UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003823 |
|---|---|
| Receipt number | R000004501 |
| Scientific Title | Randomized phase II study of biweekly R-CHOP versus biweekly R-CHOP followed by CHASER as induction therapy for high-dose chemotherapy, LEED, and autologous stem-cell transplantation in poor-risk diffuse large B-cell lymphoma (JCOG0908, DLBCL-bi-R-CHOP/CHASER-LEED-rP2 ) |
| Date of disclosure of the study information | 2010/06/25 |
| Last modified on | 2015/02/13 17:52:28 |
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Basic information
Public title
Randomized phase II study of biweekly R-CHOP versus biweekly R-CHOP followed by CHASER as induction therapy for high-dose chemotherapy, LEED, and autologous stem-cell transplantation in poor-risk diffuse large B-cell lymphoma (JCOG0908, DLBCL-bi-R-CHOP/CHASER-LEED-rP2 )
Acronym
DLBCL-bi-R-CHOP/CHASER-LEED-rP2 (JCOG0908)
Scientific Title
Randomized phase II study of biweekly R-CHOP versus biweekly R-CHOP followed by CHASER as induction therapy for high-dose chemotherapy, LEED, and autologous stem-cell transplantation in poor-risk diffuse large B-cell lymphoma (JCOG0908, DLBCL-bi-R-CHOP/CHASER-LEED-rP2 )
Scientific Title:Acronym
DLBCL-bi-R-CHOP/CHASER-LEED-rP2 (JCOG0908)
Region
| Japan |
Condition
Condition
diffuse large B-cell lymphoma, including subtypes; lymphomatoid granulomatosis, grade 3; primary mediastinal (thymic) large B-cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Randomized phase II trial to compare biweekly RCHOP plus CHASER to biweekly RCHOP as an induction regimen for high-dose therapy, LEED, with autologous peripheral blood stem cell transplantation for patients with diffuse large B-cell lymphomas in the high-intermediate and high risk International Prognostic Index groups
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
2-year progression free survival rate
Key secondary outcomes
Overall response rate and complete response rate of both the entire treatment courses and the induction phases, 2-year and 5-year overall survival rate, 5-year progression free survival rate, adverse events, serious adverse events, and incidence rate of secondary malignancies
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A: biweekly RCHOP 6 courses followed by LEED with autologous peripheral blood stem cell transplantation
Interventions/Control_2
B: Biweekly RCHOP 3 courses and CHASER 3 courses followed by LEED with autologous peripheral blood stem cell transplantation
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically confirmed diffuse large B-cell lymphoma, including subtypes of T cell/histiocyte rich large B-cell lymphoma, primary cutaneous DLBCL leg type and EBV positive DLBCL of the elderly, lymphomatoid granulomatosis grade 3, and primary mediastinal (thymic) large B-cell lymphoma by the WHO classification 4th edition
2) Positive for CD20 in lymphoma cells by immunohistochemical or flowcytometric analysis
3) Aged 20 to 65 years old
4) Performance status (PS) of 0-2 on ECOG(Eastern Cooperative Oncology Group) scale
5) Stage III or IV disease, or stage II with bulky disease
6) High-intermediate or high risk group on AA-IPI (Age-adjusted International Prognostic Index) score
7) Lymphoma cells in peripheral blood <=10,000/mm3 within 14 days prior to registration
8) No testicular or central nervous system involvement
9) Having an measurable lesion
10) No previous history of chemotherapy, radiation therapy, interferon and/or antibody
11) Adequate hematological and major organ function
12) Written informed consent
Key exclusion criteria
1) History of glaucoma
2) Diabetes mellitus regularly treated with insulin or uncontrollable diabetes mellitus
3) Uncontrollable hypertension
4) Serious cardiac conditions such as coronary disease, myocardiopathy and/or heart failure that requires treatment, and/or arrhythmia treated with antiarrhythmic
5) Positive test for HBs antigen
6) Positive test for HCV antibody
7) Positive test for HIV antibody
8) Interstitial pneumonia, pulmonary fibrosis or severe pulmonary emphysema
9) Other active malignancies
10) Severe infection that requires systemic therapy
11) Fever above 38 degrees Celsius except related to B symptoms
12) Pregnant, possible pregnant, or breastfeeding woman
13) Psychological disease or condition that precludes participation in clinical trial
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhito Yamamoto |
Organization
Aichi Cancer Center
Division name
Department of Hematology and Cell Therapy
Zip code
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan
TEL
052-762-6111
kyamamoto@aichi-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhito Yamamoto |
Organization
JCOG0908 Coordinating Office
Division name
Department of Hematology and Cell Therapy, Aichi Cancer Center
Zip code
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan
TEL
052-762-6111
Homepage URL
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group (JCOG)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
国立病院機構北海道がんセンター（北海道）
札幌北楡病院（北海道）
東北大学病院（宮城県）
秋田大学医学部（秋田県）
太田西ノ内病院（福島県）
群馬大学医学部附属病院（群馬県）
埼玉県立がんセンター（埼玉県）
埼玉医科大学総合医療センター（埼玉県）
国立がん研究センター東病院（千葉県）
千葉県がんセンター（千葉県）
国立がん研究センター中央病院（東京都）
杏林大学医学部（東京都）
がん・感染症センター都立駒込病院（東京都）
東京慈恵会医科大学附属病院（東京都）
東京慈恵会医科大学第三病院（東京都）
がん研究会有明病院（東京都）
NTT東日本関東病院（東京都）
東海大学医学部（神奈川県）
金沢医科大学（石川県）
福井大学医学部附属病院（福井県）
浜松医科大学（静岡県）
愛知県がんセンター中央病院（愛知県）
国立病院機構名古屋医療センター（愛知県）
名古屋大学医学部（愛知県）
名古屋市立大学病院（愛知県）
名古屋第二赤十字病院（愛知県）
愛知医科大学附属病院（愛知県）
豊田厚生病院（愛知県）
三重大学医学部（三重県）
滋賀県立成人病センター（滋賀県）
京都府立医科大学（京都府）
兵庫県立がんセンター（兵庫県）
広島大学病院（広島県）
国立病院機構四国がんセンター（愛媛県）
愛媛大学医学部附属病院（愛媛県）
国立病院機構九州がんセンター（福岡県）
福岡大学医学部（福岡県）
国立病院機構九州医療センター（福岡県）
産業医科大学（福岡県）
佐賀大学医学部（佐賀県）
国立病院機構長崎医療センター（長崎県）
佐世保市立総合病院（長崎県）
長崎大学病院（長崎県）
熊本大学医学部（熊本県）
国立病院機構熊本医療センター（熊本県）
大分県立病院（大分県）
鹿児島大学医学部・歯学部附属病院（鹿児島県）
今村病院分院（鹿児島県）
琉球大学医学部附属病院（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 06 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 25 | Day |
Last modified on
| 2015 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004501
