UMIN-CTR Clinical Trial

Basic information
Public title	A prospective study of the predictive capabilities of 18[F]-FDG-PET in patients with first relapsed/refractory follicular lymphoma following treatment with Bendamustine+Rituximab therapy
Acronym	W-JHS NHL01 study
Scientific Title	A prospective study of the predictive capabilities of 18[F]-FDG-PET in patients with first relapsed/refractory follicular lymphoma following treatment with Bendamustine+Rituximab therapy
Scientific Title:Acronym	W-JHS NHL01 study
Region	Japan

Condition
Condition	Follicular lymphoma
Classification by specialty	Hematology and clinical oncology Radiology Laboratory medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate 1-year progression free survival (1-yr PFS) between PET positive and PET negative in effect measurement using standardized FDG-PET/CT after the combination treatment of bendamustine hydrochloride and rituximab (BR therapy) in patients with first relapse or recurrent follicular lymphoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1-year progression free survival(1-yr PFS)
Key secondary outcomes	- Overall response rate (ORR) - Complete response rate (CRR) - 1 year overall survival (1-yr OS) - Event free survival (EFS) - Safety - Relationship between SUV max in standardized PET and response rate/PFS - Relationship between delta SUV and PFS in standardized PET conduct case before 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 Device,equipment
Interventions/Control_1	The administration of bendamustine hydrochloride is conducted for 28 days as 1 course and infused 90 mg/m2 in day 1 and day 2 (or day 2 and day 3) and discontinued until day 28. Rituximab is administered 375 mg/m2 every 28 days on the first day. The combination therapy mentioned above (BR therapy) is conducted for 28 days as 1 course. The treatment is continued 6 courses unless adverse events and clear disease progression hard to continue appeared and conflict with a discontinuation criteria. Attending physician judge positive/ negative based on the central image diagnosis result by the evaluation of FDG-PET/CT for a patient except clinically clear progressive disease (PD) in effect measurement. The imaging of FDG-PET/CT is conducted before (if possible) and after (essential) treatment to check delta SUV, etc. It should be treatment free follow-up for one year until PD after BR therapy. Follow-up treatment is chosen by an attending physician's judgement at the time of the progression. The follow-up CT is photographed at 12th month and 18th month later from the registration date.
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 with first relapse or recurrent follicular lymphoma (grade1-3a), with treatment history of one regimen of chemotherapy or rituximab. (cf. radiation therapy and steroid treatment alone are not regarded as one regimen.) 2) Patients who were diagnosed as pathologically follicular lymphoma in histological diagnosis at onset. 3) Patients who relapsed after complete response (CR) or a recurred after partial response (PR) by immunotherapy, chemotherapy (adrenocortical hormone monotherapy is excluded) or immunochemotherapy. (not matter for the stage of disease) 4) Patients who had 4wks washout period from the former treatment of anticancer drug (2 months washout period in the case of rituximab and ibritumomab tiuxetan). 5) Patients with CD20 positive (initial visit and visit with relapse) 6) Patients with measurable legion (CT minor axis >1.0cm). 7) Both genders at more than 20 years old (age at registration). 8) ECOG Performance Status 0-2 (PS3 is eligible when it is caused by a lymphoma) 9) Patients meet following all criteria within 2 weeks before registration. - Neutrophil >=1,000/mm^3 - Hemoglobin >=8.0g/dL - Platelets >=75,000/mm^3 - AST and ALT <= 3x ULN (eligible when the permeation of lymphoma is regarded as the cause of the liver damage) - Total bilirubin <=2.0mg/dL (eligible when the permeation of lymphoma is regarded as the cause of the liver damage) - Creatinine <=2.0mg/dL - Ejection fraction >=50% - PaO2 >=60mmHg (or SpO2 >=90%) without oxygen inhalation 10) Patients with more than 3 months survival. 11) Patients providing written informed consent.
Key exclusion criteria	1) Patients who were determined histologic transformation by biopsy in recurrence (not mandatory). 2) Patients with histological grade 3b. 3) Patients with former treatment of radiation therapy or steroid treatment alone. 4) Pregnant or lactating women. Female patients of childbearing potential, or cannot use or not intent to use an appropriate sterilization within 1year under menopause during a treatment period. 5) Patients with active double cancer (simultaneous double cancer and disease free period of allochronic double cancer is within 5 years. Basal cell cancer, squamous carcinoma, carcinoma in situ judged to be cured by local treatment, and lesion correspond to intramucosal carcinoma are not included in active double cancer.) 6) Patients who are judged to have difficulty in study participation by complication with mental disease or mental manifestation. 7) Patients with HBs antigen positive (cf. patients with HBs antibody and HBc antibody positive are not excluded, but patients who are detected HBV-DNA are excluded.) 8) Patients with HIV antibody positive. 9) Patients with autologous and allogeneic hematopoietic stem cell transplantation 10) Patients with comorbidity of interstitial pneumonia, radiation pneumonia and pulmonary fibrosis checked by a chest CT (within 3 months before registration). 11) Patients with infiltration to CNS. 12) Patients who had received bendamustine or judged to be inadequate of bendamustine administration 13) Patients with severe drug hypersensitivity. 14) Any other patients who are regarded as unsuitable for study enrollment by the investigators
Target sample size	65

Research contact person
Last name of lead principal investigator	1st name Junji Middle name Last name Suzumiya
Organization	Shimane University Hospital
Division name	Cancer Center
Zip code	693-8501
Address	Enyacho 89-1, Izumo-city, Shimane, 693-8501 Japan
TEL	0853-20-2308
Email	suzumiya@med.shimane-u.ac.jp

Public contact
1st name of contact person	1st name Tsutomu Middle name Last name Takahashi
Organization	Shimane University Hospital
Division name	Cancer Center
Zip code	693-8501
Address	Enyacho 89-1, Izumo-city, Shimane, 693-8501 Japan
TEL	0853-20-2308
Homepage URL
Email	ben2106t@med.shimane-u.ac.jp

Sponsor
Institute	Cooperative study between the West Japan Hematology Study Group and Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization	Eisai Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Shimane University Institutional Committee on Ethics
Address	Enyacho 89-1, Izumo-city, Shimane, 693-8501 Japan
Tel	0853-23-2111
Email	mga-kikaku@office.shimane-u.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	2014 Year 04 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	75
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	No longer recruiting
Date of protocol fixation	2014 Year 03 Month 14 Day
Date of IRB	2013 Year 02 Month 26 Day
Anticipated trial start date	2014 Year 04 Month 18 Day
Last follow-up date	2019 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 04 Month 18 Day
Last modified on	2019 Year 04 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016055