UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001341 |
|---|---|
| Receipt number | R000001627 |
| Scientific Title | Prospective clinical study of R-CMD therapy for indolent B-cell lymphoma and mantle cell lymphoma |
| Date of disclosure of the study information | 2008/09/01 |
| Last modified on | 2013/08/29 16:45:05 |
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Basic information
Public title
Prospective clinical study of R-CMD therapy for indolent B-cell lymphoma and mantle cell lymphoma
Acronym
R-CMD therapy for indolent B-cell lymphoma
Scientific Title
Prospective clinical study of R-CMD therapy for indolent B-cell lymphoma and mantle cell lymphoma
Scientific Title:Acronym
R-CMD therapy for indolent B-cell lymphoma
Region
| Japan |
Condition
Condition
indolent B-cell lymphoma, mantle cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and the safety of R-CMD (Rituximab, Cladribine, Mitoxantrone, Dexamethasone) for indolent B-cell lymphoma and mantle cell lymphoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
CR rate
Key secondary outcomes
Adverse events, Overall survival, Overall response rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
4 courses of R-CMD therapy (rituximab 375mg/m2, div on day1, Cladribine(2-CDA)0.10 mg/kg,2h div on day1-3, Mitoxantrone(MIT)8mg/m2,div on day1 and Dexamethasone8mg/body on day1-3) , 4 courses of rituximab 375mg/m2, div
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, indolent B-cell lymphoma(follicular lymphoma, marginal zone B-cell lymphoma, MALT, nodular and splenic type, lymphoplasmacytic lymphoma, etc) or mantle cell lymphoma
2, Adult, primary and Ann Arbor stage II-IV
3, informed consent
Key exclusion criteria
1, low or negative expression CD20
2, severe infectious disease
3, Pre-treatment history for lymphoma
4, HIV+, HTLV1+, HBs-Ag+, HBc-Ab high titer
5, Pt who will be treat by allogenic or autologous stem cell transplantation
6, physician's decision of inappropriateness
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasufumi Masaki |
Organization
Kanazawa Medical University
Division name
Hematology and Immunology
Zip code
Address
1-1 Daigaku, Uchinada-machi, Kahoku-gun, Ishikawa
TEL
076-286-3511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasufumi Masaki |
Organization
Kanazawa Medical University
Division name
Hematology and Immunology
Zip code
Address
1-1 Daigaku, Uchinada-machi, Kahoku-gun, Ishikawa
TEL
076-286-3511
Homepage URL
yasum@kanazawa-med.ac.jp
Sponsor or person
Institute
Hematology and Immunology, Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Hematology and Immunology, Kanazawa Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hokuliku Hematological tumor research group
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
| 2008 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.kanazawa-med.ac.jp/~hematol/topics9.html
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
| 2007 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 01 | 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 | 08 | Month | 29 | Day |
Last modified on
| 2013 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001627
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
