UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001191 |
|---|---|
| Receipt number | R000001401 |
| Scientific Title | A phase II study of the remission induction and maintenance therapy by rituximab for rituximab naive low grade B cell lymphoma. |
| Date of disclosure of the study information | 2008/06/20 |
| Last modified on | 2016/06/16 11:39:07 |
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Basic information
Public title
A phase II study of the remission induction and maintenance therapy by rituximab for rituximab naive low grade B cell lymphoma.
Acronym
Inducion and maintenance therapy by rituximab for low grade B cell lymphoma.
Scientific Title
A phase II study of the remission induction and maintenance therapy by rituximab for rituximab naive low grade B cell lymphoma.
Scientific Title:Acronym
Inducion and maintenance therapy by rituximab for low grade B cell lymphoma.
Region
| Japan |
Condition
Condition
low grade B cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The object of this clinical phase II study is to examine the efficacy and safety of the remission induciton therapy with 8 doses of rituximab and maintenance therapy with 4 doses of rituximab every 6 months for 2 years for the rituximab naive low grade B cell lymphoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
complete response rate, 3 years over all survival, safety, 3 years progression free survival
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
The remission induction therapy with weekly 8 doses of rituximab(375mg/m2) followed by the 4 courses of every 6 months maintenance therapy with weekly 4 doses of rituximab(375mg/m2).
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.pathological diagnosis: low grade B cell lymphoma
2.CD20 antigen positive
3.Ann-Arbor stage: II-IV(without bulky lesion)
4.lymphoma cells less than 5000/mm3 in peripheral blood
5.presence of mesurable lesions
6.rituximab naive
7.hospitaized during first infusion of rituximab
8.PS(ECOG): 0-2
9.adequate organ funcitions
10.informed consented patients
Key exclusion criteria
1.presence of central nervous invasion(clinical or pathological).
2.transformed patients (clinical or pathological).
3.past history of glaucoma.
4.past history of severe drug allergy.
5.HIV Ab positive or HTLV-1 Ab positive.
6.HBsAg positive, HBsAb positive, or HCV Ab positive.
7.severe cardiac disease
8.hepatic cirrhosis
9.uncontrollable diabetis melitus
10.patients with dialysis
11.lung fibrosis or interstitial pneumonitis
12.other active malignancies
13.pregnant or feeding female
14.severe mental disorder
15.systemic therapy with corticosteroid
16.judged for inappropriate with other reasons.
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | HIROKAZU NAGAI |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Clinical Research Center
Zip code
Address
4-1-1, Sannomaru, Naka-ku, Nagoya
TEL
052-951-1111
nagaih@nnh.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | HIROKAZU NAGAI |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Clinical Research Center
Zip code
Address
4-1-1, Sannomaru, Naka-ku, Nagoya
TEL
052-951-1111
Homepage URL
nagaih@nnh.hosp.go.jp
Sponsor or person
Institute
Clinical Hematology Study Group of National Hospital Organization(CHSG-NHO)
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
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
| 2008 | Year | 06 | Month | 20 | 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
| 2005 | Year | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | 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
| 2008 | Year | 06 | Month | 16 | Day |
Last modified on
| 2016 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001401
