UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031459 |
|---|---|
| Receipt number | 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 | 2021/04/02 12:57:40 |
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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
tmori@a3.keio.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Mizuno |
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
kota10@keio.jp
Sponsor or person
Institute
Division of Hematology, Keio University School of Medicine
Institute
Department
Personal name
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
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
5
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
Terminated
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
| 2021 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035786
