UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II trial of GDP therapy (gemcitabine, cisplatin and dexamethasone) in patients with refractory or recurrence non-Hodgkin's lymphoma having a history of more than 2 regimens.
Title of the study (Brief title)	Phase II trial of GDP therapy (gemcitabine, cisplatin and dexamethasone) in patients with refractory or recurrence non-Hodgkin's lymphoma having a history of more than 2 regimens.
Region	Japan

Condition
Condition	non-Hodgkin's lymphoma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of GDP therapy in Japanese patients with refractory or recurrence Non-Hodgkin lymphoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Response Rate
Key secondary outcomes	Complete Response Rate Event-Free Survival Progression-Free Survival Safety Completion Rate

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	Gemcitabine1,000mg/m2(day1,8) Cisplatin 25mg/m2(day1,8) Dexamethasone 8mg/body(day1,2,8,9) Rituximab 8mg/body(day1,8) (CD20 antigen is expressed) to be repeated every 3 weeks
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1. Histologically confirmed Non-Hodgkin lymphoma. 2. History of treatment more than 2 regimens. 3. Measurable lesion (diameter> 1.5cm). 4. Age 20-79 years. 5. ECOG performance status of 0-1. 6. Adequate organ function. Neutrophil : >=1,500/mm3 Platelet : >= 10,000/mm3 Hb : >= 8.0 mg/dl AST, ALT : >= 100IU mg/L T.bil.: <= 2.0 mg/dl Creatinin : <= 1.2mg/dl (or 24 hr CCr >= 60ml/min) SpO2 : >= 90% 7. Life expectancy of more than 3 month. 8. Signed written informed consent.
Key exclusion criteria	1. Interstitial pneumonitis or pulmonary fibrosis. 2. Prior radiotherapy for the lungs. 3. Uncontrollable diabetes. 4. Uncontrollable heat disease. 5. Uncontrollable infection. 6. History of severe drug allergy. 7. Severe renal disorder. 8. Large quantity of pleural, abdominal or cardiac effusion. 9. Positive for HBs antigen. 10. Positive for HCV antibody. 11. Severe mental disease. 12. Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval. 13. Women who are pregnant or breastfeeding. Men/women who are unwilling to avoid pregnancy. 14. Inadequate for study enrollment by the physician.
Target sample size	30

Research contact person
Name of lead principal investigator	Masafumi Taniwaki
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Hematology and Oncology,
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL	075-251-5740
Email	taniwaki@koto.kpu-m.ac.jp

Public contact
Name of contact person	Tsutomu Kobayashi
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Hematology and Oncology,
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL	075-251-5740
Homepage URL
Email	t-koba@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine Department of Hematology and Oncology,
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	京都府立医科大学病院（京都府） 愛生会山科病院（京都府） 大津市民病院（滋賀県） 京都第一赤十字病院（京都府） 京都第二赤十字病院（京都府） 社会保険京都病院（京都府） 松下記念病院（大阪府） 近江八幡市立総合医療センター（滋賀県） 市立福知山市民病院（京都府）

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 12 Month 20 Day
Anticipated trial start date	2014 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 04 Month 01 Day
Last modified on	2018 Year 04 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015877