UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 2 study of Gemcitabine, Dexamethasone, and Cisplatin (GDP) therapy for refractory/relapsed malignant lymphoma.
Title of the study (Brief title)	Phase 2 study of Gemcitabine, Dexamethasone, and Cisplatin (GDP) therapy for refractory/relapsed malignant lymphoma.
Region	Japan

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

Objectives
Narrative objectives1	The objective of this study is to evaluate the efficacy and safety of Gemcitabine, Dexamethasone, and Cisplatin (GDP) therapy for refractry/relapsed malignant lymphoma.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Overall response rate
Key secondary outcomes	Progression free survival Overall complete response rate Adverse effect rate

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	Investigation for efficacy and safety of GDP therapy for refractory/relapsed malignant lymphoma.
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	1 Pathohistological diagnosed for malignant lymphoma 2 Relapsed/refractory disease 3 Patients approved by written informed consent with age:18-70 4 Performance status of 0-2 5 No major organ dysfunction
Key exclusion criteria	1 Neutrophils <1000/mm3 2 Platelet <75,000/mm3 3 Cre >1.5mg/dL 4 AST or ALT > 5xULN, T.Bil >2.0mg/dL 5 Angina pectoris, myocardial infarction, treatment required arrhythmia 6 Interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema 7 Patients with CNS invasion of lymphoma cells 8 Radiation therapy for thorax 9 Severe bacterial infection
Target sample size	30

Research contact person
Name of lead principal investigator	Kenichi Sawada
Organization	Akita University School of Medicine
Division name	Dept. of hematology
Address	1-1-1 Hondo, Akita, Akita, 010-8543 JAPAN
TEL	018-834-1111
Email	ksawada@doc.med.akita-u.ac.jp

Public contact
Name of contact person	Yoshihiro Kameoka
Organization	Akita University School of Medicine
Division name	Dept. of hematology
Address	1-1-1 Hondo, Akita, Akita, 010-8543 JAPAN
TEL	018-834-1111
Homepage URL
Email	ykameoka@doc.med.akita-u.ac.jp

Sponsor
Institute	TOHOKU HEMATOLOGY FORUM
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

Other administrative information
Date of disclosure of the study information	2013 Year 09 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 14 Day
Anticipated trial start date	2013 Year 10 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 09 Month 09 Day
Last modified on	2019 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013637