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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001191
Receipt No. 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

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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
Email 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
Email nagaih@nnh.hosp.go.jp

Sponsor
Institute Clinical Hematology Study Group of National Hospital Organization(CHSG-NHO)
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001401

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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