UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053834 |
|---|---|
| Receipt number | R000061438 |
| Scientific Title | Incidence and Prophylactic Administration of Febrile Neutropenia among Untreated Diffuse Large B-Cell Lymphoma Patients Including Those Over 80 Years of Age: A Descriptive Study Using A Japanese Administrative Database. |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2025/08/21 15:07:47 |
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Basic information
Public title
Incidence and Prophylactic Administration of Febrile Neutropenia among Untreated Diffuse Large B-Cell Lymphoma Patients Including Those Over 80 Years of Age: a descriptive study using a Japanese administrative database.
Acronym
Incidence and Prophylactic Administration of Febrile Neutropenia among Untreated Diffuse Large B-Cell Lymphoma Patients Including Those Over 80 Years of Age: a descriptive study using a Japanese administrative database.
Scientific Title
Incidence and Prophylactic Administration of Febrile Neutropenia among Untreated Diffuse Large B-Cell Lymphoma Patients Including Those Over 80 Years of Age: A Descriptive Study Using A Japanese Administrative Database.
Scientific Title:Acronym
Incidence and Prophylactic Administration of Febrile Neutropenia among Untreated Diffuse Large B-Cell Lymphoma Patients Including Those Over 80 Years of Age: A Descriptive Study Using A Japanese Administrative Database.
Region
| Japan |
Condition
Condition
Diffuse Large B-Cell Lymphoma
Classification by specialty
| Hematology and clinical oncology | Infectious disease |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to understand the real-world treatment landscape of Pola-R-CHP therapy, one of the standard treatments for untreated diffuse large B-cell lymphoma (DLBCL), and to contribute to further safety measures. Specifically, this study will describe the incidence of febrile neutropenia (FN), anemia, and thrombocytopenia, as well as the reality of primary prophylactic administration of G-CSF preparations, by dividing the subjects into groups: those aged 80 and above and some other age categories. Additionally, the study will similarly describe the real-world situations of peripheral neuropathy (PN), constipation, and diarrhea.
To verify the validity of the results, this study will also examine the incidence of adverse events and the proportion of interventions in untreated DLBCL patients who have received R-CHOP therapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
During the 1st Pola-R-CHP therapy where untreated DLBCL patients are treated (for 6 cycles at most) followed by a 90-day safety assessment period, the following will be assessed for the overall population as well as by age group:
- the incidence of adverse events related to bone marrow suppression (FN), G-CSF prophylactic administration, and the proportion or cumulative incidence of interventions (such as transfusions for anemia and thrombocytopenia),
- calculation of the trend in the proportion of dose reductions of the medication (cyclophosphamide, polatuzumab vedotin, doxorubicin hydrochloride),
- and estimation of the distributions of the number of days and frequency of hospitalization.
Key secondary outcomes
First, in the R-CHOP group, the same items as in the Pola-R-CHP group will be evaluated.
Next, for untreated DLBCL patients receiving 1st line Pola-R-CHP or R-CHOP treatment (up to 6 cycles) + a maximum follow-up period of 90 days, the following will be conducted for both the overall population and by age group:
- estimation of the incidence of constipation, diarrhea, and PN requiring treatment,
- and calculation of the frequency of the number and types of medications used in the treatment of constipation and PN.
Furthermore, in each group or in the combined population, the following will be evaluated:
- the temporal trend in the incidence of FN,
- the proportion of days of prophylactic administration of G-CSF,
- the distribution of days of primary prophylactic administration of G-CSF in the first cycle,
- and the incidence of FN by age group and prophylaxis with G-CSF.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients must have a record of DLBCL (Diffuse Large B-Cell Lymphoma) during the patient enrollment period (from September 2022 to September 2023).
DLBCL: ICD-10 code C83.3 excluding "8847396 Primary Central Nervous System Diffuse Large B-Cell Lymphoma", or "8847326 Intravascular Large B-Cell Lymphoma" and "8847364 Mediastinal (Thymic) Large B-Cell Lymphoma". All records with a suspicious flag are not used.
Key exclusion criteria
The earliest day of prescription for R-CHOP or Pola-R-CHP is not included in the patient enrollment period.
No tests such as CD20 are performed prior to 60 days of the index date.
Index date: the first prescription day of the 1st line 1st cycle.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Kozuka |
Organization
Chugai Pharmaceutical Co., Ltd.
Division name
Safety Science Dept. 2
Zip code
103-8324
Address
1-1 Nihonbashi-Muromachi 2-chome, Chuo-ku, Tokyo
TEL
03-3281-6611
kozukadis@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Kozuka |
Organization
Chugai Pharmaceutical Co., Ltd.
Division name
Safety Science Dept. 2
Zip code
103-8324
Address
1-1 Nihonbashi-Muromachi 2-chome, Chuo-ku, Tokyo
TEL
03-3281-6611
Homepage URL
kozukadis@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co., Ltd.
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
N/A
Address
N/A
Tel
03-3281-6611
kozukadis@chugai-pharm.co.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
| 2024 | Year | 04 | 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
Completed
Date of protocol fixation
| 2024 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Organization providing data]
Medical Data Vision Co., Ltd.
Management information
Registered date
| 2024 | Year | 03 | Month | 12 | Day |
Last modified on
| 2025 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061438
