UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004805 |
|---|---|
| Receipt number | 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 15:40:57 |
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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
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
Sponsor or person
Institute
Biomedics Japan Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005721
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