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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name