Unique ID issued by UMIN | UMIN000010923 |
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Receipt number | R000012783 |
Scientific Title | A clinical phase II study assessing the safety and efficacy of readministration of bendamustine monotherapy or bendamustine/rituximab for relapsed low grade B cell non-Hodgkin lymphoma or mantle cell lymphoma patients previously treated with bendamustine containing chemothearpy |
Date of disclosure of the study information | 2013/06/17 |
Last modified on | 2020/12/15 12:38:23 |
A clinical phase II study assessing the safety and efficacy of readministration of bendamustine monotherapy or bendamustine/rituximab for relapsed low grade B cell non-Hodgkin lymphoma or mantle cell lymphoma patients previously treated with bendamustine containing chemothearpy
Assessment of the safety and efficacy of bendamustine retreatment
A clinical phase II study assessing the safety and efficacy of readministration of bendamustine monotherapy or bendamustine/rituximab for relapsed low grade B cell non-Hodgkin lymphoma or mantle cell lymphoma patients previously treated with bendamustine containing chemothearpy
Assessment of the safety and efficacy of bendamustine retreatment
Japan |
low-grade B cell non-Hodgkin lymphoma, Mantle cell lymphoma
Hematology and clinical oncology |
Malignancy
NO
Overall response rate after 2 cycles of therapy
Safety
Overall response rate after 2 cycles of thearpy
1. Best overall response rate
2. complete response rate
3. progression free survival
4. safety
5. safety and efficacy after each cycle of treatment
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
bendamustine monotherapy or bendamustine/rituximab therapy will be administered
20 | years-old | <= |
Not applicable |
Male and Female
1. Patients who have been diagnosed as histologically confirmed low-grade B cell non-Hodgkin's lymphoma or mantle cell lymphoma
2. Patients who have received bendamustine containing chemothrapy
3. Patients who have maintained reponse(greater than PR) to previous bendamustine containing regimen for over 3 months
4. Patients with measurable disease
5. Patients over 20 years-old
6. ECOG PS of 0 - 2
7. Patients who fulfill the following criteria
ANC > 1,000 /mm3
Hgb > 8.0g /dL
Plt > 75,000 /mm3
AST, ALT < x2.5 ULN
T-Bil <2.0 mg/dl
Cr <2.0 mg/dl
8. Patients with a life expectancy of > 3 months
9. Patients who can give written informed consent to the study
1. patients who are pregnant/female patients who are unwilling to take prevention measures for contraception during treatment
2. patients with active cancer
3. patients wih mental illnesses that the treating physician judges difficult to participate in the study
4. patients with circulating tumor cells > 25,000 /uL
5. patients with severe allergic reaction to medication
6. patients with active infectious diseases
7. patients who are positive for HBs antigen or HBV-DNA
8. patients who are judged inadequate to participate in the study according to the treating physician
38
1st name | |
Middle name | |
Last name | Takayuki Shimizu |
Keio University School of Medicine
Division of Hematology
35 Shinanomachi, Shinjuku-ku, Tokyo
+81-3-3353-1211
taka-sh@keio.jp
1st name | |
Middle name | |
Last name | Koichi Murakami |
Keio University School of Medicine
Division of Hematology
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
+81-3-3353-1211
k.murakami1020@a8.keio.jp
KEIO BRB Study Group
N/A
Other
NO
2013 | Year | 06 | Month | 17 | Day |
Unpublished
Completed
2013 | Year | 06 | Month | 03 | Day |
2013 | Year | 03 | Month | 23 | Day |
2013 | Year | 06 | Month | 17 | Day |
2020 | Year | 06 | Month | 30 | Day |
2020 | Year | 08 | Month | 06 | Day |
2020 | Year | 08 | Month | 06 | Day |
2020 | Year | 08 | Month | 06 | Day |
2013 | Year | 06 | Month | 10 | Day |
2020 | Year | 12 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012783
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