UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008017 |
|---|---|
| Receipt number | R000009431 |
| Scientific Title | Clinical study to investigate the efficacy of rituximab monotherapy after the rituximab combination chemotherapy for previously untreated follicular lymphoma<THF019> |
| Date of disclosure of the study information | 2012/05/23 |
| Last modified on | 2020/11/30 12:33:30 |
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Basic information
Public title
Clinical study to investigate the efficacy of rituximab monotherapy after the rituximab combination chemotherapy for previously untreated follicular lymphoma<THF019>
Acronym
Clinical study to investigate the efficacy of rituximab monotherapy after the rituximab combination chemotherapy for previously untreated follicular lymphoma<THF019>
Scientific Title
Clinical study to investigate the efficacy of rituximab monotherapy after the rituximab combination chemotherapy for previously untreated follicular lymphoma<THF019>
Scientific Title:Acronym
Clinical study to investigate the efficacy of rituximab monotherapy after the rituximab combination chemotherapy for previously untreated follicular lymphoma<THF019>
Region
| Japan |
Condition
Condition
follicular lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the efficacy of rituximab monotherapy after the rituximab combination chemotherapy for previously untreated follicular lymphoma[FL]
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival at 2 years[2y PFS]
Key secondary outcomes
Best Response Rate, Complete Response Rate, Overall Response Rate, Overall survival, Progression Free Survival, Bcl-2 negative conversion rate, Minimal Residual Disease, Safety
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
Rituximab combination chemotherapy 1course/3W [Maximum 6-8 course]
Rituximab monotherapy 1course/8W[until 2 years]
Rituximab 375 mg/m2 div day0 or day1
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Follicular lymphoma[FL]
[exclude patients with Histologic transformation]
2)grade 1, 2, 3a
3)no previous chemotherapy
4)CD20 positive
5)Age:18 to 74
6)Performance Status:0 to 2
7)having musurable lesion
8-1)WBC:3,000/mm3 or more
Neutrophil:1,200/mm3 or more
Platlets:7.5x10^4/mm3 or more
8-2)AST[GOT]/ALT[GPT]:5xnormal upper
limit or less
T-bil:2.0mg/dL or less
8-3)Creatinine:1.5mg/dL or less
9)Written informed consen
Key exclusion criteria
1)active double cancer
2)severe infection or severe complication
3)having prior drug allergy
4)prior treated heart failure or renal failure
5)Cirrhosis of the liver
6)HBs-Ag positive
7)Disorder of electrocardiogram, Disorder of heart fanction, severe heart disease
8)pregnant/lactating woman
9)psychosis
10)given systemic steroid
11)Physician's decision of inappropriateness
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Eijiro |
| Middle name | |
| Last name | Omoto |
Organization
Yamagata Prefectural Central Hospital
Division name
Department of Hematology
Zip code
990-2292
Address
1800 Aoyagi, Yamagata city, Yamagata, 990-2292, JAPAN
TEL
023-685-2626
ej-omoto@vega.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Eijiro |
| Middle name | |
| Last name | Omoto |
Organization
Yamagata Prefectural Central Hospital
Division name
Department of Hematology
Zip code
990-2292
Address
1800 Aoyagi, Yamagata city, Yamagata, 990-2292, JAPAN
TEL
023-685-2626
Homepage URL
ej-omoto@vega.ocn.ne.jp
Sponsor or person
Institute
TOHOKU HEMATOLOGY FORUM
Institute
Department
Personal name
Funding Source
Organization
Tohoku Hematology Expert Meeting (THEMe)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
TOHOKU HEMATOLOGY FORUM
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Yamagata Prefectural Central Hospital
Address
1800 Aoyagi, Yamagata City, Yamagata
Tel
0236852626
eomoto@ypch.gr.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
| 2012 | Year | 05 | Month | 23 | 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
24
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
| 2012 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 05 | 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
| 2012 | Year | 05 | Month | 23 | Day |
Last modified on
| 2020 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009431
