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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004805
Receipt No. R000005721
Scientific Title An open-label, phase I study of BM-ca in indolent B cell Non-Hodgkin's lymphoma patients, refractory to or relapsed after Rituximab treatment
Date of disclosure of the study information 2011/02/14
Last modified on 2012/07/31

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Basic information
Public title An open-label, phase I study of BM-ca in indolent B cell Non-Hodgkin's lymphoma patients, refractory to or relapsed after Rituximab treatment
Acronym An open-label, phase I study of BM-ca in indolent B cell Non-Hodgkin's lymphoma patients, refractory to or relapsed after Rituximab treatment
Scientific Title An open-label, phase I study of BM-ca in indolent B cell Non-Hodgkin's lymphoma patients, refractory to or relapsed after Rituximab treatment
Scientific Title:Acronym An open-label, phase I study of BM-ca in indolent B cell Non-Hodgkin's lymphoma patients, refractory to or relapsed after Rituximab treatment
Region
Japan

Condition
Condition Indolent B cell Non-Hodgkin's lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate safety (primary endpoint), efficacy and PK profile (secondary endpoints) of BM-ca therapy to indolent B cell Non-Hodgkin's lymphoma patients, refractory to or relapsed after Rituximab treatment
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary outcome is to evaluate safety of BM-ca therapy from any adverse events and dose limiting toxicities.
Key secondary outcomes Secondary outcome is to evaluate efficacy of BM-ca therapy from Overall Response Rate, Progression-Free Survival and Response Duration.
Another outcome is to test Pharmacokinetics parameters.

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 BM-ca 5mg/Kg 1/week x4week
Interventions/Control_2 BM-ca 10mg/Kg 1/week x4week
Interventions/Control_3 BM-ca 15mg/Kg 1/week x4week
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
74 years-old >=
Gender Male and Female
Key inclusion criteria 1) Aged from 20 to 74
2) Zero or 1 of Performance Status (ECOG)
3) CD20 positive in lymphoma cell
4) Refractory to or relapsed after Rituximab therapy
5) Extended more than 12 weeks from the latest Rituximab infusion and extended more than 4 weeks from the other therapeutic treatments
6) Expected more than three months of survival period
7) At least one measurable lesion with > 15 mm end of volume
8) No history of higher concentration of steroid treatment for more than 4 weeks prior to first infusion
9) Adequate organ function
a.Hemoglobin > 10g/dL
b.Platelet count > 75000/microL
c.Neutrophil count>1500/mm3
d.Creatinine < 1.5X upper limit of normal
e.Bilirubin < 1.5X upper limit of normal
f.ALT <2.5X upper limit of normal
10) Signed in an informed consent for participating to this study
Key exclusion criteria 1) Presence or suspicion of CNS involvement
2) History of congestive heart failure, any other clinical or psychiatric diagnoses which affect to outcomes of this study, as concomitant malignancies in other organs within 5 years
3) Regarding to the safety
a.Positive to HBs antigen, HBc, HCV and HIV antibodies
b.Concomitant cardiovascular or lung, hematologic diseases
c.History of any other malignancies other than lymphoma within 5 years
d.Serious mental disorder
e.Pregnant including suspicious or lactating, or no willing to contraception until further 6 months after final infusion.
f.Entry to other clinical study at least four months prior to the entry into this study
g.Allergy to pharmaceuticals of proteins
h.Suspicious transformation to aggressive lymphomas
i.History of autologous haematopoietic stem cell transplantation
j.diagnosed as ineligible to be entered to this study
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ohtsura Niwa
Organization Biomedics Japan Inc.
Division name Company President
Zip code
Address 5F, Tokyo-Suisan Bldg, 4-18, Toyomi-Cho, Chuo-Ku, Tokyo 104-0055
TEL 03-6240-4685
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Biomedics Japan Inc.
Division name Clinical Development
Zip code
Address 5F, Tokyo-Suisan Bldg, 4-18, Toyomi-Cho, Chuo-Ku, Tokyo 104-0055
TEL 03-6240-4685
Homepage URL
Email

Sponsor
Institute Biomedics Japan Inc.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2011 Year 02 Month 14 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
2010 Year 12 Month 16 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 Day
Last follow-up date
2012 Year 05 Month 31 Day
Date of closure to data entry
2012 Year 07 Month 06 Day
Date trial data considered complete
2012 Year 07 Month 06 Day
Date analysis concluded
2012 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 12 Month 29 Day
Last modified on
2012 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005721

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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