UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001603
Receipt No. R000001923
Scientific Title A multicenter phase II open-label study in untreated patients with CD20 positive indolent B-cell non-Hodgkin's lymphoma evaluating efficacy and safety of maintenance therapy with IDEC-C2B8.
Date of disclosure of the study information 2008/12/26
Last modified on 2013/12/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A multicenter phase II open-label study in untreated patients with CD20 positive indolent B-cell non-Hodgkin's lymphoma evaluating efficacy and safety of maintenance therapy with IDEC-C2B8.
Acronym Japanese Phase II study for Rituximab Maintenance
Scientific Title A multicenter phase II open-label study in untreated patients with CD20 positive indolent B-cell non-Hodgkin's lymphoma evaluating efficacy and safety of maintenance therapy with IDEC-C2B8.
Scientific Title:Acronym Japanese Phase II study for Rituximab Maintenance
Region
Japan

Condition
Condition Untreated patients with CD20 positive indolent B-cell non-Hodgkin's lymphoma.
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess efficacy and safety of maintenance therapy with IDEC-C2B8 after induction with 6 cycles of R-CHOP followed by 2 infusions of IDEC-C2B8 in untreated patients with CD20 positive indolent B-cell non-Hodgkin's lymphoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression-free survival (PFS) rate at the years of 4 (4-yr PFS rate).
Key secondary outcomes

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 In the induction phase, patients have to respond to 6 cycles of R-CHOP and 2 infusions of IDEC-C2B8 in order to move to the maintenance phase. After the maintenance period, patients will be followed-up for about 1.5 years additionally.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1)Confirmed CD20 positive indolent NHL
2)Patients previously untreated with chemotherapy immunotherapy, immunochemotherapy, immunoradiotherapy.
3)Patients with at least one of the following signs or symptoms requiring initiation of treatment:
i)Bulky disease at study entry: nodal or extra-nodal mass (except spleen) > 7cm in its greater diameter
ii)B symptoms
iii)Elevated serum LDH or beta2-microglobulin
iv)involvement of at least 3 nodal sites (each with a diameter greater than 3 cm)
v)symptomatic splenic enlargement
vi)Compressive syndrome
vii)Pleural/peritoneal effusion
- Life expectancy > 6 months.
4)Performance status < 2 on the ECOG scale.
5)Patients between 20 years and 80 years.
6)Adequate organ function within 28 days
i) Hematological function
-Absolute neutrophil counts > 1,500/uL
-Platelet conts > 100,000/uL
-Hemoglobin > 8.0g/dL
ii) Hepatic function
-AST < 3.0 x the upper limit of normal
-ALT < 3.0 x the upper limit of normal
-Total bilirubin < 2.0 mg/dL
iii) Renal function
-Serum creatinine < 2.0 mg/dL
iv) Cardiac function
-LVEF > 50%
-PaO2 > 65 mmHg
7)Hospitalization
8)Patients who signed a written informed consent form.
Key exclusion criteria 1)Treatment history
i)With a history of other monoclonal antibody treatment.
ii)Have participated in other clinical trial(s) for unapproved agent or treated with unapproved indication within 6 months prior to registration
iii)Who received G-CSF within 7days prior to trial entry
iv)With a history of sensitive or allergic to murine-derived materials
v)Having received major surgery (excluding lymph node biopsy) within 28 days prior to registration
2)Follicular lymphoma Grade 3b
3)Tumor cells in peripheral blood > 10,000/uL
4)Co-existing medical conditions or previous disease
i)Known HIV infection
ii)Known active HBV or HCV infection and/or known positive in any one of HBs antigen, HBs antibody, HBc antibody or HCV antibody by laboratory tests within 28 days prior to registration
5)Patients with infections and serious underlying medical conditions which could impair the ability of the patient to participate in the trial
6)Patients who routinely use insulin by self injection.
7)Patients with prior or concomitant malignancies
8)Presence or history of CNS lymphoma infiltration
9)Serious psychological conditions
10)Women who are pregnant, breast feeding or positive of pregnant test.
11)Women and men who do not agree to use effective contraception during participation in the trial and for 12 months thereafter.
Target sample size 58

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kensei Tobinai, M.D., Ph.D.
Organization National Cancer Center Hospital
Division name Hematology Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045 JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tsunehiko Ito
Organization Zenyaku Kogyo Co., Ltd.
Division name Clinical Development
Zip code
Address
TEL 03-3946-1113
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

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 12 Month 26 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
2008 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2013 Year 11 Month 29 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 12 Month 26 Day
Last modified on
2013 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001923

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.