UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008507 |
|---|---|
| Receipt number | R000009998 |
| Scientific Title | A Phase II trial of DA-EPOCH And Rituximab with HD-MTX therapy for newly-diagnosed DLBCL with CD5 expression (PEARL5 study) |
| Date of disclosure of the study information | 2012/07/25 |
| Last modified on | 2021/07/30 09:03:09 |
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Basic information
Public title
A Phase II trial of DA-EPOCH And Rituximab with HD-MTX therapy
for newly-diagnosed DLBCL with CD5 expression (PEARL5 study)
Acronym
A Phase II trial of DA-EPOCH And Rituximab with HD-MTX therapy
for newly-diagnosed DLBCL with CD5 expression (PEARL5 study)
Scientific Title
A Phase II trial of DA-EPOCH And Rituximab with HD-MTX therapy
for newly-diagnosed DLBCL with CD5 expression (PEARL5 study)
Scientific Title:Acronym
A Phase II trial of DA-EPOCH And Rituximab with HD-MTX therapy
for newly-diagnosed DLBCL with CD5 expression (PEARL5 study)
Region
| Japan |
Condition
Condition
CD5-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 with high-dose (HD) MTX therapy for patients with newly-diagnosed, stage II-IV CD5-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
Complete response rate, overall response rate, overall survival, 2-year CNS recurrence rate, adverse events
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
Four cycles of DA-EPOCH-R followed by 2 cycles of HD-MTX(3.5 g/m2 IV, day1, q2w) and additional 4 cycles of 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 CD5-positive diffuse large B-cell lymphoma according to the 2008 WHO classification
(2) Confirmed CD20-positive and CD5-positive by immunohistochemistry and/or flow cytometry
(3) Ann Arbor stage: II, III, or IV
(4) Lymphoma cell count in peripheral blood 14 days before registration >= 10,000/mm3
(5) Age: 20 to 75 years old
(6) PS (ECOG): 0-3
(7) No clinical symptoms of CNS involvement
(8) Measureable lesion present
(9) No prior chemotherapy, radiotherapy, and antibody therapy
(10) Adequate organ function
(11) Written informed consent
Key exclusion criteria
(1) History of angle-closure glaucoma
(2) Uncontrollable diabetes mellitus in spite of insulin therapy
(3) Uncontrollable hypertension
(4) Pleural effusion or ascites except for those with little amount
(5) Coronary artery disease under treatment; cardiomyopathy, heart failure, or arrhythmia treated with anti-arrhythmic
(6) HBs antigen positive
(7) HCV antibody positive
(8) HIV antibody positive
(9) Interstitial pneumonia, pulmonary fibrosis
(10) Severe infection
(11) Liver cirrhosis
(12) Other active malignancies; history of lymphoma, myelodysplastic syndrome, or leukemia
(13) Pregnant, possible pregnant, or breastfeeding woman
(14) Severe psychosis
(15) Under systemic corticosteroid therapy
(16) Considered as ineligible by attending physicians for other reasons
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Motoko |
| Middle name | |
| Last name | Yamaguchi |
Organization
Mie University Graduate School of Medicine
Division name
Department of Hematology and Oncology
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
059-231-5418
waniwani@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Kana |
| Middle name | |
| Last name | Miyazaki |
Organization
PEARL5 Coordinating Office
Division name
Department of Hematology and Oncology, Mie University Graduate School of Medicine
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
059-232-1111
Homepage URL
k-myzk@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
CD5+ DLBCL Treatment Study Group
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development, AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Department of Hematology and Oncology, Mie University Graduate School of Medicine
IRB Contact (For public release)
Organization
institutional review board, Mie University School of Medicine
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
Tel
059-232-1111
s-kikaku2@mo.medic.mie-u.ac.jp
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
東北大学病院（宮城県）
筑波大学病院（茨城県）
群馬県立がんセンター（群馬県）
公立藤岡総合病院（群馬県）
埼玉医科大学国際医療センター（埼玉県）
虎の門病院（東京都）
国立病院機構東京医療センター（東京都）
虎の門病院分院（神奈川県）
横浜市立大学（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）
金沢医科大学（石川県）
金沢大学医学部（石川県）
恵寿金沢病院（石川県）
福井県済生会病院（福井県）
藤田医科大学（愛知県）
愛知厚生連海南病院（愛知県）
三重大学医学部（三重県）
京都大学医学部（京都府）
神鋼記念病院（兵庫県）
島根大学医学部附属病院（島根県）
国立病院機構岡山医療センター（岡山県）
国立病院機構四国がんセンター（愛媛県）
国立病院機構九州がんセンター（福岡県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
47
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
Main results already published
Date of protocol fixation
| 2012 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2012 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 23 | Day |
Last modified on
| 2021 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009998
