UMIN-CTR Clinical Trial

Public 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.

Acronym

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.

Scientific 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.

Scientific Title:Acronym

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

non-Hodgkin's lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Response Rate

Key secondary outcomes

Complete Response Rate
Event-Free Survival
Progression-Free Survival
Safety
Completion Rate

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Masafumi Taniwaki

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Hematology and Oncology,

Zip code

Address

465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan

TEL

075-251-5740

Email

taniwaki@koto.kpu-m.ac.jp

Name of contact person

1st name
Middle name
Last name	Tsutomu Kobayashi

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Hematology and Oncology,

Zip code

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

Institute

Kyoto Prefectural University of Medicine
Department of Hematology and Oncology,

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2014

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2013

Year

12

Month

20

Day

Date of IRB

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

Other related information

Registered date

2014

Year

04

Month

01

Day

Last modified on

2018

Year

04

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015877