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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013117
Receipt No. R000013110
Scientific Title Is monthly administration of rituximab useful in ocular adnexal mucosa-associated lymphoid tissue lymphoma?
Date of disclosure of the study information 2014/02/10
Last modified on 2020/03/19

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Basic information
Public title Is monthly administration of rituximab useful in ocular adnexal mucosa-associated lymphoid tissue lymphoma?
Acronym Is monthly administration of rituximab useful in ocular adnexal mucosa-associated lymphoid tissue lymphoma?
Scientific Title Is monthly administration of rituximab useful in ocular adnexal mucosa-associated lymphoid tissue lymphoma?
Scientific Title:Acronym Is monthly administration of rituximab useful in ocular adnexal mucosa-associated lymphoid tissue lymphoma?
Region
Japan

Condition
Condition Ocular adnexal mucosa-associated lymphoid tissue-type lymphoma (OAL)
Classification by specialty
Hematology and clinical oncology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We administrate monthly rituximab for OAL patient.We asess PFS and safety.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes PFS
Key secondary outcomes

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 Monthly administration of rituximab is performed for ocular adnexal mucosa-associated lymphoid tissue lymphoma(MALT).
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histopathologically, the patient with ocular adnexal extranodal marginal zone B-cell lymphoma (MZL) of mucosa-associatd lymphoid tissue (MALT) type lymphoma
2) The patient who has measurable lesion(major-axis:>1.5cm by computed tomography [CT])
3) A patient age is 80 and below or 20 and over
4) PS is a patient of 0-2.
5) The patient who has the good function of main internal organs (marrow, the heart, a lung, liver, and kidney)
- The number of neutrophils : more than 1,000/mm3
- The number of blood platelets : more than 75,000/mm3
- AST (GOT) : less than 2.5 times of an institution standard value maximum
- ALT (GPT) : less than 2.5 times of an institution standard value maximum
- Total bilirubin : less than 1.5 times of an institution standard value maximum
- Serum creatinine : less than 1.5 times of an institution standard value maximum
- Oxyecoia-partial-pressure (pulse oximeter measurement is possible) PaO2 >=65mmHg
- The unusual view of an electrocardiogram which requires medical treatment is not seen.
6) The patient who wishes the participation in an examination independently and by whom the participating consent document was got in written form
Key exclusion criteria 1) The patient who has clear infection (virus infection is included)
2) The patient who has critical complications (hepatic insufficiency or renal insufficiency)
3) The patient who has a merger or anamnesis of critical cardiac disease (example: myocardial infarction, ischemic heart disease)
4) The patient who has critical digestive symptoms (advanced or serious nausea and vomiting, or diarrhea etc.)
5) The patient who shows a hepatitis B surface antigen, a HCV antibody, or HIV antibody-positive
6) The patient who has critical bleeding tendencies (diffuse-intravascular-coagulation syndrome etc.)
7) The patient who has clinical symptoms which make permeation in a central nervous system, or it suspect
8) The patient who has generation of heat of 38 or more degree C(however, in the case of tumor fever, it removes)
9) The patient who has interstitial pneumonia, pulmonary fibrosis, and pulmonary emphysema, or the patient accepted in the past
10) The patient who has active double cancer
11) The patient who has autoimmune hemolytic anemia, or the patient accepted in the past
12) A patient with the past of the critical hypersensitivity to mouse protein origin products, or an anaphylactic reaction
13) A pregnant woman or the patient that may have become pregnant, the patient under breast-feeding
14) The patient who cannot consent to contraception regardless of man and woman
15) In addition, the patient who judged that a doctor was unsuitable
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keichiro Mihara
Organization Hiroshima University hospital
Division name hematology
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima-city
TEL 082-257-5861
Email kmmihara@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuji Mino
Organization Hiroshima University hospital
Division name hematology
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima-city
TEL 0822575861
Homepage URL
Email kmmihara@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University hospital
Institute
Department

Funding Source
Organization All are provided by the donation to this department and research fund offer from the organization of a specific company, an organization, etc. is not received.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 02 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2013 Year 08 Month 01 Day
Date of IRB
2013 Year 10 Month 04 Day
Anticipated trial start date
2014 Year 02 Month 10 Day
Last follow-up date
2020 Year 03 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 10 Day
Last modified on
2020 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013110

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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