UMIN-CTR Clinical Trial

Public title

Phase II study of gemcitabine, carboplatin and dexamethasone with or without rituximab for patients with relapsed or refractory non-Hodgkin's lymphoma

Acronym

GHG-GCD

Scientific Title

Phase II study of gemcitabine, carboplatin and dexamethasone with or without rituximab for patients with relapsed or refractory non-Hodgkin's lymphoma

Scientific Title:Acronym

GHG-GCD

Region

Japan

Condition

relapsed or refractory non-Hodgkin's lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate efficacy and safety of gemcitabine, carboplatin and dexamethasone with or without rituximab for patients with relapsed or refractory non-Hodgkin's lymphoma

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

complete response rate

Key secondary outcomes

overall response rate
overall survival
progression free survival
safety
peripheral blood stem cell harvest (transplant case)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

GCD +/- R therapy
Gemcitabine 1000mg/sqm Day 1,8
Carboplatin AUC5 Day 1
Dexamethasone 40mg Day 1-4
*if CD 20 is positive
Rituximab 375mg/sqm Day 8

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients have pathologically confirmed refractory or relapsed non-Hodgkin lymphoma.
2) Patients had received prior treatment of rituximab in combination with CHOP or THP-COP.
3) Patients aged >= 18 years.
4) ECOG performance status of 0-2
5) Patients have measurable lesion.
6) Patients without interstitial pneumonia or pulmonary fibrosis evidenced by chest X-ray and/or chest CT.
7) Patients have a life expectancy > 12 weeks.
8) Written informed consent.
9) Patients meet all following standard.
Absolute neutrophil count >= 1,000/mm3
Hemoglobin >= 8.0 g/dL
Platelet count >= 75,000/mm3
AST and ALT < 2.5 times facility criteria.
Total bilirubin < 2.5 times facility criteria.

Key exclusion criteria

1) Patients have CNS invasion.
2) HIV antibody positive.
3) Patients have interstitial pneumonia or pulmonary fibrosis evidenced by chest X-ray and/or chest CT.
4) Patients undergoing chest radiotherapy.
5) Patients have major heart/lung disorders, or uncontrolled diabetes mellitus.
6) Patients are pregnant or lactating women. Patients cannot or will not use birth control during the treatment.
7) Patients have active other malignant diseases.
8) Patients have severe allergic symptoms.
9) Patients have chemotherapy resistant lymphoma.
10) Inadequate for clinical trial entry by the attending physicians.

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Hisashi Tsurumi

Organization

Gifu University Hospital

Division name

First Department of Internal Medicine

Zip code

Address

1-1 Yanagido Gifu

TEL

058-230-6000

Email

htsuru@gifu-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Junichi Kitagawa

Organization

Gifu University Hospital

Division name

First Department of Internal Medicine

Zip code

Address

1-1 Yanagido Gifu

TEL

058-230-6000

Homepage URL

http://seesaawiki.jp/ghsg/

Email

jkitagawa1128@gmail.com

Institute

Gifu University Hospital

Institute

Department

Personal name

Organization

First Department of Internal Medicine, Gifu University Hospital

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

岐阜大学医学部附属病院（岐阜県）
岐阜県総合医療センター（岐阜県）
岐阜市民病院（岐阜県）
岐阜赤十字病院（岐阜県）
岐北厚生病院（岐阜県）
一宮市立木曽川市民病院（愛知県）
高山赤十字病院（岐阜県）

Date of disclosure of the study information

2014

Year

12

Month

19

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

Open public recruiting

Date of protocol fixation

2014

Year

10

Month

01

Day

Date of IRB

Anticipated trial start date

2014

Year

11

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

12

Month

19

Day

Last modified on

2014

Year

12

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018257