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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002974
Receipt No. R000003607
Scientific Title Post-marketing clinical study of rituximab monotherapy at eight weekly infusions in relapsed or refractory patients with indolent B-cell non-Hodgkin's lymphoma
Date of disclosure of the study information 2010/01/05
Last modified on 2010/01/05

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Basic information
Public title Post-marketing clinical study of rituximab monotherapy at eight weekly infusions in relapsed or refractory patients with indolent B-cell non-Hodgkin's lymphoma
Acronym Post-marketing clinical study of rituximab monotherapy at eight weekly infusions in relapsed or refractory patients with indolent B-cell non-Hodgkin's lymphoma
Scientific Title Post-marketing clinical study of rituximab monotherapy at eight weekly infusions in relapsed or refractory patients with indolent B-cell non-Hodgkin's lymphoma
Scientific Title:Acronym Post-marketing clinical study of rituximab monotherapy at eight weekly infusions in relapsed or refractory patients with indolent B-cell non-Hodgkin's lymphoma
Region
Japan

Condition
Condition Indolent non Hodgkin's lymphomas
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of rituximab monotherapy at 375 mg/m2 with weekly eight infusions in relapsed or refractory indolent B-cell lymphomas.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Overall response rate (ORR) for eligible patients
Key secondary outcomes 1."Progression free survival" for eligible patients and "Time to progression" for responder patients
2.frequency and severity of adverse events for all treated patients
3.pharmacokinetic parameters

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 The dosage and schedule of rituximab in this study is 375 mg/m2 x eight weekly infusions.
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.CD20 positive B-cell lymphoma confirmed by histopathological diagnosis. The expression of CD20 antigen on lymphoma cells to be confirmed by either immunohistochemistry or flow cytometry.
2.NHLs diagnosed as follows according to WHO classification by biopsy.
1)Small lymphocytic lymphoma
2)Lymphoplasmacytic lymphoma
3)Splenic marginal zone B-cell lymphoma
4)Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue type
5)Nodal marginal zone B-cell lymphoma
6)Follicular lymphoma
3.Target lesion(s) for evaluation
Patients with measurable lesion(s) meeting the following criteria defined by the Lymphoma Study Group of Japan Clinical Oncology Group according to the International Workshop Criteria.
1)Enlarged lympho node and/or mass, or extra nodal mass diagnosed as malignant lymphoma.
2)Presence of bi-dimensionally measurable disease lesion(s) confirmed on CT film.
3)The greatest diameter of the lesion longer than 1.5cm.
4.Patients who failed to respond to the prior chemotherapy or who relapsed after achieving clinically complete or partial response to the prior chemotherapy.
5.The last chemotherapy should have been completed at least four weeks prior to the entry
6.HBs antigen and HCV antibody must be negative serologically within four weeks prior to the entry.
7.Life expectancy > 2 months after the initial infusion.
8.Performance status < 2 on the Eastern Cooperative Oncology Group scale.
9.Ann Arbor clinical stage I-IV at the entry.
10.Age must be between 20 and 79 years old
11.Patients should have adequate organ function as follows:
1)Bone marrow function absolute neutrophil count>=1,200/uL
platelet count>=75,000/uL
2)Hepatic function
AST<4.0xNu
ALT<4xNu
TB<2.0xNu
3)Renal function
serum creatinine<1.5xNu
4)Cardiopulmonary function
PaO2>=65 mmHg
12.All patients are required to stay in hospital for at least two days after the first infusion of rituximab.
13.All patients who signed an informed consent form by him/herself for participating in this study.
Key exclusion criteria 1. Prior treatment history
1)Patients who received rituximab within the past one year.
2)Previous treatment with a murine, chimeric or humanized MoAb other than rituximab
3)Patients with positive human anti-chimeric antibody (HACA)
4)Treatment with investigational new drugs under development at least six months prior to the entry into the study.
5)Previous treatment with hematopoietic growth factors such as granulocyte-colony stimulating factor (G-CSF) within one week prior to the entry.
2. Patients whose lymphoma cells in peripheral blood (PB) exceed 5,000/uL.
3. Concomitant and /or previous diseases
1)Seropositive for human immunodeficiency virus (HIV) antibody.
2)Patients with active hepatitis, ongoing infection and serious illness.
3)Patients with active concomitant malignancies.
4)Presence or history of CNS involvement, or patients with suspicion of CNS involvement.
5)Patients with serious mental disorder.
4. Pregnant or lactating women, women with positive of pregnancy test, or women of child bearing potential.
5. Patients who entered the other clinical studies.
Target sample size 52

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kensei Tobinai, MD, PhD
Organization National Cancer Center Hospital
Division name Hematology Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL +81-3-3542-2511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Izumi Okugaito
Organization Zenyaku Kogyo Co., Ltd.
Division name Clinical development promotion section
Zip code
Address 6-15, Otsuka 5-chome, Bunkyo-ku, Tokyo 112-8650 Japan
TEL +81-3-3946-1113
Homepage URL
Email

Sponsor
Institute Zenyaku Kogyo Co., Ltd.
Institute
Department

Funding Source
Organization Zenyaku Kogyo Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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
2010 Year 01 Month 05 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 Completed
Date of protocol fixation
2004 Year 05 Month 28 Day
Date of IRB
Anticipated trial start date
2004 Year 11 Month 01 Day
Last follow-up date
2008 Year 07 Month 01 Day
Date of closure to data entry
2009 Year 12 Month 01 Day
Date trial data considered complete
2009 Year 12 Month 01 Day
Date analysis concluded
2009 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 01 Month 05 Day
Last modified on
2010 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003607

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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