UMIN-CTR Clinical Trial

Basic information
Public title	A clinical phase II study assessing the safety and efficacy of readministration of bendamustine monotherapy or bendamustine/rituximab for relapsed low grade B cell non-Hodgkin lymphoma or mantle cell lymphoma patients previously treated with bendamustine containing chemothearpy
Acronym	Assessment of the safety and efficacy of bendamustine retreatment
Scientific Title	A clinical phase II study assessing the safety and efficacy of readministration of bendamustine monotherapy or bendamustine/rituximab for relapsed low grade B cell non-Hodgkin lymphoma or mantle cell lymphoma patients previously treated with bendamustine containing chemothearpy
Scientific Title:Acronym	Assessment of the safety and efficacy of bendamustine retreatment
Region	Japan

Condition
Condition	low-grade B cell non-Hodgkin lymphoma, Mantle cell lymphoma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Overall response rate after 2 cycles of therapy
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall response rate after 2 cycles of thearpy
Key secondary outcomes	1. Best overall response rate 2. complete response rate 3. progression free survival 4. safety 5. safety and efficacy after each cycle of treatment

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	bendamustine monotherapy or bendamustine/rituximab therapy will be administered
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients who have been diagnosed as histologically confirmed low-grade B cell non-Hodgkin's lymphoma or mantle cell lymphoma 2. Patients who have received bendamustine containing chemothrapy 3. Patients who have maintained reponse(greater than PR) to previous bendamustine containing regimen for over 3 months 4. Patients with measurable disease 5. Patients over 20 years-old 6. ECOG PS of 0 - 2 7. Patients who fulfill the following criteria ANC > 1,000 /mm3 Hgb > 8.0g /dL Plt > 75,000 /mm3 AST, ALT < x2.5 ULN T-Bil <2.0 mg/dl Cr <2.0 mg/dl 8. Patients with a life expectancy of > 3 months 9. Patients who can give written informed consent to the study
Key exclusion criteria	1. patients who are pregnant/female patients who are unwilling to take prevention measures for contraception during treatment 2. patients with active cancer 3. patients wih mental illnesses that the treating physician judges difficult to participate in the study 4. patients with circulating tumor cells > 25,000 /uL 5. patients with severe allergic reaction to medication 6. patients with active infectious diseases 7. patients who are positive for HBs antigen or HBV-DNA 8. patients who are judged inadequate to participate in the study according to the treating physician
Target sample size	38

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takayuki Shimizu
Organization	Keio University School of Medicine
Division name	Division of Hematology
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	+81-3-3353-1211
Email	taka-sh@keio.jp

Public contact
Name of contact person	1st name Middle name Last name Koichi Murakami
Organization	Keio University School of Medicine
Division name	Division of Hematology
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	+81-3-3353-1211
Homepage URL
Email	k.murakami1020@a8.keio.jp

Sponsor
Institute	KEIO BRB Study Group
Institute
Department

Funding Source
Organization	N/A
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	2013 Year 06 Month 17 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	2013 Year 06 Month 03 Day
Date of IRB	2013 Year 03 Month 23 Day
Anticipated trial start date	2013 Year 06 Month 17 Day
Last follow-up date	2020 Year 06 Month 30 Day
Date of closure to data entry	2020 Year 08 Month 06 Day
Date trial data considered complete	2020 Year 08 Month 06 Day
Date analysis concluded	2020 Year 08 Month 06 Day

Other
Other related information

Management information
Registered date	2013 Year 06 Month 10 Day
Last modified on	2020 Year 12 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012783