UMIN-CTR Clinical Trial

Public title

Phase II study of R-CODOX-M/R-IVAC therapy for the patients with newly diagnosed primary mediastinal large B-cell lymphoma

Acronym

PMBL-R-CODOX-M/R-IVAC-P2

Scientific Title

Phase II study of R-CODOX-M/R-IVAC therapy for the patients with newly diagnosed primary mediastinal large B-cell lymphoma

Scientific Title:Acronym

PMBL-R-CODOX-M/R-IVAC-P2

Region

Japan

Condition

Primary mediastinal large B-cell lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate efficacy and safety of R-CODOX-M/R-IVAC therapy for newly diagnosed primary mediastinal large B-cell lymphoma

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Complete response rate

Key secondary outcomes

Progression-free survival, overall survival, incidence of adverse events, and utility of response criteria with FDG-PET/CT

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Treatment regimen consisted of alternating cycles of R-CODOX-M (rituximab, cyclophosphamide, vincristine, doxorubicin, and methotrexate) and R-IVAC (rituximab, ifosfamide, etoposide, and cytarabine) for a total of four cycles

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

18

years-old

<=

Age-upper limit

59

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Histological diagnosis of primary mediastinal large B-cell lymphoma, according to the WHO classification.
2) Newly diagnosed, previously untreated primary mediastinal large B-cell lymphoma (patients who received corticosteroids alone are eligible for this study).
3) Positive for CD20 in lymphoma cells by immunohistochemistry or flowcytometry.
4) Age 18-59 years.
5) Performance status (ECOG): 0-2.
6) Having evaluable lesion.
7) No major organ dysfunction.
8) Patient's written informed consent before registration.

Key exclusion criteria

1) Uncontrollable hypertension.
2) History of myocardial infarction or angina or cardiomyopathy.
3) HBs antigen positive, HCV antibody positive or HIV antibody positive.
4) Accompanying interstitial pneumonitis, pulmonary fibrosis, or severe emphysema (all apparently diagnosed by chest X-ray).
5) Severe infections.
6) Liver cirrhosis, either biopsy proven or clinically diagnosed.
7) Active double cancer: overlapping cancer or asynchronous cancer within 5 years. Carcinoma in situ, intramucosal cancers, and other equivalent lesions are not included for the active double cancer.
8) Women during pregnancy, lactation period or of childbearing potentials not using a reliable contraceptive method.
9) Use of major tranquilizer, antidepressant or antimanic, or severe psychosis.
10) History of allogeneic or autologous hematopoietic stem cell transplantation.

Target sample size

35

Name of lead principal investigator

1st name
Middle name
Last name	Takashi Watanabe

Organization

National Cancer Center Hospital

Division name

Hematology Division

Zip code

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.

TEL

81-3-3542-2511

Email

Name of contact person

1st name
Middle name
Last name	Dai Maruyama

Organization

National Cancer Center Hospital

Division name

Hematology Division

Zip code

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.

TEL

81-3-3542-2511

Homepage URL

Email

dmaruyam@ncc.go.jp

Institute

National Cancer Center Hospital

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

国立がん研究センター中央病院（東京都）

Date of disclosure of the study information

2010

Year

06

Month

22

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

Completed

Date of protocol fixation

2007

Year

05

Month

24

Day

Date of IRB

Anticipated trial start date

2007

Year

06

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

06

Month

21

Day

Last modified on

2013

Year

06

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004586