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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003867
Receipt No. 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

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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
Email 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
Email kishizaw@med.tohoku.ac.jp

Sponsor
Institute Tohoku Hematology Form
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004653

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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