UMIN-CTR Clinical Trial

Public title

Randomized phase II study of biweekly R-CHOP versus biweekly R-CHOP followed by CHASER as induction therapy for high-dose chemotherapy, LEED, and autologous stem-cell transplantation in poor-risk diffuse large B-cell lymphoma (JCOG0908, DLBCL-bi-R-CHOP/CHASER-LEED-rP2 )

Acronym

DLBCL-bi-R-CHOP/CHASER-LEED-rP2 (JCOG0908)

Scientific Title

Randomized phase II study of biweekly R-CHOP versus biweekly R-CHOP followed by CHASER as induction therapy for high-dose chemotherapy, LEED, and autologous stem-cell transplantation in poor-risk diffuse large B-cell lymphoma (JCOG0908, DLBCL-bi-R-CHOP/CHASER-LEED-rP2 )

Scientific Title:Acronym

DLBCL-bi-R-CHOP/CHASER-LEED-rP2 (JCOG0908)

Region

Japan

Condition

diffuse large B-cell lymphoma, including subtypes; lymphomatoid granulomatosis, grade 3; primary mediastinal (thymic) large B-cell lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Randomized phase II trial to compare biweekly RCHOP plus CHASER to biweekly RCHOP as an induction regimen for high-dose therapy, LEED, with autologous peripheral blood stem cell transplantation for patients with diffuse large B-cell lymphomas in the high-intermediate and high risk International Prognostic Index groups

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

2-year progression free survival rate

Key secondary outcomes

Overall response rate and complete response rate of both the entire treatment courses and the induction phases, 2-year and 5-year overall survival rate, 5-year progression free survival rate, adverse events, serious adverse events, and incidence rate of secondary malignancies

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

A: biweekly RCHOP 6 courses followed by LEED with autologous peripheral blood stem cell transplantation

Interventions/Control_2

B: Biweekly RCHOP 3 courses and CHASER 3 courses followed by LEED with autologous peripheral blood stem cell transplantation

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

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Histologically confirmed diffuse large B-cell lymphoma, including subtypes of T cell/histiocyte rich large B-cell lymphoma, primary cutaneous DLBCL leg type and EBV positive DLBCL of the elderly, lymphomatoid granulomatosis grade 3, and primary mediastinal (thymic) large B-cell lymphoma by the WHO classification 4th edition
2) Positive for CD20 in lymphoma cells by immunohistochemical or flowcytometric analysis
3) Aged 20 to 65 years old
4) Performance status (PS) of 0-2 on ECOG(Eastern Cooperative Oncology Group) scale
5) Stage III or IV disease, or stage II with bulky disease
6) High-intermediate or high risk group on AA-IPI (Age-adjusted International Prognostic Index) score
7) Lymphoma cells in peripheral blood <=10,000/mm3 within 14 days prior to registration
8) No testicular or central nervous system involvement
9) Having an measurable lesion
10) No previous history of chemotherapy, radiation therapy, interferon and/or antibody
11) Adequate hematological and major organ function
12) Written informed consent

Key exclusion criteria

1) History of glaucoma
2) Diabetes mellitus regularly treated with insulin or uncontrollable diabetes mellitus
3) Uncontrollable hypertension
4) Serious cardiac conditions such as coronary disease, myocardiopathy and/or heart failure that requires treatment, and/or arrhythmia treated with antiarrhythmic
5) Positive test for HBs antigen
6) Positive test for HCV antibody
7) Positive test for HIV antibody
8) Interstitial pneumonia, pulmonary fibrosis or severe pulmonary emphysema
9) Other active malignancies
10) Severe infection that requires systemic therapy
11) Fever above 38 degrees Celsius except related to B symptoms
12) Pregnant, possible pregnant, or breastfeeding woman
13) Psychological disease or condition that precludes participation in clinical trial

Target sample size

70

Name of lead principal investigator

1st name
Middle name
Last name	Kazuhito Yamamoto

Organization

Aichi Cancer Center

Division name

Department of Hematology and Cell Therapy

Zip code

Address

1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan

TEL

052-762-6111

Email

kyamamoto@aichi-cc.jp

Name of contact person

1st name
Middle name
Last name	Kazuhito Yamamoto

Organization

JCOG0908 Coordinating Office

Division name

Department of Hematology and Cell Therapy, Aichi Cancer Center

Zip code

Address

1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan

TEL

052-762-6111

Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立病院機構北海道がんセンター（北海道）
札幌北楡病院（北海道）
東北大学病院（宮城県）
秋田大学医学部（秋田県）
太田西ノ内病院（福島県）
群馬大学医学部附属病院（群馬県）
埼玉県立がんセンター（埼玉県）
埼玉医科大学総合医療センター（埼玉県）
国立がん研究センター東病院（千葉県）
千葉県がんセンター（千葉県）
国立がん研究センター中央病院（東京都）
杏林大学医学部（東京都）
がん・感染症センター都立駒込病院（東京都）
東京慈恵会医科大学附属病院（東京都）
東京慈恵会医科大学第三病院（東京都）
がん研究会有明病院（東京都）
NTT東日本関東病院（東京都）
東海大学医学部（神奈川県）
金沢医科大学（石川県）
福井大学医学部附属病院（福井県）
浜松医科大学（静岡県）
愛知県がんセンター中央病院（愛知県）
国立病院機構名古屋医療センター（愛知県）
名古屋大学医学部（愛知県）
名古屋市立大学病院（愛知県）
名古屋第二赤十字病院（愛知県）
愛知医科大学附属病院（愛知県）
豊田厚生病院（愛知県）
三重大学医学部（三重県）
滋賀県立成人病センター（滋賀県）
京都府立医科大学（京都府）
兵庫県立がんセンター（兵庫県）
広島大学病院（広島県）
国立病院機構四国がんセンター（愛媛県）
愛媛大学医学部附属病院（愛媛県）
国立病院機構九州がんセンター（福岡県）
福岡大学医学部（福岡県）
国立病院機構九州医療センター（福岡県）
産業医科大学（福岡県）
佐賀大学医学部（佐賀県）
国立病院機構長崎医療センター（長崎県）
佐世保市立総合病院（長崎県）
長崎大学病院（長崎県）
熊本大学医学部（熊本県）
国立病院機構熊本医療センター（熊本県）
大分県立病院（大分県）
鹿児島大学医学部・歯学部附属病院（鹿児島県）
今村病院分院（鹿児島県）
琉球大学医学部附属病院（沖縄県）

Date of disclosure of the study information

2010

Year

06

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2010

Year

06

Month

02

Day

Date of IRB

Anticipated trial start date

2010

Year

06

Month

25

Day

Last follow-up date

2024

Year

12

Month

25

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

06

Month

25

Day

Last modified on

2015

Year

02

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004501