UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013117 |
|---|---|
| Receipt number | 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 12:39:56 |
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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
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
kmmihara@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013110
