UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002974 |
|---|---|
| Receipt number | 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 11:01:57 |
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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
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
Sponsor or person
Institute
Zenyaku Kogyo Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003607
