Unique ID issued by UMIN | UMIN000009506 |
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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 |
Cohort study of cytomegalovirus infection after rituximab containing-induction chemotherapy and autologous stem cell transplantation for B-cell-Non-Hodgkin's Lymphoma
Cohort study of cytomegalovirus infection after rituximab containing-induction chemotherapy and autologous stem cell transplantation for B-cell-Non-Hodgkin's Lymphoma
Cohort study of cytomegalovirus infection after rituximab containing-induction chemotherapy and autologous stem cell transplantation for B-cell-Non-Hodgkin's Lymphoma
Cohort study of cytomegalovirus infection after rituximab containing-induction chemotherapy and autologous stem cell transplantation for B-cell-Non-Hodgkin's Lymphoma
Japan |
B-cell-Non-Hodgkin's Lymphoma
Hematology and clinical oncology |
Malignancy
NO
To evaluate the influence of cytomegalovirus infection after rituximab containing-induction chemotherapy and autologus stem cell transplantation for B-cell-Non-Hodgkin's Lymphoma
Safety
Exploratory
Explanatory
Not applicable
CMV infection rate
Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Rituximab containing-regimen and autologous stem cell transplantation for the responded patients as CR, CRu, PR after rituximab containing-induction chemotherapy
20 | years-old | <= |
70 | years-old | > |
Male and Female
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
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.
30
1st name | |
Middle name | |
Last name | Aiko Sawazaki |
Ishikawa prefectural central hospital
Department of Hematology
Kuratsuki-Higashi 2-1, Kanazawa, Ishikawa, Japan
076-237-8211
1st name | |
Middle name | |
Last name | Aiko Sawazaki |
Ishikawa prefectural central hospital
Department of Hematology
Kuratsuki-Higashi 2-1, Kanazawa, Ishikawa, Japan
076-237-8211
Kanazawa university
None
Self funding
NO
2012 | Year | 12 | Month | 09 | Day |
Unpublished
Open public recruiting
2009 | Year | 06 | Month | 28 | Day |
2012 | Year | 12 | Month | 09 | Day |
2015 | Year | 03 | Month | 31 | Day |
2012 | Year | 12 | Month | 09 | Day |
2012 | Year | 12 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010938
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