UMIN-CTR Clinical Trial

Public title

A comprehensive surveillance study on the patients with malignant lymphoma undergoing CODOX-M/IVAC regimen with or without rituximab.

Acronym

A comprehensive surveillance study on the patients with malignant lymphoma undergoing CODOX-M/IVAC regimen with or without rituximab.

Scientific Title

A comprehensive surveillance study on the patients with malignant lymphoma undergoing CODOX-M/IVAC regimen with or without rituximab.

Scientific Title:Acronym

A comprehensive surveillance study on the patients with malignant lymphoma undergoing CODOX-M/IVAC regimen with or without rituximab.

Region

Japan

Condition

Malignant lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

This study is aimed at evaluating the social life including quality of life and fertility after CODOX-M/IVAC with or without rituximab among the patients with newly diagnosed malignant lymphoma, focusing on subtypes with a predilection for Adolescent and Young Adult (AYA). Additionally, we clarify the efficacy of CODOX-M/IVAC regimen with or without rituximab from the aspect of long-term outcome.

Basic objectives2

Others

Basic objectives -Others

Evaluation of fertility and QOL

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Evaluation of fertility

Key secondary outcomes

Pregnancy among the patients with fertility preservation, Quality of life (SF-36), Social rehabilitation, Complications, Long-term prognostic analysis

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histological diagnosis of Burkitt lymphoma, Burkitt-like lymphoma in the REAL classification and B-cell lymphoma unclassifiable with features between diffuse large B-cell lymphoma and Burkitt lymphoma in the 2008 WHO lymphoma classification, and primary mediastinal large B-cell lymphoma.
2) Patients treated with CODOX-M/IVAC with or without rituximab as a first-line therapy between 2003 and 2015.
3) In the case of questionnaire investigation, 20 years of age and older in being at commencement of the study.

Key exclusion criteria

1) Patients who have a communication problem in Japanese.
2) Patients who are disqualified by their attending physician.
3) In the case of questionnaire investigation, patients undergoing second-line therapy except for additional radiation therapy for residual lesion after CODOX-M/IVAC with or without rituximab.

Target sample size

70

Name of lead principal investigator

1st name
Middle name
Last name	Dai Maruyama

Organization

National Cancer Center Hospital

Division name

Department of Hematology

Zip code

Address

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

TEL

+81-3-3542-2511

Email

dmaruyam@ncc.go.jp

Name of contact person

1st name
Middle name
Last name	Kosuke Toyoda

Organization

National Cancer Center Hospital

Division name

Department of Hematology

Zip code

Address

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

TEL

+81-3-3542-2511

Homepage URL

Email

ktoyoda@ncc.go.jp

Institute

National Cancer Center Hospital

Institute

Department

Personal name

Organization

National Cancer Center Research and Development Fund

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

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

Date of disclosure of the study information

2016

Year

11

Month

15

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

Enrolling by invitation

Date of protocol fixation

2016

Year

11

Month

15

Day

Date of IRB

Anticipated trial start date

2016

Year

11

Month

21

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1) Social life, including evaluation of fertility and social rehabilitation
2) Assessment of QOL, using SF-36
3) Complication after CODOX-M/IVAC with or without rituximab
4) Clinical information, containing prognosis

Registered date

2016

Year

11

Month

15

Day

Last modified on

2016

Year

11

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028587