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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031459
Receipt No. R000035786
Scientific Title Phase II study of safety and efficacy of alternating R-CHOP and R-HDMA therapy in high-risk diffuse large B-cell lymphoma
Date of disclosure of the study information 2018/03/01
Last modified on 2019/08/27

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Basic information
Public title Phase II study of safety and efficacy of
alternating R-CHOP and R-HDMA therapy in
high-risk diffuse large B-cell lymphoma
Acronym Safety and efficacy of alternating R-CHOP and R-HDMA therapy in high-risk DLBCL
Scientific Title Phase II study of safety and efficacy of
alternating R-CHOP and R-HDMA therapy in
high-risk diffuse large B-cell lymphoma
Scientific Title:Acronym Safety and efficacy of alternating R-CHOP and R-HDMA therapy in high-risk DLBCL
Region
Japan

Condition
Condition diffuse large B-cell lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate efficacy of alternating R-CHOP and R-HDMA therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 2-year progression-free survival rate
Key secondary outcomes 2-year overall survival rate
Response rate
Adverse event
Completion rate of protocol treatment
Duration of therapy

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 8 courses of alternating R-CHOP and R-HDMA therapy
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
16 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria 1 Histologically confirmed DLBCL
2 No previous chemotherapy
3 Evaluable disease
4 Confirmed to be CD20-positive lymphoma by flowcytometry or immunohistochemistry
5 Age: between 16 and 70
6 PS scale: between 0 and 2
7 Revised IPI; poor
8 No organ dysfunction; leukocyte count more than 2000/mm3, neutrophil count more thhan 1000/mm3, platelet count more than 10000/mm3, AST and ALT less than 150IU/L, total bilirubin less than 2.0 mg/dl, serum creatinine less than 2.0 mg/dl, SpO2 more than 93% (room air), normal ECG.
9 Obtaining written informed consent.
Key exclusion criteria 1 Involvement of central nervous system
2 HBs antigen positive
3 HCV antibody positive
4 HIV antibody positive
5 Active synchronous malignancy
6 Patients who are pregnant, lactating, or possibly pregnant
7 Patients who receive steroid therapy for other diseases
8 Patients with uncontrolled infection
9 Severe allergy to drugs used in this study
10Patients who the researcher judged inappropriate as the subject
Target sample size 26

Research contact person
Name of lead principal investigator
1st name Takehiko
Middle name
Last name Mori
Organization Keio University School of Medicine
Division name Hematology Division
Zip code 160-0016
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1211
Email tmori@a3.keio.jp

Public contact
Name of contact person
1st name Ryohei
Middle name
Last name Abe
Organization Keio University School of Medicine
Division name Hematology Division
Zip code 160-0016
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1211
Homepage URL
Email r.abe0819@keio.jp

Sponsor
Institute Division of Hematology, Keio University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Keio University School of Medicine Ethics Review Committee
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel 03-3353-1211
Email med-rinri-jimu@adst.keio.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

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 01 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
2017 Year 09 Month 11 Day
Date of IRB
2018 Year 02 Month 26 Day
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
2021 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 24 Day
Last modified on
2019 Year 08 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035786

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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