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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008017
Receipt No. 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 2019/11/29

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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
Email 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
Email ej-omoto@vega.ocn.ne.jp

Sponsor
Institute TOHOKU HEMATOLOGY FORUM
Institute
Department

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
Email 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
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
2019 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009431

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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