UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006513
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute Kinki University School of Medecine
Division of Hematology
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007719

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.