UMIN-CTR Clinical Trial

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

Follicular lymphoma

Classification by specialty

Hematology and clinical oncology	Radiology	Laboratory medicine

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Eisai Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

04

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2014

Year

04

Month

18

Day

Last modified on

2019

Year

04

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016055