UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005442 |
|---|---|
| Receipt number | R000006445 |
| Scientific Title | Clinical study to investigate the efficacy and the safety of R-FM for recurrent or refractory indolent B-cell lymphoma - THF016 |
| Date of disclosure of the study information | 2011/06/01 |
| Last modified on | 2013/04/21 12:10:09 |
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Basic information
Public title
Clinical study to investigate the efficacy and the safety of R-FM for recurrent or refractory indolent B-cell lymphoma - THF016
Acronym
R-FM for recurrent or refractory indolent B-cell lymphoma
Scientific Title
Clinical study to investigate the efficacy and the safety of R-FM for recurrent or refractory indolent B-cell lymphoma - THF016
Scientific Title:Acronym
R-FM for recurrent or refractory indolent B-cell lymphoma
Region
| Japan |
Condition
Condition
recurrent or refractory indolent B-cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the efficacy and the safety of R-FM for recurrent or refractory indolent B-cell lymphoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Best Response rate, Complete Response rate, Survival time (Overall survival, Median survival time, 2-year-survival rate etc.), Time to progression, Bcl-2 negative conversion rate, Safety
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 | Gene |
Interventions/Control_1
R-FM 1course/4W (Maximum 6 course)
-Rituximab 375 mg/m2 div day0 or day1
-Mitoxantrone 10 mg/m2 div day1
-Fludarabine 40 mg/m2 po day1, day2, day3
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Indolent B-cell lymphoma (FL, MALT, MZL)
(exclude patients with histologic transformation)
2) having prior chemotherapy
3) CD20 positive
4) Age: 18 to 74
5) Performance Status: 0 to 2
6) having measurable lesion
7-1) WBC: 3,000/mm3 or more
Neutrophil: 1,200/mm3 or more
Platelets: 75,000/mm3 or more
7-2) AST (GOT)/ALT (GPT): 5xnormal upper limit or less
T-bil: 2.0mg/dL or less
7-3) Creatinine: 1.5mg/dL or less
8) Written informed consent
Key exclusion criteria
1) active double cancer
2) severe infection or severe complication
3) having more than 300mg/m2 of Doxorubicin
4) having prior Zevarin
5) having prior purine analog
6) having prior drug allergy
7) prior treated heart failure or renal failure
8) Cirrhosis of the liver
9) HBs-Ag positive
10) Disorder of electrocardiogram, Disorder of heart fanction, severe heart disease
11) pregnant/lactating woman
12) psychosis
13) given systemic steroid
14) Physician's decision of inappropriateness
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takenori Takahata |
Organization
Hirosaki University Graduate School of Medicine
Division name
Division of Medical Oncology
Zip code
Address
5-Zaihucho, Hirosaki, Aomori, 036-8562, JAPAN
TEL
+81-172-39-5346
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takenori Takahata |
Organization
Hirosaki University Graduate School of Medicine
Division name
Division of Medical Oncology
Zip code
Address
5-Zaihucho, Hirosaki, Aomori, 036-8562, JAPAN
TEL
+81-172-39-5346
Homepage URL
takatake@cc.hirosaki-u.ac.jp
Sponsor or person
Institute
Tohoku Hematology Forum
Institute
Department
Personal name
Funding Source
Organization
Tohoku Hematology Forum
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tohoku Hematology Forum
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
弘前大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 08 | 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
| 2011 | Year | 04 | Month | 14 | Day |
Last modified on
| 2013 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006445
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| Registered date | File name |
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