UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001416 |
|---|---|
| Receipt number | R000001727 |
| Scientific Title | A multi institutional phase II study of oral fludarabine and rituximab (F-R therapy) for patients with relapsed or refractory mantle cell lymphoma. |
| Date of disclosure of the study information | 2008/10/11 |
| Last modified on | 2013/11/01 11:38:44 |
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Basic information
Public title
A multi institutional phase II study of oral fludarabine and rituximab (F-R therapy) for patients with relapsed or refractory mantle cell lymphoma.
Acronym
A phase II study of F-R therapy for relapsed or refractory mantle cell lymphoma.
Scientific Title
A multi institutional phase II study of oral fludarabine and rituximab (F-R therapy) for patients with relapsed or refractory mantle cell lymphoma.
Scientific Title:Acronym
A phase II study of F-R therapy for relapsed or refractory mantle cell lymphoma.
Region
| Japan |
Condition
Condition
Mantle cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of oral fludarabine and rituximab for relapsed/refractory mantle cell lymphoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Overall response rate (ORR)
Key secondary outcomes
Complete response rate(%CR), progression-free survival (PFS), overall survival (OS), response rate with PET/CT scan
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
Chemotherapy (6 cycles of F-R therapy)
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion Criteria:
(1) Pathohistological diagnosis of mantle cell lymphoma
(2) Positive for cyclin D1 in cell nucleus by immunohisitochemical analysis
(3) Positive for CD5 and CD20 in lymphoma cells by flowcytometry or immunohistochemistry
(4) Having evaluable lesion
(5) Relapsed or refractory to previous immuno-chemotherapy
(6) Interval of more than 4 weeks from previous chemotherapy
(7) Predictive survival time of at least 3 months
(8) Age: 20-79
(9) Performance status (PS): 0-2
(10) No major organ dysfunction
(11) Patient's written informed consent
Key exclusion criteria
(1) Documented infection including viral infection
(2) Sever comorbidity such as hear failure, hepatic failure or kidney failure
(3) Serious GI tract symptoms such as severe nausea, vomiting or diarrhea
(4) Positive test for HBs antigen
(5) Positive test for HCV antibody
(6) Positive test for HIV antibody
(7) Serious bleeding tendency such as DIC
(8) CNS involvement
(9) Non-tumor fever (>38.0 C)
(10) Interstitial pneumonitis or pulmonary fibrosis
(11) Active double cancer that needs therapy
(12) Autoimmune hemolytic anemia (AIHA) or previous history with AIHA
(13) Administration of G-CSF or blood transfusion within one week before enrollment
(14) Use of un-approved medicine within 3 months before enrollment
(15) Previous history of fludarabine
(16) Allergic reaction to purine nucleoside analogues
(17) Serious hypersensitivity or anaphylaxis to rituximab or mouse protein containing products
(18) History of allogeneic hematopoietic stem cell transplantation
(19) History of monoclonal antibody therapy other than rituximab or ibritumomab tiuxetan
(20) Pregnant, possible pregnant, or lactating women
(21) Refusal to contraception
(22) Other ineligibilities to this study judged by doctor in charge
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michinori Ogura |
Organization
Nagoya Daini Red Cross Hospital
Division name
Department of Hematology & Oncology
Zip code
Address
Myokencho 2-9, Showaku, Nagoya
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hematological Malignancy Clinical Study Group
Division name
Hematological Malignancy Clinical Study Group
Zip code
Address
TEL
052-832-1121
Homepage URL
Sponsor or person
Institute
Hematological Malignancy Clinical Study Group
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
| 2008 | Year | 10 | Month | 11 | 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
No longer recruiting
Date of protocol fixation
| 2008 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | 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 | 10 | Month | 08 | Day |
Last modified on
| 2013 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001727
