UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001570 |
|---|---|
| Receipt number | R000001893 |
| Scientific Title | A phase II study of the Cladribine and Rituximab combination therapy for relapsed and refractory indolent B-cell Non-Hodgkin's Lymphoma. |
| Date of disclosure of the study information | 2008/12/18 |
| Last modified on | 2008/12/12 16:55:18 |
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Basic information
Public title
A phase II study of the Cladribine and Rituximab combination therapy for relapsed and refractory indolent B-cell Non-Hodgkin's Lymphoma.
Acronym
A phase II study of Cladribine and Rituximab therapy for relapsed indolent B-cell Non-Hodgkin's Lymphoma.
Scientific Title
A phase II study of the Cladribine and Rituximab combination therapy for relapsed and refractory indolent B-cell Non-Hodgkin's Lymphoma.
Scientific Title:Acronym
A phase II study of Cladribine and Rituximab therapy for relapsed indolent B-cell Non-Hodgkin's Lymphoma.
Region
| Japan |
Condition
Condition
low grade B cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The object of this clinical trial is to examine the efficacy and safety of cladribne and rituximab combination therapy for relapsed or refractory CD20 positive low grade B cell lymphoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
complete response rate, 2 years progression free survival, 2 years overall survival, time to best response, duration of remission, 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 |
Interventions/Control_1
Cladribine 0.09mg/kg (day1-5) combined with Rituximab 375mg/m2 (day 1 and 15) is administrated every 4 weeks (total 4 cycles).
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.pathological diagnosis: low grade B cell lymphoma.
2.CD20 antigen positive.
3.presence of mesurable lesions.
4.relapsed case after previous systemic chemotherapies.
5.washout duration from previous chemotherapy: more than 4 weeks after systemic chemoterapy and more than 3 months after rituximab treatment.
6.at least 3 months of life expectancy.
7.PS(ECOG): 0-2.
8.adequate organ function.
9.informed consented patients for this clinical trial.
Key exclusion criteria
1.previous exposures of cladribine, fludarabine, or pentostatin.
2.treatment histories of more than one allogenic stem cell transplantasion or more than 2 times of autologous stem cell transplantation.
3.transformed case at registration.
4.past history of glaucoma.
5.presence of active infection.
6.HBs Ag posivtive, HCV Ab positive, HIV Ab positive.
7.presence of lymphoma cells more than 5000/mm3 in periperal blood.
8.past history of severe drug allergy.
9.presence of other active malignancy.
10.diabetis melitus recieving insulin therapy.
11.severe mental disorder.
12.autoimmune hemolytic anemia.
13.severe bleeding tendency.
14.recieving CSF or blood transfusion within 2 weeks of registration.
15.presence of central nervous involvement (clinical or pathological).
16.pregnant or feeding female.
17.recieving unapproved anti cancer agents within 3 months of registration.
18.judged for inappropriate by other reasons.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TOMOMITSU HOTTA |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Hospital
Zip code
Address
4-1-1, Sannomaru, Naka-ku, Nagoya
TEL
052-951-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | HIROKAZU NAGAI |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Clinical Research Center
Zip code
Address
4-1-1, Sannomaru, Naka-ku, Nagoya
TEL
052-951-1111
Homepage URL
nagaih@nnh.hosp.go.jp
Sponsor or person
Institute
refractory lymphoma treatment 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 | 12 | Month | 18 | 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
| 2004 | Year | 10 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 12 | Month | 12 | Day |
Last modified on
| 2008 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001893
