UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015492 |
|---|---|
| Receipt number | R000017988 |
| Scientific Title | Rituximab combined with gemcitabine, dexamethasone, and cisplatin in elderly patients with relapsed or refractory diffuse large B-cell lymphoma |
| Date of disclosure of the study information | 2015/01/05 |
| Last modified on | 2015/01/26 14:20:08 |
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Basic information
Public title
Rituximab combined with gemcitabine, dexamethasone, and cisplatin in elderly patients with relapsed or refractory diffuse large B-cell lymphoma
Acronym
Rituximab combined with gemcitabine, dexamethasone, and cisplatin in elderly patients with relapsed or refractory diffuse large B-cell lymphoma (EDL-GDP)
Scientific Title
Rituximab combined with gemcitabine, dexamethasone, and cisplatin in elderly patients with relapsed or refractory diffuse large B-cell lymphoma
Scientific Title:Acronym
Rituximab combined with gemcitabine, dexamethasone, and cisplatin in elderly patients with relapsed or refractory diffuse large B-cell lymphoma (EDL-GDP)
Region
| Japan |
Condition
Condition
Diffuse large B-cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Japanese relapsed or refractory patients aged over 65 years with diffuse large B-cell lymphoma will have rituximab combined with gemcitabine, cisplatine and dexamethasone.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
response rate (CR and PR)
Key secondary outcomes
toxicity
2 year progression-free survival
2 year overall survival
time to response
quality of life
hospitalization rates
economic analysis
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
multi-center, single arm open label Phase II clinical study
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients older than 65 years of age.
2) Tissue diagnosis for diffuse large B-cell lymphoma (DLBCL, ccording to the World Health Organization), documented at initial diagnosis or at relapse. Biopsy proof at relapse is desirable but not mandatory.More than 3 cycles of rituximab in combination with chemotherapy for prior DLBCL.
3) CD20 positive either at diagnosis or relapse.
4) Measurable disease is defined.
5) ECOG performance status 0, 1 or 2.
6) Laboratory Requirements:
Absolute granulocytes > 1.0 x 10^9/L,Platelets > 50 x 10^9/L,
LV ejection fraction of > 50 %
Pulmonary sufficiency (PaO2 >60mmHg or sPO2 >93% on room air), AST or ALT < 5 x ULN, Creatinine clearance > 30 ml/min
7) Patient is able and willing to complete the quality of life questionnaires in validated translations. Inability (illiteracy, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible.
Key exclusion criteria
Patients who fulfill any of the following criteria are not eligible for admission to the study:
1) B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and Burkitt lymphoma (intermediate DLBCL/BL) or Burkitt lymphoma
2) Testicular lymphoma or central nervous system involvement by lymphoma. Patients diagnosed with CNS disease at the time of relapse (on-study) are not eligible. Patients diagnosed with CNS disease at
initial presentation who achieved and maintained CNS CR at the time of relapse are eligible. Lumbar
puncture must be done in this case prior to study entry to demonstrate CNS CR status.
Tests to investigate CNS involvement are required otherwise only if clinically indicated.
3) Uncontrolled liver, kidney, cardiac or pulmonary dysfunction, or diabetes mellitus or hypertension.
4) Interstitial lung disease or pulmonary fibrosis.
5) Uncontrolled bacterial, fungal, or viral infection.
6) Patients with a history of cardiac dysfunction or cardiovascular disease (< 6 months at diagnosis).
7) Patients with a history of other malignancies, except: curatively treated in-situ cancer of the cervix, stomach, or colon, or other solid tumours curatively treated with no evidence of disease for > 5 years.
8) Positive for HBs-Ag, HCV-Ab, and/or HIV-Ab.
9) Drug hypersensitivity syndrome.
10) Patient is not able and willing to complete the consensus.
11) Other serious intercurrent illness or medical condition judged by the local investigator to preclude safe administration of the planned protocol treatment.
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | SATOSHI YAMASAKI |
Organization
National Hospital Organization Kyushu Medical Center
Division name
Department of Hematology and Clinical Research Institute
Zip code
Address
1-8-1 Jigyohama, Chuo-Ku, Fukuoka 810-8563, Japan
TEL
092-852-0700
yamas009@kyumed.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | SATOSHI YAMASAKI |
Organization
National Hospital Organization Kyushu Medical Center
Division name
Department of Hematology and Clinical Research Institute
Zip code
Address
1-8-1 Jigyohama, Chuo-Ku, Fukuoka 810-8563, Japan
TEL
092-852-0700
Homepage URL
yamas009@kyumed.jp
Sponsor or person
Institute
National Hospital Organization Kyushu Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2015 | Year | 01 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 21 | Day |
Last modified on
| 2015 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017988
