UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018919 |
|---|---|
| Receipt number | 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 20:20:06 |
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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
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
cavalier@ch-yamate.dlenet.com
Sponsor or person
Institute
Kanagawa Clinical Oncology study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021856
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| Registered date | File name |
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| Registered date | File name |
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