UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000001220
Receipt No. R000001462
Scientific Title Phase II study of rituximab containing induction chemotherapy (R-high-CHOP followed by CHASER) and high-dose chemotherapy (LEED) supported with auto-PBSCT for previously untreated patients with advanced mantle cell lymphoma(JCOG0406)
Date of disclosure of the study information 2008/06/30
Last modified on 2022/08/30 (Ver. 10)

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Basic information
Public title Phase II study of rituximab containing induction chemotherapy (R-high-CHOP followed by CHASER) and high-dose chemotherapy (LEED) supported with auto-PBSCT for previously untreated patients with advanced mantle cell lymphoma(JCOG0406)
Acronym Phase II study of rituximab containing induction chemotherapy (R-high-CHOP followed by CHASER) and high-dose chemotherapy (LEED) supported with auto-PBSCT for previously untreated patients with advanced mantle cell lymphoma(JCOG0406)
Scientific Title Phase II study of rituximab containing induction chemotherapy (R-high-CHOP followed by CHASER) and high-dose chemotherapy (LEED) supported with auto-PBSCT for previously untreated patients with advanced mantle cell lymphoma(JCOG0406)
Scientific Title:Acronym Phase II study of rituximab containing induction chemotherapy (R-high-CHOP followed by CHASER) and high-dose chemotherapy (LEED) supported with auto-PBSCT for previously untreated patients with advanced mantle cell lymphoma(JCOG0406)
Region
Japan

Condition
Condition newly diagnosed advanced mantle cell lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate efficacy and safety of rituximab containing induction chemotherpy (R-high-CHOP/CHASER) followed by high-dose chemotherapy (LEED) with auto-PBSCT for the newly diagnosed patients with advanced (stage II bulky, III or IV) mantle cell lymphoma.
Basic objectives2 Safety,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 progression-free survival (PFS), 5-year PFS rate, overall survival (OS), 2-year OS rate, 5-year OS rate,complete response rate (%CR), overall response rate(ORR), %CR and ORR after induction therapy, incidense of adverse events, incidense of secindary neoplasms

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 Phase II study to investigate efficacy and safety of rituximab containing induction chemotherpy (R-high-CHOP/CHASER) followed by high-dose chemotherapy (LEED) with auto-PBSCT for the newly diagnosed patients with advanced (stage II bulky, III or IV) mantle cell lymphoma.
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
65 years-old >=
Gender Male and Female
Key inclusion criteria 1) pathohistological proved mantle cell lymphoma
2) positive for cyclin D1 in cell nucleus by immunohisitochemical technich
3) positive for CD5 and CD20 in lymphoma cells by flowcytometric analysis or immunohistochemical analysis
4) age : 20-65
5) performance status (PS) of 0-2
6) clinical stage of II bulky, III, or IV
7) peripheral lymphoma cells <=10,000/mm3
8) no CNS involvement
9) evaluable lesion
10) no previous history of chemotherapy, radiation therapy, interferon and/or antibody
11) no major organ dysfunction
12) patient's written informed consent
Key exclusion criteria 1) history of glaucoma
2) in-treatment diabetes mellitus with insulin, or uncontrollable diabetes mellitus
3) uncontrollable hypertension
4) treatemnt required coronary disease, myocardiopathy and/or heart failure, and/or in-treatment arrythmia
5) positibe test for HBs antigen
6) positive test for HCV antibody
7)positive test for HIV antibody
8) interstitial pneumonia, pulmonary fibrosis or severe pulmonaly emphysema
9) severe bacterial infection
10) active another neoplasm
11) pregnant woman, or possible pregnant woman, or lactating woman
12) psychological disease or psychological symptom that seems to bedisturbe to participate in clinical trial
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Morishima
Organization Aichi Cancer Center
Division name Dept. of Hematology & Cell Therapy
Zip code
Address 1-1 Kanokoden, Chikusaku, Nagoya, Aichi, 464-8681 Japan
TEL 052-762-6111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Michinori Ogura
Organization JCOG0406 Coordinating Office
Division name Dept. of Hematology & Oncology, Nagoya Daini Red Cross Hospital
Zip code
Address 2-9 Myokencho, Showaku, Nagoya, Aichi, 466-8650 Japan
TEL 052-832-1121
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

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
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 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）
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）
東京医科大学病院 （東京都）
がん・感染症センター都立駒込病 （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）
癌研究会有明病院（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）
新潟県立がんセンター新潟病院 （新潟県）
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）
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）
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 （（長崎県））
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）

Other administrative information
Date of disclosure of the study information
2008 Year 06 Month 30 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
2008 Year 05 Month 22 Day
Date of IRB
2008 Year 06 Month 27 Day
Anticipated trial start date
2008 Year 06 Month 01 Day
Last follow-up date
2017 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 06 Month 30 Day
Last modified on
2022 Year 08 Month 30 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001462