UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of the remission induction and maintenance therapy by rituximab for rituximab naive low grade B cell lymphoma.
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	HIROKAZU NAGAI
Organization	National Hospital Organization Nagoya Medical Center
Division name	Clinical Research Center
Address	4-1-1, Sannomaru, Naka-ku, Nagoya
TEL	052-951-1111
Email	nagaih@nnh.hosp.go.jp

Public contact
Name of contact person	HIROKAZU NAGAI
Organization	National Hospital Organization Nagoya Medical Center
Division name	Clinical Research Center
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2005 Year 08 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000001401