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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024841
Receipt No. R000028587
Scientific Title A comprehensive surveillance study on the patients with malignant lymphoma undergoing CODOX-M/IVAC regimen with or without rituximab.
Date of disclosure of the study information 2016/11/15
Last modified on 2016/11/15

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Basic information
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
Condition Malignant lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization National Cancer Center Research and Development Fund
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 11 Month 15 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
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 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
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

Management information
Registered date
2016 Year 11 Month 15 Day
Last modified on
2016 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028587

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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