Phase II trial of biweekly THP-COP therapy for patients with peripheral T-cell lymphomas.
Date of disclosure of the study information 2015/09/05
Last modified on 2018/05/31

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Basic information
Public title Phase II trial of biweekly THP-COP therapy for patients with peripheral T-cell lymphomas.
Acronym Biweekly THP-COP therapy for peripheral T-cell lymphomas
Scientific Title Phase II trial of biweekly THP-COP therapy for patients with peripheral T-cell lymphomas.
Scientific Title:Acronym 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
1st name
Middle name
Last name Naoto Tomita
Organization St. Marianna University School of Medicine
Division name Division of Hematology and Oncology, Department of Internal Medicine
Zip code
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
1st name
Middle name
Last name Naoto Tomita
Organization St. Marianna University School of Medicine
Division name Division of Hematology and Oncology, Department of Internal Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2015 Year 05 Month 26 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000021856

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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