Unique ID issued by UMIN | UMIN000025569 |
---|---|
Receipt number | R000029426 |
Scientific Title | Prospective evaluation of the significance of dose adjustment in rituximab plus CHOP chemotherapy for elderly patients with diffuse large B-cell lymphoma |
Date of disclosure of the study information | 2017/01/10 |
Last modified on | 2017/01/07 00:30:22 |
Prospective evaluation of the significance of dose adjustment in rituximab plus CHOP chemotherapy for elderly patients with diffuse large B-cell lymphoma
PEARL study
Prospective evaluation of the significance of dose adjustment in rituximab plus CHOP chemotherapy for elderly patients with diffuse large B-cell lymphoma
PEARL study
Japan |
Diffuse large B cell lymphoma
Hematology and clinical oncology |
Malignancy
NO
Prospective evaluation of the significance of dose adjustment in rituximab plus CHOP chemotherapy for elderly patients with diffuse large B-cell lymphoma
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
Progression-free survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Rituximab plus dose-adjusted CHOP chemotherapy
70 | years-old | <= |
Not applicable |
Male and Female
(1) histologically diagnosed diffuse large B cell lymphoma by WHO classification 2008.
(2) CD20 positive
(3) No previous chemotherapy or radiotherapy.
(4) Performance Status: between 0 and 3.
(5) No organ dysfuction;
neutrophil count>1000/mm3
platelet count >100000,
AST and ALT level <5 times the upper limit of the normal range, total bilirubin level<2.0 mg/dl,
eGFR>30ml/min
no cardiac dysfunction.
SpO2>92
(6) Understanding and agreement of written informed consent.
(1)testis,CNS invasion/IVL,transformation from loe grade lymphoma
(2)HIV infection
(3)severe infection
(4)Psycological disorder like schizophrenia.
(5)Active or non-curable synchronous malignancy
62
1st name | |
Middle name | |
Last name | Akiko Meguro |
Tochigi Cancer Center
Division of hematology
Yonan4-9-13, Utsunomiya-shi, Tochigi
028-658-5151
akmeguro@tochigi-cc.jp
1st name | |
Middle name | |
Last name | Akiko Meguro |
Tochigi Cancer Center
Division of hematology
Yonan4-9-13, Utsunomiya-shi, Tochigi
028-658-5151
akmeguro@tochigi-cc.jp
Tochigi Cancer Center
None
Other
NO
2017 | Year | 01 | Month | 10 | Day |
Unpublished
Open public recruiting
2017 | Year | 01 | Month | 04 | Day |
2017 | Year | 01 | Month | 04 | Day |
2017 | Year | 01 | Month | 07 | Day |
2017 | Year | 01 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029426
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |