UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011682 |
|---|---|
| Receipt number | R000013637 |
| Scientific Title | Phase 2 study of Gemcitabine, Dexamethasone, and Cisplatin (GDP) therapy for refractory/relapsed malignant lymphoma. |
| Date of disclosure of the study information | 2013/09/09 |
| Last modified on | 2019/01/28 10:58:17 |
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Basic information
Public title
Phase 2 study of Gemcitabine, Dexamethasone, and Cisplatin (GDP) therapy for refractory/relapsed malignant lymphoma.
Acronym
Phase 2 study of Gemcitabine, Dexamethasone, and Cisplatin (GDP) therapy for refractory/relapsed malignant lymphoma.
Scientific Title
Phase 2 study of Gemcitabine, Dexamethasone, and Cisplatin (GDP) therapy for refractory/relapsed malignant lymphoma.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kenichi Sawada |
Organization
Akita University School of Medicine
Division name
Dept. of hematology
Zip code
Address
1-1-1 Hondo, Akita, Akita, 010-8543 JAPAN
TEL
018-834-1111
ksawada@doc.med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Kameoka |
Organization
Akita University School of Medicine
Division name
Dept. of hematology
Zip code
Address
1-1-1 Hondo, Akita, Akita, 010-8543 JAPAN
TEL
018-834-1111
Homepage URL
ykameoka@doc.med.akita-u.ac.jp
Sponsor or person
Institute
TOHOKU HEMATOLOGY FORUM
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 14 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013637
