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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018291
Receipt No. R000021171
Scientific Title Efficacy of GDP regimen for relapsed/refractory B-NHL (Phase II)
Date of disclosure of the study information 2015/07/13
Last modified on 2019/03/29

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Basic information
Public title Efficacy of GDP regimen for relapsed/refractory B-NHL (Phase II)
Acronym GDP-P2(Jikei)
Scientific Title Efficacy of GDP regimen for relapsed/refractory B-NHL (Phase II)
Scientific Title:Acronym GDP-P2(Jikei)
Region
Japan

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

Objectives
Narrative objectives1 To investigate efficacy and safety of GDP regimen for relapsed/refractory B-NHL
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Overall response rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 GDP regimen
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
20 years-old <=
Age-upper limit
74 years-old >=
Gender Male and Female
Key inclusion criteria 1) Pathological diagnosis of B-NHL
2) Age: 20-74
3) Performance status(ECOG): 0-2
4) Recognition of relapse by CT-scan, or refractory to previous chemotherapy
5) Previous chemotherapeutic regimen: over 1 regimen
6) No history of administration of platinum
7) No CNS involvement of B-NHL
8) Have measurable lesions of B-NHL
9) Informed consent by patient
Key exclusion criteria 1) Uncontrolable diabetes mellitus by insulin therapy
2) Uncontrolable hypertension. Coronary disease, cardiomyopathy, cardiac failure, arhythmia that needs drug therapy.
3) HBs-Ag, HCV-Ab, HIV-Ab: positive
4) Interstitial pneumonia, pulmonary fibrosis
5) Severe infection
6) Double cancer in active
7) Pregnancy, possibility of pregnancy, in breast-feeding
8) Psyciatric disease
9) Continuous systemic administration of steroid
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaro Kamiyama
Organization The Jikei university school of medicine
Division name Oncology and hematology
Zip code
Address 3-19-18 Nishi-shinbashi Minato-ku, Tokyo, Japan
TEL +81-3-3433-1111
Email stasia@jikei.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yutaro Kamiyama
Organization The Jikei university school of medicine
Division name Oncology and hematology
Zip code
Address 3-19-18 Nishi-shinbashi Minato-ku, Tokyo, Japan
TEL +81-3-3433-1111
Homepage URL
Email stasia@jikei.ac.jp

Sponsor
Institute The Jikei university school of medicine, Oncology and hematology
Institute
Department

Funding Source
Organization The Jikei university school of medicine, Oncology and hematology
Organization
Division
Category of Funding Organization Self funding
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 東京慈恵会医科大学附属病院,同第三病院,同柏病院

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 13 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 Completed
Date of protocol fixation
2014 Year 08 Month 18 Day
Date of IRB
2014 Year 06 Month 02 Day
Anticipated trial start date
2014 Year 11 Month 07 Day
Last follow-up date
2021 Year 03 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 07 Month 13 Day
Last modified on
2019 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021171

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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