Unique ID issued by UMIN | UMIN000007100 |
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Receipt number | R000008363 |
Scientific Title | Phase II study of R-EPOCH for elderly Burkitt lymphoma and intermediate Burkitt lymphoma /diffuse large B cell lymphoma |
Date of disclosure of the study information | 2012/01/23 |
Last modified on | 2016/07/22 11:26:53 |
Phase II study of R-EPOCH for elderly Burkitt lymphoma and intermediate Burkitt lymphoma /diffuse large B cell lymphoma
EPOCH-BL
Phase II study of R-EPOCH for elderly Burkitt lymphoma and intermediate Burkitt lymphoma /diffuse large B cell lymphoma
EPOCH-BL
Japan |
elderly Burkitt lymphoma and intermediate Burkitt lymphoma/diffuse large B cell lymphoma
Hematology and clinical oncology |
Malignancy
NO
The object of this clinical phase II study is to examine the efficacy and safety of R-EPOCH regimen for elderly Burkitt lymphoma and intermediate Burkitt lymphoma/diffuse large B cell lymphoma as first remission induction.
Efficacy
Confirmatory
Pragmatic
Phase II
2 years progression free survival
complete remission rate, 2 years over all survival, safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
6-8 cycles of R-EPOCH are scheduled.
The patients achieved CR after 4 cycles recieve total 6cycles, and the patients achieved PR after 4 cycles recieve total 8 cycles.
65 | years-old | <= |
79 | years-old | >= |
Male and Female
1.pathological diagnosis: Burkitt lymphoma or intermediate Burkitt lymphoma/diffuse large B cell lymphoma
2.CD20 antigen positive
3.no prior therapy for lymphoma
4.lymphoma cells less than 5000/mm3 in peripheral blood
5.presence of mesurable lesions
6.age: 65-79 years old
7.PS(ECOG): 0-2
8.adequate organ funcitions
9.informed consented patients
1.presence of active infeciton
2.presence of central nervous invasion
3.past history of glaucoma.
4.past history of severe drug allergy.
5.HIV Ab positive or HTLV-1 Ab positive.
6.HBsAg positive or HCV Ab positive.
7.severe cardiac disease
8.hepatic cirrhosis
9.uncontrollable diabetis melitus
10.patients with dialysis
11.lung fibrosis or interstitial pneumonitis
12.other active malignancies
13.pregnant or feeding female
14.severe mental disorder
15.judged for inappropriate with other reasons.
40
1st name | |
Middle name | |
Last name | Hirokazu Nagai |
National Hospital Organization Nagoya Medical Center
Clinical Research Center
4-1-1, Sannomaru,Naka-Ku, Nagoya, Japan
052-951-1111
nagaih@nnh.hosp.go.jp
1st name | |
Middle name | |
Last name | Hirokazu Nagai |
National Hospital Organization Nagoya Medical Center
Clinical Research Center
4-1-1, Sannomaru,Naka-Ku, Nagoya, Japan
052-951-1111
nagaih@nnh.hosp.go.jp
Clinical Hematology Study Group of National Hospital Organization(CHSG-NHO)
National Hospital Organization
Government offices of other countries
NO
2012 | Year | 01 | Month | 23 | Day |
Unpublished
No longer recruiting
2012 | Year | 01 | Month | 19 | Day |
2012 | Year | 03 | Month | 01 | Day |
2012 | Year | 01 | Month | 19 | Day |
2016 | Year | 07 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008363
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