UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009506
Receipt number R000010938
Scientific Title Cohort study of cytomegalovirus infection after rituximab containing-induction chemotherapy and autologous stem cell transplantation for B-cell-Non-Hodgkin's Lymphoma
Date of disclosure of the study information 2012/12/09
Last modified on 2012/12/09 01:46:35

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Basic information

Public title

Cohort study of cytomegalovirus infection after rituximab containing-induction chemotherapy and autologous stem cell transplantation for B-cell-Non-Hodgkin's Lymphoma

Acronym

Cohort study of cytomegalovirus infection after rituximab containing-induction chemotherapy and autologous stem cell transplantation for B-cell-Non-Hodgkin's Lymphoma

Scientific Title

Cohort study of cytomegalovirus infection after rituximab containing-induction chemotherapy and autologous stem cell transplantation for B-cell-Non-Hodgkin's Lymphoma

Scientific Title:Acronym

Cohort study of cytomegalovirus infection after rituximab containing-induction chemotherapy and autologous stem cell transplantation for B-cell-Non-Hodgkin's Lymphoma

Region

Japan


Condition

Condition

B-cell-Non-Hodgkin's Lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the influence of cytomegalovirus infection after rituximab containing-induction chemotherapy and autologus stem cell transplantation for B-cell-Non-Hodgkin's Lymphoma

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

CMV infection rate

Key secondary outcomes

Safety


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

Rituximab containing-regimen and autologous stem cell transplantation for the responded patients as CR, CRu, PR after rituximab containing-induction chemotherapy

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

20 years-old <=

Age-upper limit

70 years-old >

Gender

Male and Female

Key inclusion criteria

a)Age:20-69
b)PS(ECOG):0-2
c)High intermediate risk group(H-I) or high risk group(H) in untreated aggressive B-cell-NHL
Relapsed or resistant for chemotherapy, radiotherapy, monoclonal antibody
d)Pts who were previously treated with less than 2 regimens or prior radiotherapy at least 12 weeks before registration
e)Life expectancy at least 12 weeks
f)Pts must have normal marrow and organ function as defined below
1)Bone marrow function
WBC>=3000/mm3
or neutrophil count>=1000/mm3
Platelet count>=100,000/mm3
Hemoglobin>=8.0g/dl
2)Liver function
AST, ALT<=2.5xULN
Total bilirubin<=1.5xULN
3)Renal fuction
Serum creatinine <=1.5mg/dl
4)Cardiac function
Normal electrocardiogram and cardiac function(without severe heart failure or cardiac arrhythmia)
g)Pts who give a writen informed consent

Key exclusion criteria

a)Pts received allogeneic hematopoietic(hemopoietic) stem cell transplant or autologous stem cell transplantation greater than two times.
b)Pts received rituximab at least 8 weeks before registration.
c)Pts received chemotherapy or radiotherapy at least 4 weeks before registration(include induction chemotherapy supported with autologous stem cell transplantation).
d)Allergy for monoclonal antibody.
e)Pts who observed transformation at relapse.
f)Other malignant diseases including simultaneous cancer and disease free state within 5 years after treatment.
g)Presense of central nervous invasion(clinical).
h)Severe heart failure(New York Heart Association: classIII, IV).
i)Severe lung disease.
j)Severe infectious disease.
k)Positive test for HBs antigen, HCV antibody, HIV antigen, HIV antibody, HBc antibody, HBV-DNA.
l)Past history of glaucoma.
m)In-treatment diabetes mellitus with insulin.
n)Pts who underwent surgery that requires general anesthesia at least 4 weeks before registration.
o)Tumor cell>=25,000/mm3.
p)Pts are pregnant or lactating women.
q)Uncontrol of contraception at during the administration or at least 48 weeks after final dose.
r)Psychological disease or psychological symptom that seems to be difficult to partcipate in clinical trial.
s)Inadequate for clinical trial entry by the attending physicians.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Aiko Sawazaki

Organization

Ishikawa prefectural central hospital

Division name

Department of Hematology

Zip code


Address

Kuratsuki-Higashi 2-1, Kanazawa, Ishikawa, Japan

TEL

076-237-8211

Email



Public contact

Name of contact person

1st name
Middle name
Last name Aiko Sawazaki

Organization

Ishikawa prefectural central hospital

Division name

Department of Hematology

Zip code


Address

Kuratsuki-Higashi 2-1, Kanazawa, Ishikawa, Japan

TEL

076-237-8211

Homepage URL


Email



Sponsor or person

Institute

Kanazawa university

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


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

2012 Year 12 Month 09 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

2009 Year 06 Month 28 Day

Date of IRB


Anticipated trial start date

2012 Year 12 Month 09 Day

Last follow-up date

2015 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 12 Month 09 Day

Last modified on

2012 Year 12 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010938


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name