UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006513 |
|---|---|
| Receipt number | R000007719 |
| Scientific Title | Phase 1/2 study of the combination of Bendamustine and Rituximab for treatment of elderly relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma. |
| Date of disclosure of the study information | 2011/10/18 |
| Last modified on | 2011/10/10 15:34:26 |
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Basic information
Public title
Phase 1/2 study of the combination of Bendamustine and Rituximab for treatment of elderly relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma.
Acronym
Phase 1/2 study of Bendamustine and Rituximab for elderly relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma.
Scientific Title
Phase 1/2 study of the combination of Bendamustine and Rituximab for treatment of elderly relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma.
Scientific Title:Acronym
Phase 1/2 study of Bendamustine and Rituximab for elderly relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma.
Region
| Japan |
Condition
Condition
relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma.
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Patients: Elderly, relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphom
In the phase I trial, primary objective is to estimate the maximum tolerated dose(MTD) and recommended dose(RD) of bendamustine and rituxima.
In the phase II trial, primary objectives is to evaluate the efficacy and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase 1
recommended dose
dose limiting toxicity
maximum tolerated dose
overall response rate
Phase 2
overall response rate
Key secondary outcomes
Phase 1
overall response rate
Phase 2
complete response rate
progression-free survival
safty
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Bendamustine + Rituximab
Phase 1
Rituximab Day 1 375mg/m2/day Bendamustine Day 2, Day 3
level 1: 90mg/m2/day, every 28 days
level 2: 120mg/m2/day, every 28 days
*Rituximab is infused on Day 1 and Bendamustine
infused on Day 1,Day 2 after 2 cycles.
Phase 2
Domestic recommended dose decided by phase 1 part
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with pathologically confirmed indolent B-cell non-Hodgkin lymphoma or mantle cell lymphoma.
2. Patients had received prior treatment of rituximab in combination with chemotherapy (without corticosteroid alone) or antibody treatments that rituximab alone or ibritumomab tiuxetan, and were considered no response or relapse after CR or PR.
3. CD20 positive
4. Patients have measurable lesion that measured >=1.5cm in a single dimension by CT.
5. Patients aged >= 65 years.
6. PS(ECOG) 0-2
7. Patients meet all following standard
Absolute neutrophil count >= 1,500/mm3
Platelet count >= 100,000/mm3
AST and ALT < 2.5 times facility criteria.
Total bilirubin < 1.5 times facility criteria.
Creatinine < 1.5 times facility criteria.
Cardiac electro gram : no abnormality required treatment
SpO2 : >= 90%
8. Patients have a life expectancy > 3 months.
9. Written informed consent.
Key exclusion criteria
1. Patients are pregnant or lactating women.
Patients (<1 year after menopause, without surgical infertility) can't or will not use birth control during the treatment.
2. Patients have active other malignant diseases including simultaneous cancer and disease free state within 5 years after treatment for other cancer except curable intramural cancer by local treatment.
3. Patients have mental disease or disorder with difficulty in participating in the clinical trial.
4. HBs antigen positive
5. HCV antibody positive
6. HIV antibody positive
7. Patients have much tumor cell in peripheral blood (>=25,000/uL).
8. Patients received allogeneic hematopoietic [hemopoietic] stem cell transplant.
9. Patients have interstitial lung disease or fibroid lung.
10. Patients have CNS invasion.
11. Patients already received bendamustine treatment.
12. Patients are inappropriate for rituximab treatment.
13. Patients have severe allergic symptoms.
14. Inadequate for clinical trial entry by the attending physicians.
Target sample size
43
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Itaru Matsumura |
Organization
Kinki University School of Medecine
Division name
Division of Hematology
Zip code
Address
377-2 Ohnohigashi, Osakasayama, Osaka, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoichi Tatsumi |
Organization
Kinki University School of Medecine
Division name
Division of Hematology
Zip code
Address
377-2 Ohnohigashi, Osakasayama, Osaka, Japan
TEL
Homepage URL
Sponsor or person
Institute
Kinki University School of Medecine
Division of Hematology
Institute
Department
Personal name
Funding Source
Organization
Kinki University School of Medecine
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
| 2011 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 10 | Day |
Last modified on
| 2011 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007719
