UMIN-CTR Clinical Trial

Basic information
Public title	Phase 1/2 study of the combination of Bendamustine and Rituximab for treatment of relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma.
Acronym	Phase 1/2 study of Bendamustine and Rituximab for 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 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 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	In the phase I trial, primary objective is to estimate the maximum tolerated dose(MTD) and recommended dose(RD) of bendamustine and rituximab relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma. 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	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+Rituximab Phase 1 Rituximab Day1 375mg/m2/day Bendamustine Day2, Day3 Level 1: 90mg/m2/day, every 21 days Level 2: 90mg/m2/day, every 28 days Level 3: 120mg/m2/day, every 21 days Level 4: 120mg/m2/day, every 28 days Rituximab is infused on Day1 and Bendamustine infusedon Day1, Day2 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	20 years-old <=
Age-upper limit	75 years-old >
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 20-74 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 not 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/mm3). (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	40

Research contact person
Name of lead principal investigator	1st name Nozomi Middle name Last name Niitsu
Organization	International Medical Center, Saitama Medical University
Division name	Department of Hematology
Zip code	350-1298
Address	1397 - 1, Yamane, Hidaka, Saitama, Japan
TEL	042-984-4111
Email	ntakashi@saitama-med.ac.jp

Public contact
Name of contact person	1st name Naoki Middle name Last name Takahashi
Organization	International Medical Center, Saitama Medical University
Division name	Department of Hematology
Zip code	350-1298
Address	1397 - 1, Yamane, Hidaka, Saitama, Japan
TEL	042-984-4111
Homepage URL
Email	ntakashi@saitama-med.ac.jp

Sponsor
Institute	Department of Hematology, International Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization	Department of Hematology, International Medical Center, Saitama Medical University
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	IRB committee, International Medical Center, Saitama Medical University
Address	1397 - 1, Yamane, Hidaka, Saitama, Japan
Tel	042-984-4111
Email	chikens@saitama-med.ac.jp

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 04 Month 12 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 02 Month 01 Day
Date of IRB	2011 Year 02 Month 01 Day
Anticipated trial start date	2011 Year 02 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 04 Month 12 Day
Last modified on	2020 Year 04 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005907