UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015972 |
|---|---|
| Receipt number | R000018576 |
| Scientific Title | A Phase II trial of Dose adjusted EPOCH and Rituximab therapy for newly-diagnosed DLBCL with C-MYC rearrangement |
| Date of disclosure of the study information | 2014/12/16 |
| Last modified on | 2017/06/19 11:56:29 |
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Basic information
Public title
A Phase II trial of Dose adjusted EPOCH and Rituximab therapy for newly-diagnosed DLBCL with C-MYC rearrangement
Acronym
A Phase II trial of DA-EPOCH-R therapy for newly-diagnosed DLBCL with C-MYC rearrangement
Scientific Title
A Phase II trial of Dose adjusted EPOCH and Rituximab therapy for newly-diagnosed DLBCL with C-MYC rearrangement
Scientific Title:Acronym
A Phase II trial of DA-EPOCH-R therapy for newly-diagnosed DLBCL with C-MYC rearrangement
Region
| Japan |
Condition
Condition
C-MYC positive diffuse large B-cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Phase II trial to evaluate efficacy and toxicity of DA-EPOCH-R combined therapy for patients with newly-diagnosed C-MYC positive diffuse large B-cell lymphoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
2-year progression-free survival rate
Key secondary outcomes
Overall response rate, Complete response rate, Overall survival, 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
DA-EPOCH-R
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Histologically confirmed DLBCL, NOS according to the 2008 WHO classification
(2) Confirmed CD20-positive
(3) Confirmed C-MYC-positive by FISH
(4) Tumor cell counts in the peripheral blood within 14 days before resistration are less than 10,000/mm3
(5) Age: 20 to 75 years old
(6) PS (ECOG): 0-2
(7) No clinical symptoms of CNS involvement
(8) Measureable lesion present
(9) No prior chemotherapy, radiotherapy, and antibody therapy for DLBCL
(10) Adequate organ function
(11) Written informed consent
Key exclusion criteria
(1) History of glaucoma
(2) Uncontrollable diabetes mellitus
(3) Uncontrollable hypertension
(4) Coronary artery disease under treatment; cardiomyopathy, heart failure, or arrhythmia treated with anti-arrhythmic
(5) HBs antigen positive
(6) HCV antibody positive
(7) HIV antibody positive
(8) Interstitial pneumonia, pulmonary fibrosis
(9) Severe infection
(10) Liver cirrhosis
(11) Other active malignancies; history of lymphoma, myelodysplastic syndrome, or leukemia
(12) Pregnant, possible pregnant, or breastfeeding woman
(13) Severe psychosis
(14) Under systemic corticosteroid therapy
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoya Nakamura, M.D., Ph.D. |
Organization
Tokai University School of Medicine
Division name
Department of Pathology
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa 259-1143, Japan
TEL
0463-93-1121
naoya@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minoru Kojima, M.D., Ph.D. |
Organization
Tokai University School of Medicine
Division name
Division of Hematology/Oncology
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa 259-1143, Japan
TEL
0463-93-1121
Homepage URL
kojima@tokai-u.jp
Sponsor or person
Institute
Kanagawa Clinical Oncology study Group
Institute
Department
Personal name
Funding Source
Organization
Tokai University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Tokai University School of Medicine
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
東海大学医学部付属病院（神奈川県）
聖マリアンナ医科大学（神奈川県）
神奈川県立がんセンター（神奈川県）
北里大学（神奈川県）
横浜市立大学附属市民総合医療センター（神奈川県）
横浜市立大学附属病院（神奈川県）
東京都健康長寿医療センター（東京都）
川崎市立多摩病院（神奈川県）
海老名総合病院（神奈川県）
秦野赤十字病院（神奈川県）
小澤病院（神奈川県）
横浜市立市民病院（神奈川県）
東京医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 16 | 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
Completed
Date of protocol fixation
| 2014 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 16 | Day |
Last modified on
| 2017 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018576
