UMIN-CTR Clinical Trial

Basic information
Public title	Anti-tumor effect and safety of GDP therapy (gemcitabine, dexamethasone, and cisplatin) in patients with relapsed or refractory non-Hodgkin lymphoma
Acronym	Anti-tumor effect and safety of GDP therapy (gemcitabine, dexamethasone, and cisplatin) in patients with relapsed or refractory non-Hodgkin lymphoma
Scientific Title	Anti-tumor effect and safety of GDP therapy (gemcitabine, dexamethasone, and cisplatin) in patients with relapsed or refractory non-Hodgkin lymphoma
Scientific Title:Acronym	Anti-tumor effect and safety of GDP therapy (gemcitabine, dexamethasone, and cisplatin) in patients with relapsed or refractory non-Hodgkin lymphoma
Region	Japan

Condition
Condition	relapsed or refractory non-Hodgkin lymphoma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Therapeutic efficacy and safety of GDP therapy (Gemcitabine, Dexamethasone, and Cisplatin) have not ever been estimated in this country. Improvement in overall survival and progression free survival by GDP therapy can generate another therapeutic choice in relapsed or refractory no Hodgkin lymphoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Promary endpoint Overall responsive rate Primary endpoint is determined to be an overall responsive rate of GDP therapy evaluated according to IWRC.
Key secondary outcomes	Secondary endpoints 1) CRrate 2) Progression free survival 3) Therapeutic efficacy and safety of GDP therapy are estimated compared with those of historical control. 4) Adverse effect

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Gemcitabine 1000mg/m2, Day1, 8 Dexamethasone 40mg/body, Day1-4 Cisplatin 75mg/m2, Day1 Rituximab 375mg/m2, Day1, 8 Up to 8 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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	1) non-Hodgkin lymphoma(aged 20 or older) 2) measurable lesion(s) 3) antecedent treatment(s) 4) 6 months or more in estimated survival 5) 0-2 in Performance Status 6) well preserved organic function 7) written consent
Key exclusion criteria	1) Received a gemcitabine previously 2) Allergic experience to rituximab or mouse proteins in the case of administration of rituximab 3) Pulmonary fibrosis or interstitial pneumonia detected within 28 days 4) Serious heart disease 5) Serious digestive symptoms 6) Body cavity fluid requiring treatment 7) Severe bone marrow suppression 8) Active infection 9) Serologically positive for HBsAg, HCVAb, or HIVAb 10) Severe bleeding tendency 11) Symptomatic brain metastasis 12) Critical complication 13) Serious mental disease 14) Active malignancy concomitantly existed 15) Auto immune hemolytic anemia 16) Lactating women, pregnant women and women suspected of being pregnant 17) Disagreement on intercourse without contraception 18) Ineligibility owing to the decision of doctor involved in this trial
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Tatsuo Middle name Last name Ichinohe
Organization	Research Institute for Radiation Biology and Medicine
Division name	Dept of Hematology and Oncology
Zip code	734-8553
Address	1-2-3 Kasumi Minami-ku Hiroshima, Japan
TEL	082-257-5555
Email	nohe@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Keichiro Middle name Last name Mihara
Organization	Hiroshima University
Division name	Dept of Hematology and Oncology
Zip code	734-8553
Address	1-2-3 Kasumi Minami-ku Hiroshima, Japan
TEL	082-257-5555
Homepage URL
Email	kmmihara@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

Funding Source
Organization	Hiroshima University
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	Hiroshima University
Address	1-2-3 Kasumi Minami-ku Hiroshima Japan
Tel	028-257-5555
Email	byo-keiei-tiken@office.hiroshima-u.ac.jp

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	2013 Year 09 Month 01 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	2013 Year 09 Month 01 Day
Date of IRB	2012 Year 06 Month 01 Day
Anticipated trial start date	2013 Year 09 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 08 Month 30 Day
Last modified on	2021 Year 08 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013098