UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003867 |
|---|---|
| Receipt number | R000004653 |
| Scientific Title | Phase 1 study of fludarabine combined with rituximab followed by Zevalin for patients with relapsed or refractory indolent B cell lymphoma |
| Date of disclosure of the study information | 2010/07/05 |
| Last modified on | 2014/07/04 13:03:35 |
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Basic information
Public title
Phase 1 study of fludarabine combined with rituximab followed by Zevalin for patients with relapsed or refractory indolent B cell lymphoma
Acronym
Fludarabine combined with rituximab followed by Zevalin for patients with relapsed or refractory indolent B cell lymphoma
Scientific Title
Phase 1 study of fludarabine combined with rituximab followed by Zevalin for patients with relapsed or refractory indolent B cell lymphoma
Scientific Title:Acronym
Fludarabine combined with rituximab followed by Zevalin for patients with relapsed or refractory indolent B cell lymphoma
Region
| Japan |
Condition
Condition
Indolent B cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of fludarabine conbined with riutximab followed by Zevalin therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Periods from the initiation of Zevalin therapy to the time of bone marrow recovery, neutrophil count is more than 1000/mm3 and pletlet count is more than 50000/mm3.
Key secondary outcomes
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
As dose limiting toxicity, delayed bone marrow recovery is selected.
Delayed bone marrow recovery is defined that neutrophil count less than 1000/ mm3 or platelet count less than 50000/mm3 after 12 weeks of Zevalin therapy.
In FR therapy, rituximab at 375 mg/m2 is administered on day 1 of each treatment cycle along with oral dosing of fludarabine phosphate tablets once daily from day 1 through 5 every 28 days.
In level 1, treated with two courses of FR therapy followed by Zevalin therapy.
In level 2, treated with three courses of FR therapy followed by Zevalin therapy.
Evaluate three patients at level 1.
1) If zero of three have DLT, then go to level 2.
2) If one of three have DLT, then evaluate an additional three patients at level 1.
a)If one of six have DLT, then go to level 2.
b)If two of six have DLT, then level 1 is recommended.
c) If at least three of six have DLT, discontinue this trial.
3) If at least two of three have DLT, then discontinue this trial.
Evaluate six patients at level 2.
1) If two or less of six have DLT, level 2 is recommended.
2)If at least three of six have DLT, level 1 is recommended.
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
(a)Have had diagnosis of indolent B cell lymphoma
(b)Relapsed or refractory patients
(c)The number of previous chemotherapy regimens is two or less
(d)After rituximab more than 12 weeks
(e)After previous chemotherapy more than 4 weeks
(f)CD20 positive by flowcytometry or immunohistochemistory
(g)Aged 20 - 79
(h)PS 0 - 2
(i)Without CNS involvement
(j)Have measurable lesions(diameter more than 1.5cm)
(k)Have adequate organs functions
(l)Gave written informed consent
(m)Expectet survival period more than three manths
(n)Not pregnant or lactating
(o)Consent to contraception
Key exclusion criteria
(a)History of hematopoietic stem cell transplantation
(b)History of whole pelvic or whole abdomen radiation
(c)Received G-CSF or erythropoietin or transfusion less than one week before registration
(d)Taken an operation less than four weeks before registration
(e)History of Zevalin therapy
(f)History of the treatment of purin analogs
(g)Have active systemic infections
(h)Have a serious complication(cardiac dysfunction, hepatic failure, or renal failure)
(i)Have a serious digestive organ symptom
(j)Have a serious bleeding tendency
(k) Positive for HBs antigen, HCV antibody, or HIV antibody.
(l)Have an interstitial pneumonia or fibrosis
(m)Active cancers
(n)Have or history of autoimmune hemolytic anemia
(o)Have aglucoma
(p) Otherwise judged by investigator to be unsuitable
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideo Harigae |
Organization
Tohoku University Graduate School of Medicine
Division name
Hematology & Rheumatology
Zip code
Address
1-1 Seryou-machi, Aoba-ku Sendai
TEL
022-717-7165
kishizaw@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Ishizawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Hematology & Rheumatology
Zip code
Address
1-1 Seryou-machi, Aoba-ku Sendai
TEL
022-717-7165
Homepage URL
kishizaw@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku Hematology Form
Institute
Department
Personal name
Funding Source
Organization
Tohoku Hematology Form
Organization
Division
Category of Funding Organization
Other
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
| 2010 | Year | 07 | Month | 05 | 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
| 2009 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 07 | Month | 04 | Day |
Last modified on
| 2014 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004653
